IRB Protocol Template ICH-GCP — Free Download

Required sections for an IRB protocol (ICH-GCP E6(R2))

ICH Harmonised Guideline for Good Clinical Practice — E6(R2) 2016 (current version).

Section	What reviewers look for
Title page	Protocol title, version number and date, sponsor name, PI name and contact, CRO if applicable.
Background & rationale	Clinical need for the study, gaps in existing evidence, preliminary data supporting feasibility.
Objectives & hypotheses	Primary and secondary objectives stated as measurable hypotheses. Not just "to investigate" — be specific.
Study design	Design type, phase, blinding, randomisation method, control arm justification.
Subject selection	Inclusion and exclusion criteria written as unambiguous bullet lists. Justify exclusions that limit generalisability.
Study procedures	Visit schedule (table format), what happens at each visit, who performs each procedure.
Outcome measures	Primary and secondary outcomes with measurement method and timeframe for each.
Sample size	Power calculation with effect size, α, β, and assumptions. Justify expected effect size from prior literature.
Statistical analysis	Primary analysis method, handling of missing data, sensitivity analyses, interim analysis plan if applicable.
Risk-benefit assessment	Enumerate risks (physical, psychological, privacy). Justify that benefits outweigh risks. Monitoring plan.
Informed consent	Who obtains consent, when, and how. Language accessibility. Waiver of consent justification if applicable.
Data management	Data storage (location, encryption), access controls, retention period, de-identification method.
Ethical considerations	Address autonomy, beneficence, non-maleficence, and justice. Vulnerable populations if applicable.
Funding & COI	Funding sources and any conflicts of interest for PI and co-investigators.

Region-specific IRB formatting built in

Select your IRB system and CliniDraft generates the protocol in the correct format: Singapore DSRB online submission format, Taiwan bilingual headings (人體研究法), US FDA Common Rule (45 CFR 46), or EU Clinical Trials Regulation 536/2014.

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Common IRB submission questions

What is ICH-GCP E6(R2) and do I need to follow it?

ICH-GCP E6(R2) (2016) is the international guideline for Good Clinical Practice in trials involving human subjects. It is required by regulatory agencies (FDA, EMA, HSA Singapore, TFDA Taiwan) for studies seeking regulatory approval. For observational studies, full GCP compliance may not be legally required, but following its documentation standards is considered best practice and expected by many ethics committees.

What is a waiver of consent, and when is it permitted?

A waiver of consent (or waiver of documentation) may be granted by the IRB for retrospective chart reviews, minimal-risk studies where consent would make the study infeasible, or emergency research. The application must justify that the research cannot practicably be conducted otherwise and that subjects' rights are protected. Requirements vary by jurisdiction — Singapore BAC guidelines and US OHRP have slightly different criteria.

How long does IRB approval take in Singapore and Taiwan?