Section 1

Introduction

The ClinicalTrials.gov Protocol Registration and Results System (PRS) is a web-based tool used to submit clinical study information to ClinicalTrials.gov. Records submitted through the PRS are available to the public at ClinicalTrials.gov. This document describes how to use the PRS and provides step-by-step instructions for PRS functions.

Information on applying for an account, registering studies and submitting results, frequently asked questions, and support materials is available on the Submit Studies page of the ClinicalTrials.gov

Section 2

Record Basics: Steps to Posting a Study Record on ClinicalTrials.gov

Description of Protocol Registration and Results System WorkfloW
Posting study information on ClinicalTrials.gov is a multistep process
1. Log in to PRS
  
  You will need to log in to an account linked to the Sponsor Organization of the study you want to register. Typically, the Sponsor Organization is the organization or person who initiates the study. For information on obtaining a PRS account, see How to Apply for an Account.
2. Create a new record
  
  The person who creates the record becomes the Record Owner. All email messages about the record will be sent to this person.
3. Enter (or edit) study information
  
  Provide information summarizing the study protocol, including the Brief Title, Study Type, Outcome Measures, Arms and Interventions, Eligibility Criteria, Contacts, and Study Site Locations. See the Protocol Registration Data Element Definitions and the Expanded Access Data Element Definitions for a complete list of required and optional data elements.
4. Submit the study record for PRS Review
  - After all study information is entered, the person entering the information clicks on Entry Complete.
  - The Responsible Party or Administrator for the study clicks on Approve to accept the content.
  - The Responsible Party or Administrator clicks on Release to submit the record for review by PRS Staff. For more information about identifying the Responsible Party, see Section 3.2: Determining Who Should Submit a Record
5. PRS Staff review the record
  
  After the Responsible Party releases the record, PRS Staff review it for apparent errors, deficiencies, and/or inconsistencies. If PRS Staff find any potential issues with the record, they will add comments to the record and send an email notification. The user must log in to PRS to view the comments. He or she then edits the study record to address the comments and resubmits the record for PRS Review, using the same procedures described in steps 3 and 4.
6. Record is registered and posted
  
  Once the study record passes PRS Review, an email notification will be sent with the ClinicalTrials.gov Identifier (NCT number), indicating that the study is registered. Generally, within 2 business days of registration, the system will post the record on the ClinicalTrials.gov website. Once registered, a study record becomes a permanent part of ClinicalTrials.gov and cannot be removed.
7. Keep record up to date
  
  The study record needs to be verified and/or updated at least once a year (as described in steps 3 and 4), with some data elements requiring more rapid updates, until the study is completed and/or the PRS Review process has concluded for submitted results information.
8. Add results
  
  U.S. law requires some studies to submit results to ClinicalTrials.gov. Generally, results must be submitted within 1 year of the Primary Completion Date. For more information, see the Frequently Asked Questions on the Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11).

Record status

As a record progresses through the PRS, its status changes, as described in Table 1.

Table 1: PRS Record Status

Record Status
Record Status	Description
In Progress	User is creating (or modifying) the record.
Entry Completed	User has finished and clicked on Entry Complete. Record is ready for review by Administrator (or Responsible Party).
Approved	Administrator (or Responsible Party) has reviewed record, made any necessary changes, and clicked on Approve.
Released	Administrator (or Responsible Party) has submitted the record to ClinicalTrials.gov by clicking on Release.
PRS Review	The record is currently being reviewed by the PRS Team. The record is locked while PRS Review is being performed.
Public	The record is or soon will be posted (or updated) on the ClinicalTrials.gov website.

Section 3

Accounts

Overview: Roles and Responsibilities

Anyone who enters clinical study information into the Protocol Registration and Results System (PRS) must have an account. There are several different types of accounts, and the type of account you have will depend on your role. For example, an organization (such as a company, university, or medical center) has an organization account. Each organization should designate one or more PRS Administrators to manage the account and create logins for additional users. Investigators affiliated with that organization or working on studies sponsored by that organization will be designated as users of this organization account. Table 2 shows different roles associated with the PRS and the responsibilities of each.

Table 2: PRS Roles and Responsibilities

PRS Role
PRS Role	Description and Responsibilities
Sponsor Organization	A company, university, medical center, or other research organization that conducts clinical trials. Each study record has a Sponsor Organization, and all PRS accounts associated with that record should be under the Sponsor Organization. Investigators apply to be users of the Sponsor Organization's PRS account. (If an investigator is conducting trials for more than one Sponsor Organization, he or she will need an account from each of those organizations to register the studies properly.)
Administrator	Individual designated by the organization to manage the organization's PRS account, create accounts for users, and serve as the point of contact for PRS Staff. All PRS organization accounts should have at least one Administrator who creates user accounts and oversees the maintenance of the organization's records. When the Sponsor is the Responsible Party (see below), Administrators are responsible for releasing records for PRS Review and posting to ClinicalTrials.gov.
User	Any PRS account holder who is authorized to enter information into the PRS, including investigators or research assistants. Users create and modify their own records, but cannot access other users' records unless authorized by the Record Owner or by an Administrator.
Record Owner	PRS account holder who creates a study record in the PRS. Record Owners can maintain the record themselves or give one or more users access to a record to make changes. An Administrator can change the Record Owner after the record has been created.
Responsible Party	Entity or individual responsible for verifying the accuracy of a study record and releasing it to ClinicalTrials.gov. The Responsible Party for a particular study may be the Sponsor, Sponsor-Investigator, or Principal Investigator. When the Responsible Party is the Sponsor, an Administrator performs these record functions. The person identified as the Responsible Party for the Sponsor Organization account acts as the official contact person for that account and full contact information for that person must be listed in the PRS account.

Determining Who Should Submit a Record

Before applying for a PRS account, you should make sure you're the appropriate person to submit clinical study information. Studies should be registered only by the Responsible Party, although other users can be authorized to add information to the study record either before or after a study is registered.

To help you determine the appropriate Responsible Party for registering a study and submitting results, see the Responsible Party and Sponsor data element definitions.

Each study generally has a Sponsor Organization. Studies must be registered under the Sponsor Organization's account. For example, if you are a Principal Investigator designated to be the Responsible Party for a study and you work for University X, but the Sponsor Organization for the study is University Y, the study must be registered under University Y, and you should set up your PRS account through University Y.

A Contract/Clinical Research Organization (CRO) should not have its own organization account if they are not the responsible party for the studies they want to register. For each study a CRO intends to register, the CRO member will need a user account under the sponsoring organization's account. Note: it is very common for CRO members to possess several user accounts (one under each sponsoring organization), allowing the correct registration of study records sponsored by various institutions.
Applying for an Account

Most users will not apply for a PRS account directly with PRS, but will do so through the Sponsor Organization's PRS Administrator.

If you do not know if the Sponsor Organization has a PRS account or who the Administrator is, follow the steps below:
1. Check the current list of organizations with a PRS account to see if the Sponsor Organization is on the list.
  1. If the Sponsor Organization is on the list, submit a PRS Administrator Contact Request Form to PRS. You will receive contact information for the organization's PRS Administrator(s), whom you can contact directly to request a user login.
  2. If the Sponsor Organization is not on the list, this means the organization does not have a PRS account and must create one before you can register for a user account. You or the organization's management must identify someone to serve as the PRS Administrator for the organization and apply for a PRS organization account. If you are not sure who should be the organization's PRS Administrator, email the PRS Staff at Register@ClinicalTrials.gov to help you identify an appropriate person. The Administrator will apply for the organization's PRS account. As part of that application, the Administrator provides his or her name, phone number, and email address. ClinicalTrials.gov then creates both the organization's PRS account and the Administrator’s account and notifies the Administrator of his or her username and temporary password.
2. Once the Sponsor Organization appears on the list of organizations with a PRS account, you can submit a request to the PRS Administrator to request a user login.
  
  Note: If the Sponsor Organization does not have an organization account or anyone who can serve as a PRS Administrator, you may apply for a PRS individual account. This option is not recommended for most organizations. After an individual account is created, an organization is still encouraged to identify appropriate individuals to act as PRS Administrators for the organization.
  
