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New Trial Start-Up
Three Georgetown University offices are involved in the approval of your clinical trial and you should contact them simultaneously:
- IRB - Institutional Review Board Office
- Room SW104, Med-Dent Bldg
- 202-687-0328
- OSR- Office of Sponsored Research
- Room 1100, 3300 Whitehaven Street, NW
- 202-687-1701
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CTO - Clinical Trials Office
New Trial Start -Up
Step 1
Your first contact with a study sponsor about a new trial typically involves a:
- Site Information Sheet. For help with information typically required for the Site Information Sheet, click here.
- Confidentiality and Disclosure Agreement (CDA). Please note that all CDA's must be reviewed and signed by the University and not by PI. Please forward all draft CDA's to Sharon Prisco, MS, JD at:
Contact Tony L Hursey, MPH at 202-687-6408 for any questions concerning CDA's.
Step 2
After receipt of the signed confidentiality agreement, the sponsor should supply you with:
- The study protocol and investigator brochure (IB)
- A draft Clinical Trial Agreement (CTA)
- The proposed study budget (often provided as an attachment to the CTA)
Step 3
You should:
- Review the protocol:
- complete the IRB form (IRB involved)
- complete your informed consent form (ICF) using the sponsor supplied ICF and the Georgetown ICF template for reference
- Fill out a Transmittal sheet and forward (along with a copy of the study protocol) to your department chairman for signature. The Transmittal sheet is required by OSR in order to complete execution of your study contract.
- Forward the draft of the CTA to OSR and supply the study sponsor with contact information for OSR. (OSR involved)
- Forward the draft budget and a copy of the protocol to the CTO to begin work on the budget for your study. (CTO involved)
Step 4
Consider any other additional departments that you might need to work with in starting up your study.
Step 6
Check out the final checklist before you begin.
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