Clinical Trials Protocol Registration System (PRS) Instructions

Dear User (principal investigator):
The National Institute of Diabetes and Digestive and Kidney Diseases has adopted the National Library of Medicine’s Clinical Trials Protocol Registration System (PRS) to enter clinical trial records into ClinicalTrials.gov. ClinicalTrials.gov provides patients, family members, and members of the public current information about clinical research studies. You will need to use the PRS to create new records and to modify existing records. Your NIDDK program official has created an account under your name to enter the PRS. You should have received or will soon receive an automated e-mail providing you with login information. Upon completing or updating a record, the NIDDK program official will review and approve the record for ClinicalTrials.gov. Below is a short step by step guide for users of NIDDK sponsored trials. A Reference guide for the PRS can be found at http://prsinfo.clinicaltrials.gov. Do not apply for an NIDDK account. You already have one.

PROCEDURES FOR USERS
In the National Library of Medicine’s Clinical Trials Protocol Registration System you may:

1. Log-in to the NLM Clinical Trials Protocol Registration System.
2. Enter Clinical Trial information.
3. Modify a record.
4. View a record.
5. Preview a record as a Clinicaltrials.gov Web page.
6. Complete and submit the trial for approval by NIDDK
7. Delete a record.
8. Change your password.

Log-in to the NLM Clinical Trials Protocol Registration System

1.Click on to Log-in to the National Library of Medicine’s Clinical Trials Protocol Registration System (PRS).
2. Complete the three fields for logging into the site:

a. Organization: niddk_ddn or niddk_dem or niddk_kuh
b. User name: user log-in name (Last name, first initial)
c. Password: niddk1 (case-sensitive)

3. You should now be at the Main Menu of the PRS.
4. To Log-out of the PRS, select the Log-out link from the Main Menu screen.

1. Click on Create from the Main Menu.
2. Enter the Unique Protocol ID and Brief Title for the Record on the Create New Protocol Record screen. Your NIDDK program officer will provide you with a suggested Unique Protocol ID and Brief Title.
3. Click the Continue button to save the information. This action also creates the record under the Unique Protocol ID.
4. Enter information into each data entry screen.
5. Click Continue to save information and move to the next screen.
6. Click Quit to stop data entry, then click Save Study to save information, or Delete Study to delete the information. You may leave and save data entry and return to it at any time.

1. The data entry screens contain text boxes, radio buttons, pull down menus, and other tools to facilitate data entry.
2. Data screens are clustered by general topic for each CT. These clusters include: Title, Sponsor, Summary, Status, Design, Interventions, Conditions, Eligibility, Locations, Citations, Links.
3. Complete each field using the various data entry methods. All fields can be modified at a later date if you do not have the needed information at hand.
4. Field definitions and examples can be viewed by clicking on the links associated with each field name.
5. To format large blocks of text into paragraphs, press Enter twice between paragraphs.
6. To format bulleted lists of text, indent four spaces, enter an asterisk or hyphen, followed by a space, and then the text, followed by one Enter.
7. The Conditions field requires the user to access a subject headings browser to enter standard terms. If you cannot find the terms, or choose not to use the browser, please enter the terms in the Keyword field.

1. Click on Modify from the Main Menu screen.
2. Set the desired viewing options and click OK.
3. Click on the Edit link to the left of the record you wish to edit to go to the Edit Protocol Record screen.
4. Find the data field to be modified and click on the Edit link to the left of the field cluster.
5. After completing the edits of a field, click the OK button to save the edits and return to the Edit Protocol Record.
6. Update the Verification Date on the fifth field cluster from the top.

1. Click on View from the Main Menu screen.
2. Set the desired viewing options in the Protocol Record Selection Criteria screen and click OK.
3. Click on the View link to the left of the record you wish to view.
4. View the record. The View Protocol screen is read-only. You must choose Edit from the Main Menu screen to modify record information.

1. Click on Modify from the Main Menu screen.
2. In the Edit Protocol Record screen, click on the Edit link to the left of the record you wish to view.
3. Click on the Preview link.
4. Preview the record. Click on the Continue link to return to the Edit Protocol Record screen.

1. After completing the last data entry screen (Links), click Continue to bring up the Study Completed screen.
2. Click OK to activate the automatic PRS data validation process.
3. Make all the required changes based on the messages after each data field: ERROR messages MUST be corrected. The record will not be released to the Internet database until the error is resolved.
NOTE messages should be reviewed. The record can be released to the Internet database with a Note.
4. After all desired information has been entered about a record, AND there are NO Errors, In the Edit Protocol Record screen, above the Edit fields, click Change status.
5. Click the Completed check box on the screen and type any comments in the text area that you wish the Administrator to read when reviewing the record.
6. Click OK to save the status change (this will generate an email to the Administrator), or Cancel to retain the original status.

1. If a previously completed record has been modified, click Change status in the Edit Protocol Record screen.
2. Add or delete comments, click the Completed check box, and click OK. An e-mail alerting the NIDDK administrator of changes will be sent only if the Completed check box is changed. Repeat: The entry in the completed check box must be changed (either checked or unchecked) to alert the administrator that a change has been made.

1. Click on Modify from the Main Menu screen.
2. Click on the Edit link to the left of the record you wish to delete.
3. Click on the Delete link.
4. Click the OK button on the Delete Protocol screen to delete the record, or click Cancel to return to the Edit Protocol Record screen without deleting the record.

1. Click on Change Password from the Main Menu screen.
2. Enter:
Your old password
Your new password
Your new password again for verification

3. Click the Change Password button to save the new password, or click Cancel to retain the old password.


*Contact the your NIDDK administrator if you have forgotten or lost your password. The Administrator will give you a new password, which should then be changed to a more personal password.