  PRS Staff will create a PRS account within 2 business days of receiving an application. Once the account has been created, you will receive an email with instructions for logging in to PRS.
Changing User Account Information
1. Update/Modify User Information
  
  To change your PRS username, full name, or email address, follow the steps below:
  1. Log into the PRS and select Update [Username] User Account from the Accounts menu.
  2. Change the information that should be updated and select Save to activate the changes. You will receive an email notifying you of the change(s) after you save.
2. Change Password
  
  To change your PRS password follow the steps below:
  1. Log into the PRS and select Change Password from the Accounts menu.
  2. Enter the password information.
  3. Click on Change Password to save the new password.
3. Find Administrator Information
  
  Your organization's Administrator can help answer questions about your account, record(s), or the PRS.
  
  To find your Administrator, log in to the PRS and select List Administrator(s) from the Accounts menu. You will then be presented with the contact information for each Administrator at your organization.
  
  If your organization assigns Administrators to manage Groups, you will see only the Administrator assigned to your Group.
  
  It's a good idea to note your Administrator's contact information and keep it outside the PRS. The Administrator can reset your password if you forget it.
Administrator Functions

Administrators have three primary responsibilities:
1. Maintain their organization's PRS account, including monitoring for problems with records
2. Approve and release study records and updates when the Sponsor is the Responsible Party (see Section 4, Creating a New Record and Entering Data, for more information on this function).
3. Serve as the primary point of contact with the ClinicalTrials.gov team.
Administrators can create and modify user accounts, designate other users as Administrators, create and manage Groups, and manage the organization's account. Administrator-only functions are shaded in yellow and are visible only to Administrators. The following are the steps for some Administrator functions:
1. Create New User Account
  1. Click on New User Account from the Admin Only section of the Accounts menu.
  2. Complete the fields on the User Registration page:
    - Access Level: Choose Normal for users or Administrator
    - Username: Enter user login name (e.g., first initial plus last name).
    - Full User Name: Enter full first name followed by last name (Note: this information will be displayed publicly when the Investigator is the Responsible Party; ensure that the information is properly formatted and there are no spelling errors).
    - Other User Information: Enter additional information about the user (include phone number to make it easier to contact the user).
    - User Email: Enter email address of user.
    - Send optional (PRS-generated) email messages: This is checked by default. Administrators may uncheck to eliminate email notifications when users complete data entry for records or reset records to in-progress (not recommended).
  3. Click on Register to accept account information and generate automatic email notification to the user of the new account.
2. Update/Modify User Account Information
  1. Click on Modify User Account/Password from the Admin Only section of the Accounts menu.
  2. Click on Modify next to the username for the account to be updated.
  3. Enter changes on the User Information page.
  4. Click Save.
3. Change User Password
  1. Click on Modify User Account/Password from the Admin Only section of the Accounts menu.
  2. Click on Reset Password next to the username for which the password is to be reset.
  3. Enter and confirm a new password.
  4. Click on Reset Password. The new password will be emailed automatically to the user.
4. Disable/Enable User Account
  1. Click on Enable/Disable Account from the Admin Only section of the Accounts menu.
  2. Click on Enable/Disable next to the username corresponding to the account to be enabled/disabled.
  3. Click on Enable/Disable to confirm the operation.
  4. Select a new user to transfer ownership of the user's record(s).
5. Maintaining Organization Accounts
  
  The basic organization account information is set up when the administrator first applies for a PRS organization account, but this information can be updated as needed.
  
  Modify Organization Information
  1. Click on Modify Organization Information from the Admin Only section of the Accounts menu.
  2. Update the fields on the Organization Information page as needed.
  3. Click on Save.
  Note: Only PRS Staff can change the name of an organization. To change an organization's name, the Administrator must make the request to PRS through the Contact ClinicalTrials.gov link located in the upper right corner of the PRS or by email to Register@ClinicalTrials.gov.
6. Manage Groups
  
  Larger organizations may wish to divide users into groups, with each group having one or more Administrators. When users are added to a group, their records will also be part of the group. Some things to keep in mind about groups:
  - By default, only the records owned by users within an Administrator’s group show up on their Record List. Administrators can see other records by selecting another group or [All] in the Record List Group dropdown menu.
  - Users within a group can only see the Administrator(s) assigned to their group. Administrators can access user accounts outside their group by selecting another group or [All] on the Modify User Account/Password page.
  - Some Administrators and/or users may be unassigned. Unassigned Administrators see all of the organization's records and user accounts by default.
  - Automatic email messages (e.g., a message indicating that a record has been updated by a user) are sent only to those Administrators assigned to the group associated with the user in question.
  - Any Administrator can modify group assignments within an organization.
  Specific functions for managing groups
  Create a Group
  1. Click Manage Groups from the Admin Only section of the Accounts menu.
  2. Click on New Group...
  3. Fill in requested information.
  4. Select Administrator(s) and users.
  5. Click Create.
  Modify a Group
  1. Click Manage Groups from the Admin Only section of the Accounts menu.
  2. Click Edit next to the group to be modified.
  3. Make the desired changes.
  4. Click Save.
7. List Email Addresses
  
  The List Email Addresses feature provides a list of all users and Administrators at your organization.
  
  To access the list, click List Email Addresses from the Admin Only section of the Accounts menu.
8. Lookup User
  
  Lookup User on the Home page under Quick Links allows an administrator to find users by full name, email address, or username. The administrator can then view the list of records that are owned or can be accessed by the user.
9. Product Information
  
  The Product Information feature allows Administrators to link U.S. Food and Drug Administration (FDA)-approved products with associated clinical trials. This feature is for Administrators' use only and can assist in managing studies.
  
  To access the Product Information feature, click on Product Information from the Admin Only section of the Accounts menu. Click on Create to start a new Product Information record. You can edit Product Information records at any time.
Reports (Administrators Only)

There are three types of reports that Administrators can use to help track the progress of study records associated with their PRS account.
1. Planning Report
  
  The Planning Report assists Administrators in coordinating updates, corrections, and results submissions for all of an organization's records. The Administrator can view and download the report, which includes the expected date for updates, corrections, and results submission, when applicable.
  
  To access the Planning Report function
  1. Click on Planning Report from the Admin Only section of the Records menu.
  2. Click on the Show/Hide button to select which columns to display on the report.
  3. Click on the Action Expected button to narrow the report to only records that appear to need updating, corrections, or results submission. The Custom Filter button can be used to further narrow the report.
  4. Click on Download Spreadsheet to download the Planning Report as a .csv file.
  FDAAA Status
  
  The report also includes the FDAAA column, which indicates if a record is a probable Applicable Clinical Trial (pACT) or an Applicable Clinical Trial (ACT) that appears to be subject to the requirements of Section 801 of the Food and Drug Amendments Act (FDAAA 801) or 42 CFR Part 11. This indication is for informational purposes only. The Responsible Party must make the determination as to whether a study is an ACT. For more information, see Section 8, Table 4: FDAAA 801 Problems.
  
  NIH Grants
  
  To assist in identifying study records that may be subject to the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information, the NIH Grants column identifies records that list an NIH grant number or include an NIH Institute or Center as a Collaborator. This indication is for informational purposes only. The Responsible Party must make the determination as to whether a trial is subject to the NIH Policy.
  
  Results Expected
  
  The Results Expected and All Results Expected columns indicate the anticipated dates by which results information must be submitted. These columns only calculate dates for records identified by the PRS to be probable applicable clinical trials (pACTs) or applicable clinical trials (ACTs), as indicated by the FDAAA Status in the Record Status box on the Record Summary page or in the Planning Report. For information on how the Results Expected and All Results Expected dates are calculated for a specific record, click on the date link.
  
