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.

NEW! Use the DRDL User Self-Service Portal to:

  •  Edit an approved DRDL
  •  Get access to the PDFs for a current DRDL and Plan
  •  Check the status of a DRDL
  •  Get a survey link to finish an incomplete DRDL
  •  Request a DRDL for a protocol that may have only an RDSP

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 other staff within the School of Medicine.

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

  • These PDFs can be uploaded into Oncore.

Study Team approves completed DRDL plan.  At the time of approval, the DRDL review is considered complete. The reviewer can update Oncore to move towards institutional approval. 

​​​​​​Annual reviews for studies requiring DUHS IRB continuing reviews. On an annual basis, the study team will receive an email with a copy of the DRDL responses and Feedback/Plan, and a link to a REDCap survey to complete the annual review. 

  • If there are no changes to the data or the plan, the study team will approve.
  • 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 transitioned from the RDSP to the DRDL.  

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 required a new DRDL.
  • May 31, 2023 - All RDSPs were  locked.  
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

Within 24 hours of a protocol being 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 or Oversight Organization 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 submit a request using the DRDL User Self-Service Portal.
  • 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 approved by the study team 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 SOM staff 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, SOM 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, use the DRDL User Self-Service Portal.