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Continuing Review Checklist for Reviewers PI Name: Title of Protocol: Reviewer: Section 1 Regulatory Criteria for Approval Regulatory Criteria (Section 111 Criteria): The following information is

How to fill out continuing review master checklist

How to Fill Out Continuing Review Master Checklist?

1. Begin by carefully reviewing the instructions provided with the continuing review master checklist. Familiarize yourself with the purpose and requirements of the checklist.
2. Start by entering essential information in the designated fields. This may include the name of the study, research site, protocol number, and investigator's name.
3. Identify the study team members involved in the review. Include their names, roles, and contact information, ensuring all relevant personnel are included.
4. Evaluate the progress of the study by assessing whether the research is being conducted according to the approved protocol, applicable regulations, and any specific study requirements.
5. Review and document any potential protocol deviations or non-compliance issues that have occurred since the last review. Ensure thorough documentation and provide appropriate explanations for any discrepancies.
6. Assess the safety of the study participants. Review any adverse events, serious adverse events, or unexpected problems that have been reported since the last review. Record these incidents, along with any actions taken to address them.
7. Evaluate the data management practices and ensure that the study data is being collected, recorded, and stored accurately and securely. Address any concerns or gaps in data management, and update the checklist accordingly.
8. Examine the informed consent process to ensure that participants are properly informed about the study and have given their voluntary consent. Verify that any changes to the informed consent documents have been appropriately documented and approved.
9. Determine whether any modifications to the study protocol, procedures, or documents are necessary. If so, outline the proposed modifications, including the rationale and potential impact on the study and participants.
10. Identify any outstanding regulatory or ethical issues that need to be addressed and formulate a plan to resolve them. Document any correspondence or actions taken to address these issues.
11. Finally, provide a summary of the review, highlighting the main findings, actions taken, and any recommendations for future improvements. Sign and date the checklist to confirm completion.

Who needs a Continuing Review Master Checklist?

1. Principal Investigators (PIs) conducting research studies that require ongoing review and oversight.
2. Research coordinators or study staff responsible for managing the administrative aspects of the research study.
3. Institutional Review Boards (IRBs) or Ethical Review Committees who review and oversee the research to ensure compliance with ethical standards and regulations.
4. Quality Assurance/Quality Control personnel who monitor the conduct of research studies to maintain compliance with applicable guidelines and regulations.
5. Sponsors or funding agencies who require periodic reporting and monitoring of the research study's progress and safety.
6. Study participants, as ongoing review and oversight help ensure their safety and protection throughout the course of the research study.

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What is continuing review master checklist?

The continuing review master checklist is a document used to ensure that all necessary steps are taken during the review process of research protocols.

Who is required to file continuing review master checklist?

The Principal Investigator or research team is typically required to file the continuing review master checklist.

How to fill out continuing review master checklist?

The continuing review master checklist can be filled out by providing information on the ongoing status of the research, any protocol amendments, adverse events, and other required details.

What is the purpose of continuing review master checklist?

The purpose of the continuing review master checklist is to ensure that research protocols are being followed properly and that any necessary updates or changes are addressed in a timely manner.

What information must be reported on continuing review master checklist?

Information such as ongoing status of the research, protocol amendments, adverse events, and any other relevant details must be reported on the continuing review master checklist.