  IMPORTANT: Results expected dates displayed in the PRS are provided for informational purposes only. The responsible party must make the determination as to if and when results information is due according to the requirements of FDAAA and 42 CFR Part 11.
  - The Results Expected column indicates the date by which results information, including primary and secondary outcome measures, is required to be submitted. This date is calculated as 1 year after the Primary Completion Date, unless a certification or extension request is submitted to delay the deadline for results information submission.
    - If a certification is submitted, this date is calculated as 2 years after the date of submission of the certification, which reflects the maximum possible delay for results information submission. Submission of results information may be required sooner if any of the events specified in 42 CFR 11.44 occur.
  - The All Results Expected column indicates the latest possible date by which all secondary outcome measure or adverse event information must be submitted. This date is calculated as 1 year after the Study Completion Date, unless a certification or extension request is submitted to delay the deadline for results information submission.
    - If a certification is submitted, this date is calculated as 2 years after the date of submission of the certification, which reflects the maximum possible delay for results information submission. Submission of results information may be required sooner if any of the events specified in 42 CFR 11.44 occur.
  Results information, including each primary and secondary outcome measure, must generally be submitted within 1 year of the Primary Completion Date for applicable clinical trials required to be registered (as described in 42 CFR 11.42 and 11.44).
  
  For clinical trials with more than one primary outcome measure with different completion dates, the Primary Completion Date is the date when data collection is completed for all primary outcome measures.
  
  If any secondary outcome measure or additional adverse event information have not been collected by the Primary Completion Date, then this information must generally be submitted within 1 year of the final subject being examined or receiving an intervention for the purposes of final collection of data for that secondary outcome measure or adverse event information.
  
  Some secondary outcome measures and/or adverse event information may be due between the Primary Completion Date and the Study Completion Date. Neither the Results Expected or All Results Expected dates are intended to calculate the submission deadlines for this information. The Responsible Party must make the determination as to if and when specific results information is due.
2. Public Site Report
  
  The Public Site Report lists records that have an NCT number and have been or are going to be posted on the ClinicalTrials.gov public website. The report also includes records that were posted to the site and then made No longer public (for example, if the record was marked as a duplicate of another study record).
  1. The Public Site Status dropdown menu controls which records are displayed.
    - Choose Public to see only records currently on the site or about to be posted.
    - Choose Not Public to see only records marked as No Longer Public.
    - Choose ALL to see both types.
  2. Click on Download Spreadsheet to download the Public Site Report as a .csv file.
3. Record Information Download
  
  The Record Information Download provides a list of data elements that can be downloaded into a .csv file. To access the Record Information Download function:
  1. Click on Record Information Download from the Admin Only section of the Records menu.
  2. Select the data elements fields that you would like for your report. To select all fields, click on the Select All button at the bottom of the data fields. To unselect all choices, click Clear at the bottom of the page. Each data element will display as a column on the report.
  3. Once all the desired data fields are selected, click Download to download the Record Information as a .csv file.
  4. To get back to the home page, click Done.
4. Review History Download
  
  The Review History Download provides review history information for all records as comma-separated values, readable by spreadsheet applications. To access the Review History Download function:
  1. Click on Review History Download from the Admin Only section of the Records menu.
  2. Click Download to download the Review History as a .csv file.
  3. To get back to the home page, click Done.

Section 4

Creating a New Record and Entering Data

This section describes the steps to creating a new record and entering data.

To register a study, you will first need to create a record in the PRS and enter information about the study. When entering information into your record, you will need to complete a series of topic-specific modules. All information entered may be modified later. For more information on the required and optional data elements needed to provide summary protocol and results information, see the Protocol Registration Data Element Definitions, Expanded Access Data Element Definitions, and Results Data Element Definitions.

How to Create a New Record

A record may be created directly within the PRS, or created offline as an XML file and then uploaded. This section will cover how to create a new record within the PRS. For information on how to create an XML upload, see Section 9: Record Upload/Download.

A record may be created in a single session or created and saved for completion at later sessions. To create a record during a single session:
1. New Record
  
  From the PRS home page, use either the New Record Quick Link or select New Record under the Records menu. Both will take you to the Create New Record page.
2. Enter the Unique Protocol ID, Brief Title, and Study Type
  
  Enter the Unique Protocol ID, Brief Title, and Study Type (interventional, observational, or expanded access) for your record on the Create New Record page. Note: The Unique Protocol ID may be assigned by your organization. If the study has not been assigned a Unique Protocol ID, please use any another unique identifier for your record, such as your IRB approval number.
3. Click Continue
  
  Click Continue to save data and proceed to the next module.
4. Repeat data entry and click Continue for each module
  
  Repeat data entry and click Continue for each module. When you get to the Edit Arms page, click on + Add Arm and fill in the data for each arm of the study. Click Continue after adding the last arm.
5. Click Continue and then Quit on the next module
  
  To create a record and save for completion at later sessions, click Continue and then Quit on the next module. Data is saved only after you click on Continue. To continue editing your record, follow the steps in Section 7: Modifying a Record.
6. Follow instructions in Section 5
  
  After clicking Continue on the final data entry page (Edit References), follow the instructions in Section 5: Preparing, Approving, and Releasing a Study Record to PRS.
Data Entry Tips
1. Formatting Text
  - For multi-line text fields in the PRS, the following conventions allow formatting options such as paragraphs and lists.
  - To format paragraphs, include a blank line between paragraphs.
  - To format bulleted lists, start each list item on a new line with a "list item" character, such as a hyphen (-) or an asterisk (*), followed by a space and then the item text. Follow the list with a blank line, to add a paragraph following the list. For example:
    First paragraph.
    - list item one
    - list item two
    Next paragraph.
  - To format numbered lists use sequential numbers, starting with "1" (or "1."), as the list item characters. Alternatively, use lower case letters, starting with "a.", as list item characters.
  - Bulleted, numbered and lettered lists may be combined in order to create a list within a list. For example:
    - list item one
      1. list item 1a
      2. list item 1b
        
        bullet one
        
        bullet two
    - list item two
    ...
  - Use the "Preview" feature to see how the text will appear on ClinicalTrials.gov.
2. Formatting Eligibility Criteria
  
  The Eligibility Criteria data element has a default format specified with a header for Inclusion Criteria and a header for Exclusion Criteria. Each criterion is entered below the header using a bulleted list like this:
  Inclusion Criteria:
  - item
  Exclusion Criteria:
  - item
  - Put each eligibility item on a separate line. Press the Enter key after entering text for each line.
  - Start each line of a bulleted list with two spaces, a hyphen, and a space ( - ) before entering the text.
  - If necessary, combine bulleted, numbered, and lettered lists in order to create lists within a list. For example:
    - list item one
      1. list item 1a
      2. list item 1b
        
        bullet one
        
        bullet two
    - list item two
3. Special Characters
  
  The standard character set for ClinicalTrials.gov is Unicode, with UTF-8 encoding. When you access the PRS website, your web browser is automatically set for UTF-8, so typically no adjustments are required.
  
  Problems with special characters (for example, symbols or non-English letters) most often occur when text is copied from a document that was created with a character encoding scheme other than UTF-8, and pasted directly into a field in the PRS, such as in the Protocol Section. Most of the characters look fine, while certain special characters are invisible or are replaced with a character other than the one intended.
  
  On a Windows PC, the Character Map accessory can be used to insert special characters that are not found on the keyboard. (The Character Map is generally accessible by searching for "Character Map" the Windows Start menu.) If you cannot find the character that you wish to insert, you may need to select a different font in Character Map, such as the Arial Unicode MS font. It might also be necessary to select a different font in your browser preferences, so that characters are visible in the PRS websites. Other computer systems usually provide a tool that is similar to the Windows Character Map.
  These commonly used special characters can be copied from this page and pasted into PRS data entry fields: ≤ ≥ ° ± µ ™ ®
  When using copy/paste to enter protocol information, review the text entered into the record carefully. In general, if you can see the correct characters in the fields within the PRS, the encoding is correct. Make edits as needed using the method described above.
Optional versus Required Fields

ClinicalTrials.gov requires certain data elements to be entered before the record can be submitted for PRS Review and posting. Optional fields are not required for posting on ClinicalTrials.gov, but may be required to comply with FDAAA 801 or meet the requirements of other organizations (such as medical journals or funding sources). You should verify any requirements by your institution and any external organizations that may be using the study record.

