Duke Research Data Lifecycle (DRDL) Plan Guidance

The Duke Research Data Lifecycle (DRDL) plan is a required process for all projects submitted through the DUHS IRB.  The purpose of the DRDL is to ensure that study teams are storing, managing, and sharing their data in alignment with institutional and sponsor guidelines.  Additionally, it provides an avenue for support for projects that may involve technologies, security requirements, or other complexities. The DRDL replaces the Research Data Storage Plan, which was in use from 2011-2023.

If you are submitting DRDLs and have questions, please contact your CRU reviewer.  If you are a reviewer and you have questions, please reach out via the dedicated DRDL Microsoft Teams channel.

Basic DRDL Workflow

Team completes DRDL questions via the custom link sent via REDCap.  This link is sent to the study team the morning after the iRIS submission.

System determines if a review is needed

  • Projects with known solutions will likely not be reviewed;
  • Those that are more complex are likely to be reviewed

Review completed (if needed). This involves someone in your CRU/OO, who may also engage the OASIS team

​Team receives copy of their 1) DRDL responses and the 2) System or reviewer Feedback/DRDL plan.  

  • These PDFs can be uploaded into Oncore.

PI attests to the plan.  At the time of attestation, the DRDL review is considered complete. The reviewer can update Oncore to move towards institutional approval. 

​​​​​​Annual attestations. The PI will receive a copy of the DRDL responses and the DRDL Feedback/Plan on an annual basis.

  • If there are no changes to the data or the plan, the PI will attest. 
  • If there are changes, there will be an option to update the DRDL. 

DRDL Guidance

Transition from RDSP to DRDL

The Research Data Storage Plan (RDSP) has been a part of Duke's clinical research institutional approval process since 2011.  As of May, 2023, Duke will be transitioning from the RDSP to the DRDL.  Here are important considerations during the transition: 

Key dates

  • May 12, 2023 – Last day teams could submit a new RDSP in eGRC.  
  • May 24, 2023 – DRDL go-live.  New IRB submissions created on or after this date will require a new DRDL.
  • May 30, 2023 –
    • Date by which all pending RDSPs must be approved.  If they are not yet in an approved state, a new DRDL record will need to be created. 
    • All RDSPs should be exported by this date, and saved in Oncore (OnCore -  PC Console> Documents/Info Tab> Protocol attachments section) .  Please note that DOCR is investigating a way to do a bulk export to email to CRUs.  Stay tuned.
  • May 31, 2023
    • All RDSPs will be locked.  This is the last day you will be able to view or access RDSPs in eGRC.
  • June 1, 2023
    • The RDSP tab in eGRC will be removed.

FAQs

  • How do I get help during the transition?
    • Submitters should reach out to their CRU/OO reviewer who can seek assistance if needed.  Technical issues can be sent to drdl@duke.edu.
    • CRU reviewers should use the dedicated Teams channel to get help.
  • Can I access the RDSPs in eGRC, even just view only?
    • As of May 31, 2023, eGRC will be locked.  All teams are strongly encouraged to download all RDSPs prior to this date.
    • One June 1, 2023, the RDSP tab will be removed from eGRC and there will be no longer be an ability to access or view RDSPs.
Tools and tip sheets

Visit often, as new resources will be added frequently.  Tips sheets and resources for CRU/OO reviewers can be found in the Microsoft Teams Channel.

 

How to complete a DRDL

Once a protocol is submitted in iRIS, the research team will receive a link to complete the DRDL. Some information will be pre-populated from iRIS to save the team time. 

Once the submitter answers the DRDL questions, they will see one of two screens.

  • If the study does not require further review, the submitter will see a green box indicating Auto-Approval.  Below in grey, are summaries of the DRDL responses, followed by a blue box including additional other requirements or necessary steps. 
  • If the study does require additional review, the submitter will get screen with a red box.  This means that the DRDL is going to the CRU for review.

Other important information about completing a DRDL:

  • The link to complete the DRDL will go to the PI and study coordinator(s).  The link can be forwarded to others to complete the DRDL, but notifications about next steps will continue to go to the PI and coordinators.
  • Once the DRDL survey is completed, you cannot go back in and update.  If a change is required, please contact your CRU reviewer.
  • To save time, review the DRDL questions ahead of time.  
DRDL Reviews

If a DRDL requires review, it will be directed to your designated CRU/Oversight Organization reviewers.  They will contact you with questions about the project.  If they are reviewing, they may do one of three things:

  • They may be able to review your protocol and DRDL response and approve as-is. 
    • If this happens, the PI and the coordinator will receive a copy of the DRDL responses and the DRDL Plan.  This serves as the plan that should be followed for data management.
    • The CRU reviewer will mark the DRDL as approved in Oncore (using the date the DRDL was signed by the PI as the "approval date") and the study can proceed towards institutional approval
  • They may reach out to you for additional clarification or questions.  The CRU reviewer may be able to then create a custom plan, which they will document in your DRDL
    • If this happens, the PI and the coordinator will receive a copy of the DRDL responses and the DRDL Plan, which contains custom plans from the reviewer. This document serves as the plan that should be followed for data management.
    • The CRU reviewer will mark the DRDL as approved in Oncore and the study can proceed towards institutional approval
  • The CRU may need to coordinate with the OASIS team to involve other research support entities (Information Security, Contracts, Privacy, etc.).  It is likely that the research team will be involved in these reviews.  In this case, OASIS and your CRU are working towards a custom plan, which they will document in your DRDL
    • If this happens, once a solution is determined, the PI and the coordinator will receive a copy of the DRDL responses and the DRDL Plan, which contains custom plans from the reviewer.
    • The CRU reviewer will mark the DRDL as approved in Oncore (using the date the DRDL was signed by the PI as the "approval date") and the study can proceed towards institutional approval

Reviewers have their own support page on the DRDL Microsoft Teams team.

Updating or retrieving a DRDL

If a study team needs to retrieve or update their DRDL, the best contact will be the CRU/OO reviewer.  In addition, research teams will be prompted annually to review the DRDL.  At this time, they will have the ability to update the DRDL.  If there are no changes, they will simply attest to the existing DRDL.