The following materials are required to start study development. Our study staff are instructed to wait for the receipt of all applicable documents before moving forward with initiating IRB application, budget, and contract process.
Sponsor Document Collection
Regulatory Manager:
- Final protocol
- Informed consent (draft)
- Investigator Brochure
- DSMB Charter (at minimum, draft)
- Lab Manual
- Pathology Manual
- Pharmacy Manual
- Imaging Manual
- CRF
- Recombinant DNA Advisory Committee Letter (if applicable)
- FDA Letter (IND/IDE designation
- Participant Materials
- Advertising Materials
- Clinicaltrials.gov #
- Company Information Sheet
- 1572
Sponsored Project Administration:
- Budget template (draft)
- Clinical Trial Agreement (draft)
- Financial Disclosure
Study Development
Once all study documents are received, the study will be assigned to a study development team. There are several development activities to complete, including:Clinical Research Advisory Board (CRAB) review
- Accrual feasibility assessment
- Gathering budget element, including personnel efforts, pharmacy, radiology, laboratory and any other required service costs
- Drafting informed consent using Tulane Template and obtaining sponsor approval
- IRB Financial Disclosures for all study staff
- Preparation of the IRB application
Study Activation
- Budget creation and negotiation
- Contract review and negotiation
- Hospital approval and account set-up
- Grant account set-up
- Site Initiation and trainings