For information on the required and optional data elements needed to provide summary protocol and results information, see the Protocol Registration Data Element Definitions, Expanded Access Data Element Definitions, and Results Data Element Definitions.
System Validation Messages: Errors, Warnings, Notes

The PRS will automatically detect some data entry issues when you save each module, and alert you when there are possible problems. Errors or incomplete information in one module may create data validation issues in another module. You may need to correct or add information in different modules to address all validation messages on your record.
ERROR messages indicate serious issues that must be addressed. WARNING messages indicate potentially serious issues that should be reviewed and addressed as needed. NOTE messages indicate potential issues that should be reviewed and addressed as needed.
ERROR messages need to be addressed before releasing the record for PRS Review. The other messages indicate items that should be evaluated carefully and, if not addressed, may lead to identification of issues during the PRS Review process.
Record Access List

The Record Owner and the Administrator by default have access to the record and can add information or modify information in that record. The Record Owner or Administrator can grant access to additional users by using the record's Access List. Users on a record's Access List can update and edit a record.

To update the Access List, use the Edit Access List link on the Record Summary page and select the usernames of people who should have access to the record.

When users are added to an Access List, the record will be available through their Record List.

Section 5

Preparing, Approving, and Releasing a Study Record to PRS

Before releasing a record to PRS Staff for review, read it over carefully to make sure it is accurate, complete, and free of errors. Here are steps to follow and tools you can use to prepare and release your record.

Data Entry Review

Look your record over carefully to ensure that it does not contain spelling or other mistakes, and check that it is formatted correctly and clearly. The following links and features available from the Record Summary page can help with this process:
1. Draft Receipt
  
  The Draft Receipt function provides a copy of your record as it currently appears in the PRS. You can download the Draft Receipt as either an Adobe PDF or RTF (rich text format) file. The format of the draft receipt reflects the PRS content order.
  
  You can import the RTF file into a word processing program, such as Microsoft Word. This is useful for editing and sharing a record with co-workers or colleagues who don't have a PRS User account. Note that changes made to the RTF file will need to be entered back into the PRS system into the appropriate modules.
  
  To download a Draft Receipt, open your record from your Record List, find Draft Receipt option on the Record Summary page, and select link to either PDF or RTF below the Record Status box.
  
  If you would like to save the record with system validation messages (see Section 4.4: System Validation Messages), download a PDF and choose Yes to the question Include Validation Messages in PDF?
2. Preview
  
  Use the Preview feature to see approximately how the text will appear on ClinicalTrials.gov. Once your entry is complete, select Preview to see how your record will appear on the public website.
  1. Select Preview on the Record Summary page.
  2. On the Protocol Registration Preview page, examine data for accuracy. Review the Brief Title and Brief Summary to see if language will be easily understood by website users. Check that formatting in Brief Summary and Eligibility Criteria allows for ease of reading.
  3. Select Close to return to Record Summary page. Edit the record to make any changes that are needed.
3. Spelling and Acronym Checkers
  
  The PRS System has a Spelling Checker that checks free-text data elements, such as Brief Title and Detailed Description. You can access this via the Spelling link on the Record Summary page. The Spelling Checker may not recognize some words, such as newer drug names. The PRS Spelling Checker does not check certain types of words for accuracy. This includes acronyms (all uppercase or mixed-case) and chemical names (combinations of letters and numbers).
  
  The Acronym Checker flags possible unexpanded acronyms in your record. PRS Review criteria calls for all acronyms to be spelled out on first mention in the Protocol Section and Results Section of the study record. For example, the first mention of National Institutes of Health should be followed in parentheses by (NIH). Note that the Acronym Checker does not check the accuracy of the acronym or of the expanded term.
4. PRS Review Criteria
  
  PRS Staff rely on two sets of criteria when reviewing summary protocol and results information in study records:
  - ClinicalTrials.gov Protocol Review Criteria (PDF)
  - ClinicalTrials.gov Results Review Criteria (PDF)
  It is strongly recommended that you check these criteria against your study record
Approving a Record

The Approval process differs depending on the Sponsor Organization or Responsible Party for the study record. If the Responsible Party is the Sponsor, an Administrator—acting as the agent of the Sponsor Organization—approves records. If the Principal Investigator or Sponsor-Investigator is the Responsible Party, the Principal Investigator must approve the record, even if he or she is not an Administrator.

A record must be approved before it can be released to the PRS for PRS Review.
1. How to Submit a Record for Approval
  
  When you have entered information for all the modules of the record, you are ready to submit the record to your Administrator for approval.
  1. In the Record List on your Home page, select Open next to the record you wish to submit.
  2. Review the record and make any necessary changes. Address any system validation messages (see Section 4.4: System Validation Messages).
  3. Select Entry Complete in the Next Action area near the top of the Record Summary page. This generates an automatic email notification to the Administrator indicating that the record is complete and ready for their review.
  Your Administrator will review the record. Once approved, the Administrator can also release the record to PRS Staff for review.
2. How to Approve a Record for Release to PRS
  
  After users create and mark the record as Entry Complete, an automatic email notification is sent to the Responsible Party. The process is the same no matter who is responsible for approving and releasing the record:
  1. Use the Record List custom filter to check for records that are Ready for Review and Approval. A system-generated email notification of completed records will also be sent.
  2. Select Open Record on your Record List.
  3. Review the record by following steps described in Section 5.1: Data Entry Review.
  4. Update Record Verification Date to the current month and year.
  5. Select Approve on the Record Summary page.
Releasing a Record
After the record is approved, the last step is for the Responsible Party to release it for PRS Review.
When a Principal Investigator or Sponsor-Investigator is designated as the Responsible Party for a record, it is the Principal Investigator or Sponsor-Investigator who must Release the record for PRS Review. When the Sponsor is designated as the Responsible Party for a record, an Administrator must Release the record.

The steps are the same whether an Administrator, Principal Investigator, or Sponsor-Investigator must release the record:
1. In the Record List on your Home page, select Open next to the record you wish to submit.
2. Review the record for accuracy and make changes if needed.
3. Select Release on the Record Summary page.
4. Check the box to update Verification Date automatically.
5. Select Release to submit the record to ClinicalTrials.gov for PRS Review.
After a record is released, it undergoes PRS Review. If the PRS team requires further changes, the record is returned so changes can be made and the Release process must be repeated. If the record meets PRS Review criteria, it is posted on the ClinicalTrials.gov website and is available to the public.

Note: If an Administrator makes changes to an Approved record, it does not need to be Approved again. However, the record must still be Released.
1. Batch Release
  
  Administrators can release several records at once to PRS Review, if the Sponsor is the Responsible Party for all the records.
  1. Select Batch Record Release under the Records section of the PRS main menu.
  2. All approved (but not yet released) records are listed. Use the checkboxes to select the records to be released, or choose Select All to select all records.
  3. Select Release. All selected records will be submitted for PRS Review
2. Check Batch Release Status
  
  To check records that have been sent for PRS Review via Batch Release, select Check Batch Release Status from the Records section of the PRS main menu.
  
  The status will inform you if records have been released for review.
Receipts and Past Releases
1. Requesting a Receipt
  
  The Receipt function provides a copy of your record as it appeared in your most recent release (the "Last Release"). To download a PDF Receipt, open your record from your Record List and select Receipt in the Record Status box. You can use the Receipt functions to save versions of your record. Only a PDF version is available for the final receipt.
  
  You can only download a Receipt after a record has been released.
2. Viewing Past Releases
  
  All Released versions of your record are available through the View Release link in the Review History.
  
  To view all Released versions of your record, select the Review History link on the Record Summary page. Then, select View Release for the version of the record you would like to see.

Section 6

PRS Review Process

Anytime the Responsible Party releases a study record, PRS Staff will review it for apparent errors, deficiencies, and/or inconsistencies based on the PRS Review Criteria.

Review of records with registration information may take approximately 2 to 5 business days. Review of records with results information may take up to 30 days.

