Protocol Review, Assistance, and Routing
TRI Portal Facilitators review all human subject research protocols submitted in CLinicAl Research Administrator (CLARA), a web-based portal for submission, review, approval and tracking of human subjects research. A Portal Facilitator reviews each submission to ensure the presence of basic elements and consistency throughout each document as well as determine routing of the protocol to which, if any, regulatory oversight committees for review. The Portal Facilitator provides feedback to investigators, as necessary, prior to moving it forward to the Institutional Review Board (IRB) and other regulatory oversight committees. This allows investigators to make necessary changes prior to IRB review and limits the number of IRB contingencies, speeding up the process for final IRB approval.
Upon request, the Portal Facilitator also assists faculty investigators with developing high-quality research protocols. To avoid delays in Portal Facilitator assistance, it is recommended investigators use the variety of tools and customizable templates provided below to develop their protocol prior to requesting Portal Facilitator assistance with protocols. Once the protocol is submitted and a protocol review is complete, the Portal Facilitator will work with investigators to make the recommended changes. The Portal Facilitator will also provide a more detailed review of the submission checking for coherence of objectives, design, and methodology.
After the submission has been reviewed by the Portal Facilitator and any recommended changes have been made, the Portal Facilitator will route the submission to the appropriate regulatory committees. These committees may include the Office of Research Regulatory Affairs, Budget Review, Legal Review, Conflict of Interest, Biosafety, Radiation Safety, PRMC, and Clinical Trials. A flowchart indicating how a submission maneuvers through the CLARA process is provided below.
Study Submission Tools and Templates
- Basic Human Subjects Research Protocol Template
- Detailed Clinical Trial Protocol Template
- Online Tool for Assessing Readability Level
- CLARA Processes Flowchart
- Frequently Asked Questions (FAQs)
- Plain Language Informed Consent Template
- HIPAA Authorization Form