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Registry Holder Information

Introduction

To submit a new patient registry profile or update an existing listing in the Registry of Patient Registries (RoPR) it is necessary to have an account on the National Library of Medicine's Protocol Registration System (PRS). The RoPR Registration System (RRS), sponsored by the Agency for Healthcare Research and Quality, is accessed via a record that is defined in PRS as a patient registry. Once RRS has been accessed, a user can manage data in either system. This document describes steps for managing data in PRS and RRS, and is intended for users that are not already familiar with these systems.

If the user is familiar with managing data in PRS but is new to the RoPR advance to Registry of Patient Registries (RoPR) Registration System (RRS).

ClinicalTrials.gov Protocol Registration System (PRS)

PRS Structure

PRS is structured by section. Complete each section appropriately, noting that required fields are indicated with a red asterisk (*). Fields marked with FDAAA are subject to the FDA Amendment Act of 2007, which primarily apply to Phase 2-3 clinical studies and may have less relevance for patient registries.

The sections of the PRS record include:

  • Title
  • FDA
  • Oversight
  • Sponsor
  • Summary
  • Status
  • Design
  • Interventions
  • Conditions
  • Eligibility
  • Locations
  • Citations
  • Links

For a new record, the user progresses through the sections via a Continue button. For existing records, an Edit link for the sections allows access to the appropriate content.

Within this guide all PRS field names will be described in blue bold underlined font (e.g., Study Type), reflecting their appearance in PRS. Within PRS, these field names act as hyperlinks which open a data element definition for that field.

PRS Data Validation

PRS displays error and other messages for various issues with the data, including the following:

Error Icon

Indicates serious problems that need to be addressed. Records with Errors cannot be released and published to the ClinicalTrials.gov Web site.

Alert Icon

Indicates problems that need to be addressed. Note: If IND/IDE Protocol? is No, then Alerts behave as if they are Errors, and the record cannot be released and published to the ClinicalTrials.gov Web site.

Warning Icon

Highlights data elements which are expected, but may not be required, for releasing and publishing the record to the ClinicalTrials.gov Web site.

Note Icon

Indicates potential problems that should be reviewed and corrected as necessary.

A record with error conditions (including Alerts in some cases) cannot be published to the ClinicalTrials.gov Web site.

Managing a Record in PRS

Step 1:

Log in to PRS (https://register.clinicaltrials.gov/)

Screenshot of the login page

Step 2:

From the Main Menu select Create (if managing a new record) or Modify (if managing an existing record).

Screenshot of the main menu page

Step 3:

In the Title section select Observational for Study Type. Then click the checkbox for Patient Registry. This selection will enable Patient Registry-specific fields later in the record management process, including the link to the RoPR Registration System (RRS).

Screenshot of the page where you select Observational for study type

Step 4:

Continue to populate the record up to the Design page. Under Design, populate all fields as required or applicable for the registry.

Use the Additional Registry Data link to access the RoPR Registration System (RRS). RRS will launch in a new browser window so you can continue to manage the data either in PRS or RRS.

Screenshot of Design page which links to the Registry of patient registries registration

Step 5:

Continue to populate the remaining sections from Interventions through Locations, and optionally Citations and/or Links.

Step 6:

On the Locations page, indicate the Central Point of Contact. If Overall Recruitment Status is "Recruiting," additional locations data for each site are expected. Click the Add a location link and populate all required fields for each location.

Step 7:

After entering all data and verifying that no Error or Alerts display, review the data for accuracy and thoroughness. Use the Edit links to make any corrections as necessary, then click the Complete link at the top of the page. Optionally, click the Preview link in the top menu to review the record as it will appear in ClinicalTrials.gov.

Screenshot of how to complete registration and navigate to the subsequent RoPR Registration System

Upon clicking the Complete link, a pop-up will launch in a separate window. In the pop-up click the link to access the RoPR Registration System (RRS).

If you are an Administrator for your organization, additional options to Approve or Release the record will be available.