If PRS Staff identify potential issues with the study record, they will add comments to your record. Comments identified as Major Comments must be corrected or addressed. Comments identified as Advisory Comments should be addressed to improve the clarity of the record. When PRS staff identify potential issues during review, an email notification is sent to the Record Owner with instructions for viewing the PRS Review Comments. Others receiving the email notification include the last user to update the record and the Responsible Party, if a Principal Investigator or Sponsor-Investigator.

Studies will not be posted until all Major Comments have been addressed, except for certain applicable clinical trials. A study record will be posted publicly with Major Comments if it meets the following criteria:

Is an applicable clinical trial
Has a study start date that is on or after January 18, 2017
First submitted results information on or after January 1, 2020

Consistent with 42 CFR Part 11, the National Library of Medicine will publicly post submitted results information for studies meeting these criteria within 30 days of submission, regardless of whether the quality control (QC) review process is complete. A general note that the QC review process has not concluded will be included on the record.

The Major Comments List contains the brief, standard portion of all Major Comments that may be provided to the responsible party during QC review. This list is updated as Major Comments are added or retired from use.

The Responsible Party must ensure Major Comments are addressed within 15 calendar days (registration information) or 25 calendar days (results information) of the date on which PRS Staff sent the notification. The Corrections Expected date is indicated in the Record Status box on the Record Summary page.

Administrators can use the Planning Report to identify when comments must be addressed using the Corrections Expected column. For more information on the Planning Report, see Section 3.6.1: Planning Report.

If you have questions about PRS Review Comments, you can request assistance via email to: Register@ClinicalTrials.gov.

Identifying Records with PRS Review Comments

To see which of your study records have pending PRS Review Comments, check your Record List for the red flag symbol. Each record that contains PRS Review Comments (Major Comments and/or Advisory Comments) will display the red flag symbol. You can also use the Custom Filter on your Record List to display only records flagged with PRS Review Comments. Red flag symbols will appear any time comments are added to a record after PRS Review, including after a record has been posted publicly with Advisory Comments.

If a record has not yet been posted and has PRS Review Comments, you will also see a notification in the Problems column of your Record List indicating there are "PRS Review Comments" on your record. The PRS Review Comments Problem shown on the Record List indicates that comments must be addressed and the record released again to be processed for review and posting on the ClinicalTrials.gov website. This Problem is intended to help Responsible Parties ensure Major Comments are addressed. For more information, see Table 3: Data Entry Problems.
View PRS Review Comments

To read PRS Review Comments, find the relevant record from the Record List and open it. A flag will appear next to each section and module of the study record that has at least one PRS Review Comment to be addressed.

To read the comments, select the Review Comments box in the section or module.

To view all PRS Review Comments ever received on a record, select the Review History link on the Record Summary page. Then, select Review Comments for the version of the record you would like to see.
Editing a Record with PRS Review Comments

If you need to edit your record after receiving PRS Review Comments, follow these steps:
1. In the Record List on your Home page, select Open next to the record you wish to submit.
2. Review the record for accuracy and make changes if needed.
3. Select Release on the Record Summary page.
4. Check the box to update Verification Date automatically.
5. Select Release to submit the record to ClinicalTrials.gov for PRS Review.

Section 7

Updating and Maintaining Records

Once a record is created, you will need to modify it occasionally to make edits, update information, and enter results. This section discusses how to modify an existing record, as well as some other functions related to record maintenance.

Modifying a Record

There are two methods by which you can edit a record. You can either select Edit All to make changes in multiple modules at once, or edit specific modules.
1. Edit All: Module Walk-Through
  
  To walk through your entire record and make changes as needed:
  1. In the Record List on your Home page, select Open next to the record you wish to edit.
  2. Select Open next to the section of the record (Protocol, Results, or Delayed Results) to be modified on the Record Summary page.
  3. Select Edit All to start the step-by-step walk-through.
  4. Make changes as needed on each module.
  5. Select Continue to save the changes and move to next module. Select Quit to save changes and exit the walk-through at any time.
  6. Follow the steps to release your record.
2. Edit a Module
  
  To edit specific modules in your record:
  1. In the Record List on your Home page, select Open next to the record you wish to edit.
  2. Select Open next to the section of the record (Protocol, Results, or Delayed Results) to be modified on the Record Summary page.
  3. Locate the data field to be modified and select Open or Edit for the corresponding module.
  4. Make changes on the data entry page.
  5. Select Save to save the changes and return to the section page. Repeat steps 3-6 for all modules to be modified.
  6. Update the Record Verification Date data field to the current date.
  7. Follow the steps to release your record.
Contact Users

Sometimes you may need to contact the Record Owner (or the user who most recently updated your record) so that they can make some modifications. To do so, open the record and select the letter icon next to the username in the Record Owner or Last Update field. This will open an email to that user.
Changing Record Owner (Administrators Only)

An Administrator can change the Record Owner to another user at the same organization. To do so:
1. Select Open Record from your Record List.
2. Select Change Owner in the yellow-shaded Admin Only box.
3. Choose new owner's username from the list.
Transferring a Record to/from a Different Organization

If the Sponsor of a study has changed or if the Responsible Party has moved to another organization, PRS Staff can assist in transferring a record to another PRS account. Records are registered under their sponsoring organization's account. Therefore, a sponsored study must stay in the account of its sponsor even if/when an associated investigator leaves that institution. The investigator can still work on the record using their existing account. A study record should only be transferred if the sponsor of the study has changed. An Administrator, Responsible Party, or Record Owner can request the transfer by emailing PRS Staff at Register@ClinicalTrials.gov.

Transfers must be coordinated between the organizations involved. If the receiving organization has Administrators, they are responsible for coordinating the transfer. For organizations without Administrators, the Responsible Party and Record Owners must coordinate the transfer.

To complete a record transfer, PRS Staff must receive:
- Confirmation from the receiving organization or Responsible Party that the record will be accepted (a copy of email confirmation is acceptable)
- Name of the receiving organization
- Username of the new Record Owner
- NCT number of the record
Note: Records in a Released state cannot be transferred.
Copying a Record (Administrators Only)

If necessary, Administrators can make a new copy of a record. To do so:
1. Select Open Record from your Record List.
2. Select Copy Protocol in the yellow-shaded Admin Only box.
3. Create a new Protocol ID and Brief Title for the copied record.
4. Edit record as needed.
Deleting a Record or Results Section
1. Deleting a Record
  
  Records that have an NCT number cannot be deleted.
  
  To delete an entire unreleased Record:
  1. Select Open next to the record to be deleted from the Record List on the Home page.
  2. Select the Delete... link.
  3. Select Delete on the Delete Record page or select Cancel to return to the Record Summary page without deleting the record.
  Note: A deleted record can be recovered by an Administrator using the Undelete function, available under the Records section of the PRS main menu.
2. Deleting the Results Section
  
  The Results Section should not be deleted if results are required to be submitted.
  
  The Results Section may be deleted from a record that has not been Released. This function can be used if the Results Section was started by mistake. Use the Delete Results... link near the top of the Results: Overview page to remove the entire Results Section from a record.
  
  If the Results Section has been Released, contact Register@ClinicalTrials.gov for assistance with deleting the Results Section.
Record Log

The Record Log allows you to enter information about a record that will be visible to all users with access to the record and PRS staff. The Record Log may also include entries that track ClinicalTrials.gov PRS activity on a record, such as automatically logging when a record is transferred from another organization or when PRS Staff make minor edits to a record. Entries that are added automatically are tagged with "ClinicalTrials.gov".

Record Log entries are not shown publicly, but can be viewed by PRS Staff. The Record Log should not be used to communicate with PRS Staff. Questions about a study record or PRS Review Comments should be sent via email to Register@ClinicalTrials.gov

To add an entry to the Record Log follow the steps below:
1. Select Open Record from your Record List.
2. Select the Add link next to the Record log.
3. Enter your Log Entry and select Save.

Section 8

Problems with Records and How to Resolve

Several kinds of issues can trigger a record being identified as having problems. This section describes possible problems with study records and how to resolve them.

