As a research project is ongoing at Duke, it is the responsibility of the research team or PI to monitor and document study activities to ensure that, while active, the study is well-managed and maintains its institutional approval. This includes:
- Alerting appropriate parties to changes in the protocol or project
- Submitting required progress reports and renewals
- Implementing a plan for periodic checks of study data and research documentation
Study-level documentation and regulatory binders
Study-level documentation, whether on paper or electronic, enables research teams to organize essential study documents such as lab certifications, ethical approvals, communication with sponsors/funders, data agreements, and personnel (or delegation of authority) logs. In clinical research, this documentation is often referred to as a “regulatory binder”, and can be accessed by monitors, the IRB, and other regulatory bodies for reviews and audits. Protocols reviewed through the DUHS IRB are subject to study level documentation as specified by the Clinical Quality Management Program. Maintenance of a study's essential documents align with Good Clinical Practice and the principles of responsible conduct of research.
While documentation of this type is required for sponsored clinical research, it is also valuable for other (i.e., Campus IRB) human participant research and animal studies.
Management of study data
Throughout the project, it is important to conduct periodic checks of the data to ensure collection methods are accurate and data is appropriately captured, as well as to determine if data is being stored, cleaned, and curated as intended. Appropriate management of data requires that it is in accordance with institutional, sponsor, or federal guidelines, and is in alignment with the project data management plan and/or Research Data Storage Plan. Access the Collect, manage, and analyze data page for more information about appropriate data collection and management.
Protocol amendments and renewals
Protocol amendments must be submitted to the Campus IRB, DUHS IRB, IACUC, or IBC for any proposed changes to approved research protocols. The proposed revised activities cannot begin until approval is obtained from the regulatory body.
- For Campus IRB protocols, submit an amendment request form along with a copy of the approved protocol with the proposed amendments in track changes.
- For DUHS IRB protocols, amendments must be submitted through iRIS in accordance with the policy on protocol amendments.
- For IACUC approved protocols, submit the appropriate protocol amendment form.
- For IBC approved protocols, submit the appropriate documents.
To keep a protocol active and in compliance from a regulatory perspective, a continuing renewal must be submitted and approved prior to expiration, for Campus IRB, DUHS IRB, and IACUC protocols.
- For Campus IRB protocols, a Periodic Check-In Form must be submitted annually for the IRB to review and renew the protocol. For more information about continuing reviews and post-approval monitoring, access the Campus IRB website.
- For DUHS IRB protocols, a continuing renewal must be submitted in iRIS 60 to 45 days prior to the protocol expiration date. Access the DUHS IRB website for more information about continuing reviews and protocol expirations. Key personnel can use the IRB tab of myPortfolio in myRESEARCHhome to track expiration dates.
- For IACUC protocols, annual reviews are required for all previously approved, ongoing IACUC protocols that indicate use of a USDA regulated species or are supported with VA funds. Access the IACUC continuing review protocol guidance for more information.
Outside of Duke’s institutional requirements such as continuing renewals, there may be other necessary annual or as-needed reports or disclosures to the sponsor or funder. Access the Submit reports and disclosures, and communicate with sponsors page for additional information.
Handling expected or unexpected changes
A research study may encounter challenges including low participant recruitment, evolving technologies, or modifications with animal colonies.
- When to alert someone?
- If the change may have staffing or budget implications, the project grants and contracts administrator should be alerted as soon as possible.
- If the change might affect the population or procedures associated with human participant research, consult with the IRB to submit an amendment or determine next steps.
- If the change involves animal procedures, animal numbers, or other modifications to animal protocols, it may require an amendment. Consult with OAWA to determine the proper route.
- In instances when the change or update involves an outside entity, the researcher may need to:
- Update their Conflict of Interest Form
- Revisit contracts or agreements that should be in place
- Communicating to sponsor
- If the change is an administrative or financial management issue (such as carryover requests or changes to detailed budget requirements), the grants and contracts administrator should be notified to escalate the issue or request to the appropriate central office. Investigators should not contact the sponsor directly for administrative or financial issues. Access the Faculty Communication to External Sponsors on Administrative Issues policy for more information.
- If the change is scientific or programmatic, investigators may contact a program official directly for guidance or feedback.
Managing personnel additions and departures
Staff, faculty and other research team members can be added to protocols in both the Duke Health and Campus IRBs. In the case of additions, ensure that new personnel have completed the necessary training requirements before starting the process of the personnel change with the appropriate IRB. If personnel will have new roles on clinical research projects, ensure that they have appropriate DUHS human subjects protection and Oncore training to carry out their duties.
The IRB personnel change and Oncore updates may not be the only steps that must be taken. Ensure that other documentation (e.g., data use agreements, data provider permissions, etc.) and file access (e.g., Box, shared drives, etc.) are considered.
If the PI plans to leave Duke while a project is ongoing, steps need to be taken to transfer the protocol to a new PI at Duke or approvals and agreements may be needed to transfer the project to a new institution. Access the Close out the project page for additional information about transferring a protocol. Considerations for data use and transfers. Similarly, agreements and adjustments to the IRB protocol may be needed if an internal key personnel member will be leaving Duke but will remain involved in the project.
Utilize these checklists for considerations about data use and transfers: