Patient and Caregiver
Investigator
Regulator
IRB
Tech, Device,
PayerTrial Design Stage
Published Date: April 29, 2025
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Helpful Terms and Definitions
*This list is not exhaustive, nor does CTTI officially endorse the resources created by other organizations.
Draft Protocol
Questions To Ask
- What should be considered when defining inclusion and exclusion criteria to ensure appropriate participant protection?
- What regulatory requirements and ethical standards must the study meet (e.g., FDA, ICH, Common Rule)?
- What are IRB expectations for the informed consent process, and how can clarity and comprehension be ensured for participants?
For the purposes of this roadmap, “IRB” refers to Institutional Review Boards in the United States and Ethics Committees (ECs), including Independent Ethics Committees (IECs), in global research settings.
Why involve IRBs now?
At the draft protocol stage, IRB expectations directly shape the structure and content of the protocol.
Although formal review has not yet occurred, aligning the protocol with IRB requirements at this stage helps ensure that all necessary elements—particularly those related to participant protection, consent, and safety—are complete and appropriately described. This reduces the likelihood of major revisions during IRB submission.
Helpful actions at this stage:
- Use IRB templates and checklists to ensure required elements are included
- Draft detailed sections on study design, methodology, participant protections, confidentiality, and safety oversight
- Develop comprehensive procedures (e.g., recruitment, screening, consent, study visits, assessments, follow-up)
- Align with functional teams (e.g., safety, data management) to ensure consistency and completeness
- Conduct internal review prior to IRB submission