The National Library of Medicine will review the content and may ask for corrections. Otherwise, the record is made public on ClinicalTrials.gov typically within 3-5 business days.

Registry of Patient Registries (RoPR) Registration System (RRS)

RRS Structure

Data in RRS is managed across six sections. An Overview page of the sections prompts the user for their email address for administrative purposes, and features an upload section where the user can upload XML content for a Registry Profile.

Users complete each section as appropriate, noting that required fields are indicated with a red asterisk (*). The sections of the RRS record include:

  • Registry Description
  • Registry Classification and Purpose
  • Contact and Conditions of Access
  • Progress Report
  • Related Information
  • Outcome Measures and Common Data Elements

Navigation to the sections is accessible via the tabs along the left side of the screen or by using the Previous and Next buttons at the bottom of the screen. A summary table also acts as a link to the various data sections, and indicates the section completion - the summary table displays on the Overview and Save/Release Registry Profile screens. The progress of data completion, based on required fields, is also indicated in a bar at the top of the screen.

RRS Data Validation

In RRS, errors display in red font on the page. Error messaging will dynamically clear when the error condition is resolved. A Registry Profile with error conditions (including Alerts in some cases) cannot be published to the RoPR Search Web site.

Managing a Record in RRS

Step 1:

Populate all required fields and provide additional data as appropriate in the Registry Description and Registry Classification and Purpose pages.

Screenshot of the Registry Description page and associated fields Screenshot of the Registry Classification and Purpose page and associated fields

Step 2:

In the Contacts and Conditions of Access section, indicate (yes or no) whether the sponsor is interested in being contacted, then complete all additional required fields.

Note: Either E-mail or Phone is required if Interested in Being Contacted? is Yes. For E-mail, it is recommended to use a department or distribution list rather than an individual's address

Screenshot of the Contact and Conditions of Access Page and associated fields

Step 3:

In the Progress Report section, indicate (yes or no) if a Progress Report or any other update for the registry is available.

Upon clicking Yes, a new data group will display with the appropriate fields for a Progress Report. Complete all required fields and provide additional data as appropriate; click Save when the Progress Report is complete.

Use the Add Progress Report button to create additional Progress Reports, and use the Edit icon to modify them. A Progress Report can be deleted by clicking the Edit icon and then clicking the Delete button.

Screenshot of adding progress reports on the progress report page

Step 4:

In the Related Information section, indicate (yes or no) if any external Web sites for the registry exist.

On clicking Yes, a new data group will display with the appropriate fields for a Related Link. Complete all required fields and provide additional data as appropriate; click Save when the Related Link is complete.

Use the Add Related Link button to create additional external links, and use the Edit icon to modify them. A Related Link can be deleted by clicking the Edit icon and then clicking the Delete button.

Step 5:

In the Outcome Measures and Common Data Elements section, the Condition or Service of Interest for Registry page displays first. Select the disease, condition or service studied in the registry, then continue to the Category page and select any descriptors which apply to the registry.

Screenshot which shows the Outcome Measures and Common Data Elements page

Step 6:

Use the Preview page to review the Registry Profile as it will appear on the RoPR Search Web site. Use the Edit icon in the Section header or use the left navigation options to make any necessary corrections.

Screenshot of the preview page, for the viewing of all entered data

Step 7:

When the Registry Profile is complete, proceed to the Save / Release Registry Profile page. If all sections are complete and the record is ready for publishing to the RoPR Search site, click the confirmation check-box and then click the Release and Exit button. A pop-up will prompt for a final confirmation. After release, the Registry Profile will be available on RoPR Search within one calendar day.

Alternatively, Save and Exit will allow the user to save the record without releasing it for publication, and return to it later.

Screenshot of how to either release your registry or save and exit for completion later

Both the Release and Exit button and the Save and Exit button will terminate the RRS session. In order to make further updates to the Registry Profile, the user will need to log back in to PRS and access RRS as described above.

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