How to prepare an IRB submission

IRB submission is a critical step in the setup of a clinical study. This guide covers required documents, timelines, and common pitfalls.

1. 1

   Finalize the protocol

   Include hypothesis, population, variables, sample size, statistical plan, safety monitoring, and data management.

2. 2

   Prepare informed consent form

   In accessible language, with explicit data processing consent per GDPR/HIPAA. Version and date required.

3. 3

   PI and co-investigator credentials

   Signed and dated CVs. Credentials, research experience, recent GCP training (<2 years).

4. 4

   Describe the data platform (EDC)

   Technical documentation: encryption, audit trail, access control, GDPR/HIPAA compliance.

5. 5

   Insurance policy

   Trial-specific liability insurance with required minimum coverage.

6. 6

   Application form

   Official IRB form signed by PI and sponsor.

7. 7

   Submission and follow-up

   Online submission. Typical response time: 30-60 days. Be prepared for clarification requests.