Monitor the Problems column of your Record List to identify any records with issues. You may also receive emails from the PRS if problems are not resolved.

Once you have addressed the problem by editing the study record as directed, the Responsible Party (or an Administrator, Sponsor-Investigator, or Principal Investigator) must release the record for PRS Review again.

Identifying and Resolving Records with Problems

Problems will be listed in your Record List. When viewing your Record List on your home page, review the Problems column to identify any Problems on your records.

Administrators can use the Custom Filter on the Record List to show only records with specific problems. To use this feature, select Custom Filter, then check off appropriate Problem Records filter button(s).

Follow the steps identified in Table 3, Table 4, and Table 5 to address each problem. The problems will remain listed until the issues are addressed and posted to ClinicalTrials.gov.

When problems occur, they usually fall into three main categories:

Data Entry Problems
FDAAA 801 Problems
PRS Administrator Problems

Use the tables in this section to determine how to resolve any Problems on your study record. Once the issue is resolved, it will automatically be removed from the Problems column on your PRS Home page. Note that the record may need to be posted on ClinicalTrials.gov before the problem is removed.

Note: The Responsible Party (an Administrator or Principal Investigator) must release a study record whenever it is modified for the changes to appear on ClinicalTrials.gov.

Data Entry Problems

Consult Table 3 for a list of common Data Entry Problems, along with their solutions.

Table 3: Data Entry Problems

Data Entry Problems
Data Entry Problems	Solution
Pending PRS Review Comments Potential issues were identified during PRS Review. PRS Review Comments must be addressed and the record released again for the record to be processed for posting on the ClinicalTrials.gov website.	Record Owner: Open the record and read the PRS Review Comments. Modify the record as needed to address the comments. Select Entry Complete. Administrator/Responsible Party: Review and edit as needed. Select Approve and Release to submit the record to ClinicalTrials.gov for PRS Review (see Section 5: Preparing, Approving, and Releasing a Study Record to PRS).
Entry Not Completed The record has been created or modified, but it has not been marked as Entry Complete. A record must be marked as completed, approved, and released before it can be reviewed by PRS Staff and made public (or updated) on the ClinicalTrials.gov website.	Record Owner: Review the record and modify it if necessary. Select Entry Complete. Administrator/Responsible Party: Review and edit as needed. Select Approve and Release the record to submit the record to ClinicalTrials.gov for PRS Review (see Section 5: Preparing, Approving, and Releasing a Study Record to PRS). Note: If the study does not need to be made public (registered) on ClinicalTrials.gov and the record has never been released, you can delete the record.
Not Recently Updated The record has not been recently updated. This applies only to active studies, with an Overall Recruitment Status other than Completed, Terminated, or Withdrawn. A record must be updated at least once every 12 months, and some data elements must be updated sooner (e.g., within 30 days of a change) based on the requirements in Section 801 of FDAAA and 42 CFR 11.64.	Record Owner: Review the record for accuracy and modify it as needed. Update the Verification Date. Select Entry Complete. Administrator/Responsible Party: Review and edit as needed. Select Approve and Release to submit the record to ClinicalTrials.gov for PRS Review (see Section 5: Preparing, Approving, and Releasing a Study Record to PRS). Note: This problem will continue to be listed for the record until the updated record has been released and PRS Review has concluded.
Record Has Errors The record has one or more error messages. Note that errors can arise due to the passage of time (for example, anticipated Primary Completion Date in the past).	Record Owner: Modify the record as needed to address the errors. Select Entry Complete. Administrator/Responsible Party: Review and edit as needed. Select Approve and Release to submit the record to ClinicalTrials.gov for PRS Review (see Section 5: Preparing, Approving, and Releasing a Study Record to PRS).

FDAAA 801 Problems

Under Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) and the Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11), the Responsible Party is required to submit information for specific data elements when registering applicable clinical trials (ACTs). For some of these trials, the Responsible Party is also required to submit summary results information.

The PRS flags records for possible FDAAA or Final Rule issues (in the Problems column of the Record List on the PRS home page) to help Responsible Parties identify trials that are missing one or more FDAAA-required registration data elements. See "Missing FDAAA Information" in Table 4.

The PRS notifies the Responsible Party if summary results information, including all primary outcome measures, has not been posted to ClinicalTrials.gov more than 12 months past the Primary Completion Date (or the Study Completion Date, if the Primary Completion Date has not been specified), unless a certification or extension request is submitted to delay the deadline for results information submission under FDAAA or 42 CFR Part 11. See "Late Results - per FDAAA" in Table 4.

The Responsible Party will also be notified in the PRS if results information for one or more secondary outcome measures has not been posted more than 12 months past the Study Completion Date, unless a certification or extension request is submitted to delay the deadline for results information submission under FDAAA or 42 CFR Part 11. See "Incomplete Results - per FDAAA" in Table 4.

For more information on when results information is expected, see "Results Expected" in Section 3.6.1 Planning Report. Note that results information, including each primary and secondary outcome measure, must generally be submitted within 1 year of the Primary Completion Date for applicable clinical trials required to be registered (as described in 42 CFR 11.42 and 11.44).

IMPORTANT: Problems identified by the PRS concerning possible FDAAA or 42 CFR Part 11 issues are provided for informational purposes only. The PRS identifies records that appear to be probable ACTs (pACTs) or ACTs based solely on information submitted for the data elements listed below. These records should be carefully reviewed, but the records identified with FDAAA or 42 CFR Part 11 issues may not be comprehensive (it may include records for trials that are not ACTs or exclude records for trials that are ACTs). The Responsible Party must make the determination as to whether a specific trial is an ACT subject to the requirements of FDAAA and the 42 CFR Part 11. Additional information on the definition of ACT is provided in the Checklist And Elaboration for Evaluating Whether a Clinical Trial or Study is an Applicable Clinical Trial (PDF).

Records that meet the conditions listed below will be flagged for FDAAA or 42 CFR Part 11 issues. To avoid unnecessary problems concerning FDAAA or 42 CFR Part 11 issues, please verify that the information submitted for the following data elements are correct and completely specified, as applicable:

Probable Applicable Clinical Trial (pACT)

Study Type: Interventional
Intervention Type: Drug, Device, Biological/Vaccine, Radiation, Genetic, Combination Product, or Diagnostic Test
Study Phase: Not Phase 1 or Primary Purpose: Not Device Feasibility
Any of the following apply:
- Facility Location(s): At least 1 U.S. location or locations not specified, or
- U.S. FDA IND or IDE: Is "Yes"
Primary Completion Date: On or after January 2008 or not specified, or
Study Completion Date: On or after January 2008, if Primary Completion Date not specified
Overall Recruitment Status: Not Withdrawn
Study Start Date: Before January 18, 2017

Applicable Clinical Trial (ACT)

Study Type: Interventional
U.S. FDA-regulated Drug Product: Is "Yes" or U.S. FDA-regulated Device Product: Is "Yes"
Study Phase: Not Phase 1 or Primary Purpose: Not Device Feasibility
Any of the following apply:
- Facility Location(s): At least 1 U.S. location or locations not specified, or
- U.S. FDA IND or IDE: Is "Yes" or
- Product Manufactured in and Exported from the U.S.: Is "Yes"
Primary Completion Date: On or after January 2008 or not specified, or
Study Completion Date: On or after January 2008, if Primary Completion Date not specified
Overall Recruitment Status: Not Withdrawn
Study Start Date: On or after January 18, 2017

