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TANEY COUNTY HEALTH DEPARTMENT INFORMATION FOR CONTINUING REVIEW OF A PREVIOUSLY APPROVED PROJECT IRB FORM 2 All ongoing research activity that was not determined to be exempt from IRB review must

How to fill out information for continuing review

1. Start by gathering all the necessary documents for the continuing review process. This may include the previous review report, updated protocols, consent forms, and any other relevant information.
2. Review the instructions provided by the institution or the regulatory body overseeing the review process. These instructions will guide you on what specific information needs to be included and the format in which it should be provided.
3. Begin filling out the information by providing the general details of the study, such as the title, principal investigator, study site, and date of the original review.
4. Describe any modifications or amendments that have been made to the study since the last review. This could include changes in the study design, population, interventions, or procedures.
5. Assess and report on any adverse events or unexpected outcomes that have occurred since the last review. It is important to provide a detailed description of these events, including any actions taken to address them.
6. Evaluate the ongoing recruitment status and participant enrollment numbers. Include information on any challenges or difficulties encountered during the recruitment process.
7. Discuss any interim data or preliminary results that have been obtained during the course of the study. This may include summary statistics or trends that can help inform the continuing review.
8. Address any outstanding issues or concerns raised during the previous review. Provide updates on the progress made in resolving these issues.
9. Enumerate any changes in the study personnel, including new staff members or changes to existing roles and responsibilities.
10. In addition to the above points, it is essential to consult the specific guidelines or requirements of the reviewing entity to ensure all necessary information is included.

Who needs information for continuing review?

1. The principal investigator, as the lead researcher, needs this information to ensure compliance with regulations and to keep the study on track.
2. The research team members involved in the study should also be aware of the information provided for continuing review to ensure proper implementation of study procedures.
3. The institutional review board (IRB) or ethics committee overseeing the study will require this information to assess the ongoing ethical and scientific validity of the study.
4. Regulatory authorities or governing bodies responsible for monitoring research may also request this information to ensure compliance with regulations and to protect the rights and welfare of study participants.
5. Funding agencies or sponsors supporting the research will want to stay updated on the progress and relevance of the study.

Remember to always follow the specific guidelines and instructions provided by your institution or regulatory body when filling out information for continuing review.

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What is information for continuing review?

Information for continuing review refers to documentation that needs to be submitted to the appropriate regulatory bodies in order to continue a research study.

Who is required to file information for continuing review?

Researchers conducting a study that has been approved by an Institutional Review Board (IRB) are required to file information for continuing review.

How to fill out information for continuing review?

Information for continuing review is typically filled out by the principal investigator of the research study, following guidelines provided by the IRB.

What is the purpose of information for continuing review?

The purpose of information for continuing review is to ensure that the research study is still being conducted ethically and in compliance with regulations.

What information must be reported on information for continuing review?

Information for continuing review typically includes updates on the study progress, any adverse events, and changes in study procedures.