What documentation must be provided to the IRB for approval of a clinical trial?

The appropriate documentation that must be provided to the Institutional Review Board (IRB) for the approval of a clinical trial includes the study protocol, informed consent documents, and any recruitment materials.

The study protocol outlines the objectives, design, methodology, statistical considerations, and organization of the trial, ensuring that the study is planned systematically and ethically. Informed consent documents are vital because they detail the information that participants need to understand the study, their rights, and any potential risks involved before agreeing to participate. Recruitment materials, which communicate how participants will be approached and informed about the study, are also critical to ensure that the recruitment process adheres to ethical standards and regulatory requirements.

This comprehensive documentation allows the IRB to assess the ethical and scientific merit of the proposed study to ensure participant safety and compliance with regulations. In contrast, other options either lack the necessary elements for ethical review or involve documentation that is not required at the initial approval stage of the study.