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RDCRN Protocol Database website

RDCRN Protocol Database website

The RDCRN Protocol Database website is accessible to all RDCRN members at https://protocols.rarediseasesnetwork.org/. This website contains basic information about all RDCRN Protocols. The information collected in this website is used for creating reports as well as to display on public RDCRN websites (such as https://www.rarediseasesnetwork.org and consortium websites) so it is critical to keep this information correct and up-to-date.

All RDCRN members can search, filter and view all Protocols. Clicking the Name will open a Details page displaying more information about the Protocol. Select Consortia members (typically the Consortium PM & PI) will see an Edit button which will allow them to make changes to some fields. Anyone may use the Request Changes button to create a Help Desk ticket.

Field details

  1. Consortium

    1. Each Protocol is associated to one RDCRN Consortium.

  2. Protocol Number

    1. A protocol will be assigned a unique 4 digit RDCRN number. Once assigned this number cannot be changed.

  3. Alternate ID

    1. If the protocol has been assigned a number by the IRB, other governing body, or the NIH; please enter it here.

  4. Grant Project Number(s)

    1. The project number in the RDCRN U54 grant application that this protocol falls under.

  5. Title

    1. Full name/title of the protocol

  6. Short Title

    1. If the protocol is referred to using a shortened version of the title, or an abbreviation, it may be entered here.

  7. Status

    1. Determines whether the protocol should be showed to the public on the Network and Consortia websites. Active studies show on the websites, Inactive studies do not show on the websites at all. This field is independent of what is set in the Study Status and Enrollment status fields.

  8. Is this a pilot project? and Is this an early career project?

    1. Used for reporting and categorizing protocols

  9. Early career project duration

    1. Use this field if the protocol is an early career project. Describe project duration such as "1 Year".

  10. Diseases studied

    1. List of one or more RDCRN diseases that are associated to the protocol

  11. Research types

    1. Select all that apply

  12. Funding type

    1. By default this is set to ‘RDCRN’. If the study should show on the RDCRN website with a label of Third-party Collaboration, change to this value from RDCRN.

  13. Short description

    • Information inserted here will populate on the public website,

  14. Study status:

    1. High-level status of the study

      1. Start-up: Study is not yet active, but protocol number has been assigned. Details still being determined.

      2. Active: Change to Active from Start-up when study is changed to Enrollment status = Recruiting. Study may stay Active after it is Closed to Recruiting. For example, a study can still be Active while in an analysis phase after all enrollment is complete.

      3. Closed: IRB closure letter is complete.

      4. Cancelled: Protocol number was assigned, but Study did not get to the Active state.

  15. Enrollment status

    • Displays on the public Network and Consortia websites

      • Not Yet Recruiting

      • Recruiting

      • Closed to Recruiting

  16. Study population type

    1. Select Pediatric, Adult or Both pediatric and adult

  17. Initiation cycle

    1. Select the appropriate RDCRN cycle number

  18. Website url

    1. Link to the RDCRN Consortium website page where the protocol details are displayed

  19. Related documents url

    1. Link to the RDCRN Box folder where relevate documents are stored

  20. Florence record

    1. Indicate if a record for the protocol exists in the RDCRN Florence website

  21. IRB approval status

    1. Select Approved or Not Yet Approved

  22. First IRB approval date, Most recent IRB approval date and IRB closed date

    1. Enter the relevant date fields, if known

  23. Protocol sites

    1. Sites that have been associated to the protocol.

    2. Sites that were once active but are no longer active on the protocol are listed as Inactive and will not be displayed on the public RDCRN websites for this protocol.

  24. Current number of sites and enrollment information should be kept up to date on a quarterly basis.

  25. Protocol registered

    1. select Yes if the study is registered on ClinicalTrials.gov

  26. Clinical Trials Number

    1. Associated ClinicalTrials.gov number

  27. Treatment tested

    1. Select the best option if relevant

  28. Clinical Trials IND

    1. Investigational New Drug, select yes or no and populate ClinicalTrials IND, clarify:

  29. ClinicalTrials IDE:

    1. Investigational Device Exemption, select yes or no

  30. Trial put on clinical hold?

    1. Select yes or no