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INSTITUTIONAL ETHICS REVIEW COMMITTEE CONTINUING REVIEW/ PROGRESS REPORT FORM EC Reference No.: CT Protocol No.: Sponsor initiated Trial Principal Investigator: Institute×Department: Sponsor×CRO

How to fill out continuing review progress report

How to fill out Continuing Review Progress Report:

1. Start by gathering all the necessary information and documents related to the study or research project that is undergoing the continuing review process. This may include previous progress reports, protocols, consent forms, and any changes made since the previous review.
2. Begin by providing the basic information about the study, such as the title, principal investigator, study site, and the dates during which the review is being conducted. This will help identify the specific project being reviewed.
3. Describe the progress that has been made since the last review. Include any significant milestones, data collected, analysis conducted, or any changes made to the study design or procedures. Be concise yet informative in presenting the information.
4. Address any challenges or obstacles encountered during the progress of the study. This may include difficulties in recruitment, unexpected adverse events, or changes in the research team. Provide an explanation of how these challenges were overcome or how they are being addressed.
5. Summarize any amendments made to the study protocol or any changes to the informed consent process. Include the rationale behind these changes, the date they were implemented, and any communication that took place with participants or institutional review boards.
6. Discuss any potential risks or concerns related to participant safety, privacy, or confidentiality. Include any actions taken to mitigate these risks or any measures put in place to ensure compliance with ethical guidelines and regulations.
7. Provide an update on the status of participant enrollment, retention, and completion. Include the total number of participants recruited, any dropouts or withdrawals, and the reasons behind them. This information helps evaluate the feasibility and progress of the study.
8. Detail any collaborations or partnerships that have been established during the course of the research project. This could be with other institutions, researchers, or organizations. Explain the nature of these collaborations and their significance in advancing the study objectives.
9. Finally, conclude the progress report by mentioning any future plans or anticipated milestones. This could include upcoming data analysis, additional recruitment efforts, or any planned amendments. Highlight the expected timeline for completing the study.

Who needs a Continuing Review Progress Report:

1. Researchers and principal investigators involved in studies or research projects that are subject to ongoing review by an institutional review board (IRB) or ethics committee.
2. Institutional review boards and ethics committees responsible for overseeing the ethical conduct of research involving human participants.
3. Regulatory authorities or funding agencies that require periodic progress reports to ensure compliance, monitor the study's progress, and assess its scientific merit.

Remember, the exact requirements for a Continuing Review Progress Report may vary depending on the specific institution, research guidelines, and applicable regulations. It is essential to consult the relevant guidelines and instructions provided by the IRB or ethics committee to ensure accurate and complete reporting.

For pdfFiller’s FAQs

What is continuing review progress report?

The continuing review progress report is a document that provides updates on the progress of ongoing research studies.

Who is required to file continuing review progress report?

Researchers or investigators conducting clinical trials or research studies involving human subjects are required to file the continuing review progress report.

How to fill out continuing review progress report?

The continuing review progress report can be filled out by providing detailed information about the progress of the study, any changes to the protocol, and any adverse events that have occurred.

What is the purpose of continuing review progress report?

The purpose of the continuing review progress report is to ensure that ongoing research studies involving human subjects continue to meet ethical and regulatory standards.

What information must be reported on continuing review progress report?

Information such as study progress, protocol changes, adverse events, and any deviations from the original study protocol must be reported on the continuing review progress report.

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