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Protocol Review and Monitoring Committee Policies and Procedures Effective December 2014 Revised Dec 2014 2 Tables of Contents 1. The Protocol Review and Monitoring Committee 3 2. Goals and Responsibilities

How to fill out protocol review and monitoring

How to fill out protocol review and monitoring:

1. Start by carefully reading the protocol document. This will provide you with a clear understanding of the study objectives, procedures, and specific requirements for review and monitoring.
2. Familiarize yourself with the relevant guidelines and regulations governing protocol review and monitoring. These may vary depending on the nature of the study and the country or institution where it is being conducted.
3. Compile all the necessary documentation, including the protocol, informed consent forms, case report forms, and any other relevant study materials.
4. Review the protocol thoroughly to ensure that it aligns with ethical standards, scientific validity, and regulatory guidelines. Check for any inconsistencies, omissions, or potential risks that need to be addressed.
5. Collaborate with the principal investigator and other members of the research team to address any identified issues or modifications required in the protocol. This may involve revising the study objectives, adjusting the sample size, or modifying the study procedures.
6. Ensure that the protocol is complete and understandable for all stakeholders involved, including researchers, ethics committees, regulatory authorities, and study participants. Use clear and concise language to describe the study design, interventions, outcomes, and safety measures.
7. Submit the protocol for review and approval by the relevant ethics committee, institutional review board (IRB), or regulatory authority. Provide all the necessary supporting documents, including the completed protocol, informed consent forms, and investigator's brochure.
8. Monitor the progress of the study according to the approved protocol. This includes regularly reviewing data collection, participant enrollment, adverse events reporting, and compliance with study procedures.
9. Comply with any monitoring requirements specified in the protocol, such as on-site visits, source data verification, and quality control checks. Document all monitoring activities conducted and address any deviations or non-compliance promptly.

Who needs protocol review and monitoring:

1. Researchers and scientists conducting clinical trials or other research studies involving human participants. Protocol review and monitoring are essential to ensure the safety and welfare of study participants, ethical conduct of the research, and reliability of the collected data.
2. Ethics committees and IRBs responsible for reviewing and approving research protocols. They need protocol review and monitoring to assess the scientific validity, ethical considerations, and regulatory compliance of the proposed study.
3. Regulatory authorities and government agencies overseeing research activities. They require protocol review and monitoring to ensure that studies adhere to relevant guidelines, regulations, and legal requirements.
4. Study sponsors and funders who invest in research projects. They rely on protocol review and monitoring to ensure the quality, integrity, and successful completion of the study, as well as to protect their investments.

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