Manage study and maintain institutional approval

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 quality management reviews as specified by the Clinical Quality Management Program policy. Maintenance of a study's essential documents aligns with Good Clinical Practice and the principles of responsible conduct of research. 

Advarra Regulatory Management System (eReg) is a Part 11 compliant, electronic Regulatory Management System that allows regulatory coordinators to store protocol documents, track staff credentials and organizational regulatory documents, and share those documents between protocols. Staff can also manage INDs, SOPs, and participant-related documents within the system. eReg also allows for remote monitoring. For more information contact OnCore@duke.edu.

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. 

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 Duke Research Data Lifecycle (DRDL) Plan. Access the Collect, manage, and analyze data page for more information about appropriate data collection and management.

Protocol amendments to approved research protocols must be submitted to the Campus IRB, DUHS IRB, IACUC, or IBC. The proposed revisions cannot be instituted 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 the "myPortfolio" widget in myRESEARCHhome to track expiration dates.
• For IACUC protocols, reviews are required at least every 3 years. A protocol expiration date is assigned at the time of approval and the protocol must have a complete IACUC re-review and approval prior to the expiration date to continue the animal activity. Some funding may require annual reviews. Access the Protocol Management and Annual Review page 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.

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 grant manager 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.
    • Campus IRB
    • DUHS IRB
  • 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 grant manager should be notified to escalate the issue/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.

Changes

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, new personnel must 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, they must have appropriate DUHS  human participant 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.

All personnel that handle animals must be included on the appropriate Duke IACUC protocol prior to initiating animal work. New personnel must complete IACUC required training and clearance activities to be added to a protocol. New personnel can be added to a protocol by submitting an IACUC protocol amendment.

Departures

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 Offboarding page and the Close out the project page for additional information about transferring a protocol.