For an institutional review board, all of the items a reviewer should find when reviewing a protocol

Protocol Information

Title of the study

Principal investigator and contact information

Study site(s)

Version number and date of the protocol

Here are some additional steps that could be included in the Protocol Information section of a checklist for an institutional review board (IRB) review

Brief description of the study

Study identification number (if applicable)

Sponsor information (if applicable)

Collaborating institutions or organizations

Key personnel involved in the study (e.g., co-investigators, research coordinators)

Expected start and end dates of the study

Justification for the study (e.g., importance and relevance of the research)

Funding agency or source of support (if different from the funding and conflicts of interest section)

Approval history (previous IRB approvals or amendments, if applicable)

Summary of changes from previous versions of the protocol

Contact information for the study sponsor (if applicable)

Anticipated enrollment timeline or milestones

These additional steps help ensure thorough documentation and clarity about the study's framework, personnel, and timeline, which are essential for effective IRB review

Study Objectives and Hypotheses

Clearly defined objectives

Testable hypotheses

Study Design

Type of study (e.g., randomized, observational)

Description of study population

Inclusion and exclusion criteria

Sample size justification

Randomization and blinding methods (if applicable)

Intervention Details

Description of the intervention(s)

Duration and frequency of the intervention

Control group details (if applicable)

Risks and Benefits

Assessment of potential risks to participants

Description of anticipated benefits

Risk-benefit analysis

Recruitment

Recruitment strategies

Participant consent process

Methods for ensuring participant understanding

Informed Consent

Informed consent document attached

Clarity of language and terminology

Explanation of participant rights and withdrawal process

Data Collection and Management

Data collection methods

Data management and storage procedures

Confidentiality measures

Plans for data sharing and publication

Statistical Analysis

Statistical methods to be used

Plans for handling missing data

Analysis plan transparency

Ethical Considerations

Compliance with ethical guidelines

Institutional policies adhered to

Plans for monitoring safety and adverse events

Funding and Conflicts of Interest

Funding sources

Disclosure of potential conflicts of interest

Additional Documents

Any supplementary documents (e.g., surveys, recruitment materials)

Approval from other relevant committees (if applicable)

Review and Approval

Signature and date of the principal investigator

Required signatures from co-investigators (if applicable)

Submission date for IRB review