Table 4: FDAAA 801 Problems

FDAAA 801 Problem
FDAAA 801 Problem	Solution
Missing FDAAA Information The record is missing one or more data elements required by FDAAA 801 (Responsible Party, Study Start Date, Primary Completion Date, and/or Primary Outcome Measure).	Record Owner: Review the record and modify it as needed, ensuring that all WARNING messages have been resolved. Select Entry Complete. Administrator/Responsible Party: Review and edit as needed. Select Approve and Release to submit the record to ClinicalTrials.gov for PRS Review (see Section 5: Preparing, Approving, and Releasing a Study Record to PRS).
Late Results—per FDAAA The record appears to be overdue for results submission per FDAAA 801 or 42 CFR Part 11.	Administrator/Responsible Party: Determine whether: Results are required to be submitted; or It is appropriate to submit a Certification or Extension Request to delay results submission. For more information, read When Do I Need to Register and Submit Results? Identify the appropriate individual within the organization to enter results information for the study. If necessary, create a User account for the individual and change record ownership (or update the record's Access List). If You Are Ready to Report Results Record Owner: If submitting results information for the first time, refer to the Results Data Entry from the Help section of the PRS main menu for the full set of instructional resources. Enter results information using the Enter Results link on the Record Summary page. Select Entry Complete. Administrator/Responsible Party: Review and edit as needed. Select Approve and Release to submit the record to ClinicalTrials.gov for PRS Review (see Section 5: Preparing, Approving, and Releasing a Study Record to PRS). To Request Certification or an Extension Administrator/Responsible Party: Identify the appropriate individual within the organization to enter a Certification or Extension Request. If necessary, create a User account and change record ownership (or update the record's Access List). Record Owner: Enter Certification or Extension information using the Delay Results link on the Record Summary page. Select Entry Complete. Administrator/Responsible Party: Review and edit as needed. Select Approve and Release to submit the record to ClinicalTrials.gov for PRS Review (see Section 5: Preparing, Approving, and Releasing a Study Record to PRS). Note: This problem will continue to be listed for the record until results information is submitted for PRS Review.
Incomplete Results—per FDAAA The record appears to be missing secondary outcome measure results information per FDAAA 801 or 42 CFR Part 11.	Administrator/Responsible Party: Identify the appropriate individual within the organization to enter results information for the study. If necessary, create a User account for the individual and change record ownership (or update the record's Access List). If You Are Ready to Enter Additional Results Information Record Owner: Enter additional results information by opening the Results Section from the Record Summary page and opening the relevant module that needs updating. Select Entry Complete. Administrator/Responsible Party: Review and edit as needed. Select Approve and Release to submit the record to ClinicalTrials.gov for PRS Review (see Section 5: Preparing, Approving, and Releasing a Study Record to PRS). Note: This problem will continue to be listed for the record until all secondary outcome measure results information has been submitted for PRS Review.

PRS Administrator Problems

Some problems on records can be resolved only by an Administrator, although the Record Owner may need to get involved, too. These PRS Administrator Problems are described in the following table.

Table 5: PRS Administrator Problems

PRS ADMIN Problem
PRS ADMIN Problem	Solution
Ready for Review and Approval A user has marked a record as Entry Complete following the initial data entry or modification of the record. The record is ready to be approved and released for PRS Staff review and to be made public on the ClinicalTrials.gov website.	Administrator/Responsible Party: Review and edit as needed. Select Approve and Release to submit the record to ClinicalTrials.gov for PRS Review (see Section 5: Preparing, Approving, and Releasing a Study Record to PRS).
Never Released A record has been created, but has never been released. A record must be marked as completed, approved, and released before it can be reviewed by PRS Staff and made public (or updated) on the ClinicalTrials.gov website.	Administrator/Responsible Party: Determine whether the study should be posted on ClinicalTrials.gov and who should finish data entry. Change record ownership or update the record Access List, if necessary. Record Owner: Finish initial data entry or update the record, as appropriate. Select Entry Complete. Administrator/Responsible Party: Review and edit as needed. Select Approve and Release to submit the record to ClinicalTrials.gov for PRS Review (see Section 5: Preparing, Approving, and Releasing a Study Record to PRS). Note: If the study does not need to be registered and posted on ClinicalTrials.gov, and the record has never been Released, delete the record (see Section 7.6: Deleting a Record or Results Section)
Update Not Released A record that has been posted on ClinicalTrials.gov has been updated, but the update has not been released. A record must be marked as completed, approved, and released before it can be reviewed by PRS Staff and made public (or updated) on the ClinicalTrials.gov website.	Administrator/Responsible Party: Determine who should finish updating the record. Change record ownership or update the record Access List, if necessary. Record Owner: Review and update the record, as appropriate. Select Entry Complete. Administrator/Responsible Party: Review and edit as needed. Select Approve and Release to submit the record to ClinicalTrials.gov for PRS Review (see Section 5: Preparing, Approving, and Releasing a Study Record to PRS).

Section 9

Record Upload / Download

Study data may be uploaded into the PRS from other sources, rather than entered manually. This section describes the two methods available: uploading from the National Cancer Institute's Clinical Trial Registration Program (NCI CTRP) and uploading XML-formatted data from the Sponsor Organization's computer system. While most organizations will not need either of these capabilities, some may find it convenient to avoid rekeying (especially if they have large quantities of information to enter into the PRS at one time).

NCI CTRP Upload

If a study has been registered in NCI CTRP, the associated protocol information can be uploaded directly into the PRS. This service prevents users from having to enter study information in both systems, but must be used carefully and consistently to avoid errors and data loss.

The Upload Option service poses a significant risk of accidental data loss and thus should be used carefully. After a PRS record has been created via Upload from CTRP, choose one of the following approaches for updates and use it consistently:
- Make all updates in the PRS.
- Update protocol information solely via Upload from CTRP. All protocol modifications must be made in the CTRP first, and then copied into the PRS via Upload from CTRP using the Overwrite Protocol option. Do not make changes to Protocol Section in the PRS, as they will be lost when the next upload occurs.
- Update location information solely via Upload from CTRP. Locations are updated via Upload from CTRP using the Overwrite Locations option. Other than Location information, changes to the Protocol Section must be made in the PRS. Do not make changes to Location information in the PRS, as they will be lost when the next upload occurs.
To use this function, follow these steps:
1. Select Upload from CTRP from the Records section of the PRS main menu.
2. Fill out the following fields on the Upload Protocol Information from CTRP form:
  - NCI Record ID: Enter the NCI assigned identifier for the trial, in the form NCI-yyyy-nnnnn, where yyyy is the year and nnnnn is a 5-digit number.
  - Unique Protocol ID: This ID must match the Lead Organization Trial Identifier specified in CTRP. For new records, the ID cannot match the Unique Protocol ID of any existing PRS records. When overwriting protocol or location information, the ID must match the Unique Protocol ID of the PRS record to be updated.
  - Upload Option: Select the upload option to:
  - Create a new PRS record.
  - Overwrite protocol in existing PRS record.
  - Overwrite locations in existing PRS record.
  With any of these methods, Results information must be entered and maintained in the PRS. Upload from CTRP does not affect Results Section information.
3. Enter CTRP Username/Password: Enter the same username (email address) and password that you use to log directly into the CTRP system at trials.nci.nih.gov. This username/password must be from NCI/CTRP, not from the PRS. If you have forgotten your CTRP username or password, or need other assistance regarding CTRP system access, contact CTRP_Support@mail.nih.gov.
4. Select Analyze.
Following successful Upload from CTRP, you must select Entry Complete, Approve, and Release in the PRS to submit the record for review by PRS Staff before it can be made public on the ClinicalTrials.gov website.
XML Upload

The XML file transfer (upload) capability facilitates the transfer of data into ClinicalTrials.gov from your computer system. This capability is available for those organizations that already have a database containing the necessary information and the significant technical expertise required to structure the data according to the PRS XML schemas.

XML files may contain protocol information, results information, or both. They are subject to the same validation process as records created using the PRS web interface.

To access detailed documentation for the PRS XML Schemas, select Upload Record (XML) from the Records section of the PRS main menu or see the XML Schemas page.

Multiple records can be uploaded from a single file by concatenating the XML for the records (that is, linking them together in a chain) and placing the concatenated XML within a "<study_collection>" tag.

Once the XML file is prepared, select Upload Record (XML) from the Records section of the PRS main menu and follow the instructions provided.

Administrators can select Batch Record Upload (XML) from the Records section of the PRS main menu to upload XML files for multiple records.
XML Download

Data from one or more records, including available results, can be downloaded from the PRS into an XML file on your computer. To download a single file, open the record and use the Download XML link on the Record Summary page.

