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Print Form INSTITUTIONAL REVIEW BOARD (IRB) CONTINUING REVIEW APPLICATION Clearly type all portions of this form. 1. STUDY TITLE IRB PROTOCOL NUMBER EXPIRATION DATE OF STUDY APPROVAL* *If IRB approval

How to fill out continuing review bapplicationb

How to fill out a continuing review application:

1. Review the instructions: Before starting the application, carefully read the provided instructions. Understanding the requirements and guidelines will help you accurately complete the form.
2. Gather necessary information: Collect all the relevant information required for the application. This may include study details, participant information, any changes made to the study since the last review, and any adverse events or unanticipated problems that have occurred.
3. Provide study details: Begin by providing basic study details such as the title, purpose, and objectives of the study. Describe any changes made since the previous review and include any supporting documentation or references, if necessary.
4. Participant information: Include information about the participants in the study, such as the number of enrolled participants, their demographic details, and any changes made to the participant pool since the last review.
5. Risk assessment: Assess and document the potential risks involved in the study. Evaluate the steps taken to mitigate these risks and ensure participant safety. If there have been any changes to the risk assessment since the last review, include them in this section.
6. Adverse events and unanticipated problems: Document any adverse events or unanticipated problems that have occurred during the course of the study. Explain the actions taken to address these issues and prevent their recurrence.
7. Consent process: Provide details about the informed consent process, including how potential participants are informed about the study, the consent form used, and any changes made to the consent process since the previous review.
8. Data management and analysis: Outline how the study data is collected, managed, and analyzed. Include details about the security measures in place to ensure participant confidentiality and data integrity.
9. Study progress: Describe the progress of the study, including the current enrollment status, any challenges or delays encountered, and the anticipated completion date. Provide updates on any significant findings or outcomes of the study as well.
10. Signature and submission: Sign and date the application to indicate that the provided information is accurate and complete. Submit the application as per the specified submission process.

Who needs a continuing review application?

Researchers conducting studies that involve human participants typically need to undergo a continuing review process. This process ensures that ongoing studies adhere to ethical and safety standards. The purpose of continuing review is to evaluate the progress of the study, assess any risks to participants, and verify that the research continues to meet the necessary requirements and regulations.

It is primarily the responsibility of the researchers and the institutional review board (IRB) to determine whether a study requires a continuing review application. The specific criteria and timelines for such reviews may vary based on the nature of the study, the duration of participant involvement, and the guidelines set by the governing regulatory bodies.

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What is continuing review application?

Continuing review application is the process by which researchers must provide updates on their ongoing research projects to the Institutional Review Board (IRB) in order to ensure the protection of human subjects.

Who is required to file continuing review application?

Researchers and Principal Investigators who are conducting research involving human subjects are required to file continuing review applications.

How to fill out continuing review application?

To fill out a continuing review application, researchers must provide updates on any changes to the study protocol, informed consent document, recruitment materials, or any other relevant information.

What is the purpose of continuing review application?

The purpose of continuing review application is to ensure that research projects involving human subjects continue to meet ethical and regulatory requirements, and that the rights and welfare of participants are protected.

What information must be reported on continuing review application?

Researchers must report any adverse events, protocol deviations, enrollment numbers, and any other changes to the study since the last review.