Once a confidential disclosure agreement (CDA) is signed and reviewed by the sponsor, you should receive a protocol, contract template, budget (if already prepared, otherwise assistance is available), and IDE or IND number (if applicable) from the sponsor.
Complete the Clinical Research Protocol Feasibility Checklist (click here)
If the research study will use the Clinical Research Center (CRC), submit the initial application with the required documents on the RCenter portal. Pre-funding support is available in the areas of budgeting, statistical analysis, specific core input, recruitment strategies also regulatory assistance is available at: (404) 752 5022.
Documents to be submitted:
- - The Application Form-All items must be filled out completely for both initial and amendment submissions
- - Protocol-final version, draft protocols cannot be accepted
- - Biosketch of each Investigator
- - Inform Consent
- - Clinical Trial Agreement (CTA) or contract/Award (if Federal funding)
- - Budget Template
- - Investigator Effort calculation
- - Most recent FDA communications, e.g., IND letter that includes IND number, IDE letter that includes IDE number and category assignment
Submit your proposal to the IRB.
The regulatory approval process then begins and the applicant will be notified of the decision.
Review Flow Chart For Industry Funded Clinical Trial Steps