Administrators can download all XML records from their organization into a single XML file by selecting Batch Record Download (XML) from the Records section of the PRS main menu.

Section 10

PRS Application Program Interface

The ClinicalTrials.gov PRS provides an Application Program Interface (API) for those organizations with sufficient computer systems and technical support.

External Upload: Upload XML for a Single Record

The External Upload service provides an API for uploading XML for a single record into the PRS. It is recommended that an organization become proficient with the interactive XML upload mechanism before attempting to use this interface.

Request

The Service is invoked by sending a single HTTPS POST request to
[PRS URL]/prs/app/action/ExternalUpload
with the following parameters:

orgName
userName
passWord
uploadXML
autoRelease

The first three are the same credentials used to login to the PRS. The uploadXML parameter should contain XML in the same format used for files uploaded interactively.

The same protocol and results XML schemas for interactive XML upload (accessible via the PRS Upload Record page) apply to the External Upload API, with the limitation that only one record may be uploaded at a time via the API.

Set the autoRelease parameter to "true" to affect an automatic Release of the record after upload. The record must be error-free in order to be Released.

Response

The response is sent as XML using UTF-8 encoding. The response includes overall status of the upload operation:

NEW_STUDY
CHANGED_STUDY
UNCHANGED_STUDY
ERROR

For the new, changed or unchanged cases, a list of record validation/status messages is included. These messages correspond to the contents of a Batch Summary Report for interactive uploads.

For the error case, a failure message is included. This message is designed to be displayed directly to the user on the client system.

Example: Successful Upload Response

        <externalUploadReport>
                        <uploadStatus>CHANGED_STUDY</uploadStatus>
                        <validationMessages>
                                <validationMessage>
                                        <severity>ERROR</severity>
                                        <source>idInfo.secondaryIds[0].id</source>
                                        <message>Secondary ID is a required field.</message>
                                </validationMessage>
                                <validationMessage>
                                        <severity>WARNING</severity>
                                        <source>sponsorInfo.responsibleParty.responsiblePartyType</source>
                                        <message>Responsible Party has not been entered.</message>
                                </validationMessage>
                                <validationMessage>
                                        <severity>NOTE</severity>
                                        <source>detailedDescription</source>
                                        <message>Detailed Description: data not entered.</message>
                                </validationMessage>
                        </validationMessages>
             </externalUploadReport>

Example: Failed Upload Response

             <externalUploadReport>
                              <uploadStatus>ERROR</uploadStatus>
                              <failureMessage>Invalid PRS login information.</failureMessage>
             </externalUploadReport>

Certain problems, such as missing input parameters in the request, result in a 400 status code instead of the XML response.

External Download: Download XML for a Single Record

The External Download service provides an API for downloading XML for a single record from the PRS. It is recommended that an organization become proficient with the interactive XML upload and download functions before attempting to use this interface.

Request

The Service is invoked by sending a single HTTPS POST request to
[PRS URL]/prs/app/action/ExternalDownload
with the following parameters:
- orgName
- userName
- passWord
- orgStudyId
The first three are the same credentials used to login to the PRS. The orgStudyId parameter is the identifier labeled as Organization's Unique Protocol ID in the PRS.

The same protocol and results XML schemas for interactive XML upload (accessible via the PRS Upload Record page) apply to the External Download API, with the limitation that only one record may be downloaded at a time via the API.

Response

The response is sent as XML using UTF-8 encoding. For a valid request the response is the XML for the record.

If the download does not succeed, an XML response including a failure message is returned. The failure message is designed to be displayed directly to the user on the client system.

Example: Failed Download Response
```
            <externalDownloadError>
                          <failureMessage>Invalid PRS login information.</failureMessage>
            </externalDownloadError>
```
Certain problems, such as missing input parameters in the request, result in a 400 status code instead of the XML response.
Record Information Download: Obtain Summary and Status Information

The Record Information Download service provides an API for downloading XML with record summary and status information from the PRS Home page record list, the Public Site Report, the Planning Report and the PRS Review Comments List page. It is recommended that an organization become familiar with the PRS web interface and the content of these pages before attempting to use this API.

Request

The Service is invoked by sending a single HTTPS POST request to
[PRS URL]/prs/app/action/RecordInfoDownload
with the following parameters:
- orgName
- userName
- passWord
These parameters are the same credentials used to login to the PRS. The corresponding account must have Administrator access level.

Response

The response is sent as XML using UTF-8 encoding. For a valid request the response is the record information XML for all records in the specified Administrator's organization account. For details on the structure of record information XML see the Record Information XML Schema in the PRS.

If the download does not succeed, an XML response including a failure message is returned. The failure message is designed to be displayed directly to the user on the client system.

Example: Failed Record Information Download Response
```
            <recordInfoDownloadError>
                          <failureMessage>Invalid PRS login information.</failureMessage>
            </recordInfoDownloadError>
```
Certain problems, such as missing input parameters in the request, result in a 400 status code instead of the XML response.

Section 11

Terms and Conditions

Organizations and individuals submitting information to the PRS must agree to the following Terms and Conditions:

Only studies that conform to applicable human subjects or ethics review regulations (or equivalent) and applicable regulations of the national (or regional) health authority (or equivalent) may be submitted.
Notice of changes in recruitment status must be provided as soon as possible, but no later than 30 days after such changes. All other submitted information must be reviewed, verified, and updated as necessary and no less than every 12 months.
The submitting organization, or individual designated as the Responsible Party, is responsible for the completeness and accuracy of the information submitted to the PRS.
Study information must be submitted in English.
Multiple groups within a single entity (for example, a company, university, government agency) must share a single PRS organization account.
Previous versions of study information will be available to the public, although the default view will be the most recent version.

Introduction

Record Basics: Steps to Posting a Study Record on ClinicalTrials.gov

Description of Protocol Registration and Results System WorkfloW

Log in to PRS

Create a new record

Enter (or edit) study information

Submit the study record for PRS Review

PRS Staff review the record

Record is registered and posted

Keep record up to date

Add results

Record status

Accounts

Overview: Roles and Responsibilities

Determining Who Should Submit a Record

Applying for an Account

Check the current list of organizations with a PRS account to see if the Sponsor Organization is on the list.

Once the Sponsor Organization appears on the list of organizations with a PRS account, you can submit a request to the PRS Administrator to request a user login.

Changing User Account Information

Update/Modify User Information

Change Password

Find Administrator Information

Administrator Functions

Create New User Account

Update/Modify User Account Information

Change User Password

Disable/Enable User Account

Maintaining Organization Accounts

Manage Groups

List Email Addresses

Lookup User

Product Information

Reports (Administrators Only)

Planning Report

Public Site Report

Record Information Download

Review History Download

Creating a New Record and Entering Data

How to Create a New Record

New Record

Enter the Unique Protocol ID, Brief Title, and Study Type

Click Continue

Repeat data entry and click Continue for each module

Click Continue and then Quit on the next module

Follow instructions in Section 5

Data Entry Tips

Formatting Text

Formatting Eligibility Criteria

Special Characters

Optional versus Required Fields

System Validation Messages: Errors, Warnings, Notes

Record Access List

Preparing, Approving, and Releasing a Study Record to PRS

Data Entry Review

Draft Receipt

Preview

Spelling and Acronym Checkers

PRS Review Criteria

Approving a Record

How to Submit a Record for Approval

How to Approve a Record for Release to PRS

Releasing a Record

Batch Release

Check Batch Release Status

Receipts and Past Releases

Requesting a Receipt

Viewing Past Releases

PRS Review Process

Identifying Records with PRS Review Comments

View PRS Review Comments

Editing a Record with PRS Review Comments

Updating and Maintaining Records

Modifying a Record

Edit All: Module Walk-Through

Edit a Module

Contact Users

Changing Record Owner (Administrators Only)

Transferring a Record to/from a Different Organization

Copying a Record (Administrators Only)

Deleting a Record or Results Section