Patient and Caregiver
Investigator
Regulator
IRB
Tech, Device,
PayerTrial Design Stage
Published Date: April 29, 2025
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Helpful Terms and Definitions
Draft Protocol
Questions To Ask
- What considerations should I take into account when defining the inclusion and exclusion criteria for participants?
- Are there any specific regulatory standards or guidelines that my study must adhere to?
- What are the IRB's expectations for the informed consent process, and how can I ensure it is comprehensive and clear for participants?
Why involve IRBs now?
This is the stage where IRB requirements meaningfully shape the document.
Helpful actions at this stage:
- Use IRB‑provided templates and checklists to ensure all required elements are included.
- Draft detailed sections covering study design, methodology, participant protections, confidentiality, and safety oversight.
- Develop comprehensive procedure lists, including recruitment, screening, consent, study visits, assessments, and follow‑up.
- Work with operational experts (e.g., data management, safety teams) to ensure alignment with IRB expectations.
- Seek internal peer review before submission—especially if you are new to IRB processes.
While the IRB is not reviewing the study yet, crafting the protocol with IRB standards in mind reduces delays later.