Please also reference the “How To Apply” section of the PCI portion of the GHUCCTS website, for further details on the SEPCOM application and review process.
The following documents are required to start the SEPCOM review process: full protocol, initial IRB application, IRB site supplement document (required for GU and MedStar), Investigator’s CV, and draft ICF.
For studies that are GHUCCTS-funded and/or will be utilizing more than one GHUCCTS’ institution, please submit your IRB application to GHUCCTS IRB. Please use this SEPCOM – GHUCCTS IRB review summary as a guide to this streamlined review process. Note that the SEPCOM review must occur prior to the GHUCCTS IRB review.
Once the complete study application is submitted, it will go to the SEPCOM for review. The source of study funding, as well as the study’s prior level of review, determines the type of review the Committee will carry out. Please see this reference grid for details.
Kathryn Turner can assist you if you have questions about clinical support services available from the CRU.
Once the complete study application is submitted, it will go to the SEPCOM for approval. If there are any concerns about the study, you will receive a contingency letter asking you to address the concerns prior to final approval.
You are ready to start accessing CRU resources once the study has received both IRB and SEPCOM approval.
You must schedule an initiation meeting with the CRU at 202-444-0726 to start your study. FDA GCP guidance states “The investigator should ensure that all persons assisting with the trial are adequately informed about the protocol, the investigational product(s), and their trial-related duties and functions.” ICH guidelines (Part 2.8 and 4.1.5) and GCP guidance (4.2.4). The CRU initiation meeting is held to train the CRU staff on protocol procedures and help study teams remain in compliance with these regulations. In addition, the initiation meeting is focused on the procedures requested of the CRU, ensuring clear understanding between study teams and the CRU on how and who will conduct study procedures with a focus on implementation at this site. You will be provided a copy of the CRU initiation meeting notes and staff sign-in sheet for your regulatory records.
Your study will be assigned a CRU primary clinical liaison. This CRU staff member will be your primary contact for your study. S/he will complete flowsheet development, which will be used to document the procedures conducted on the CRU and the protocol orders.