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Institutional Review Board CONTINUING REVIEW /CLOSURE REPORT CONTINUING REVIEW REPORT CLOSURE REPORT Submission Date: Instructions: Please read and complete the entire form. Missing information will
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How to fill out continuing review or study:

01
Start by carefully reading through the form or questionnaire provided for the continuing review or study process.
02
Provide accurate and updated information about the study, including the study title, principal investigator, study site(s), and any changes made since the previous review.
03
Clearly articulate the objectives and aims of the study, ensuring they align with the original research proposal.
04
Include a summary of the study procedures and methods, highlighting any modifications or new additions since the last review.
05
Describe any adverse events or unexpected outcomes that have occurred during the study period and provide an analysis of how they were addressed or mitigated.
06
Outline the recruitment and informed consent process for participants, ensuring ethical considerations and participant safety.
07
describe any changes made to the study team since the previous review, including new members, changes in roles or responsibilities, and their qualifications.
08
Detail any proposed amendments to the study protocol, if applicable, explaining the rationale behind these changes and assessing their potential impact on participant safety or study outcomes.
09
Provide updated information on any funding sources for the study, as well as any conflict of interest declarations for the study team members.
10
Finally, review the completed form or questionnaire for accuracy and clarity before submitting it for review.

Who needs continuing review or study?

01
Researchers or principal investigators conducting human subjects research that has been approved by an institutional review board (IRB) typically need to undergo continuing review or study.
02
This process ensures that the ongoing study adheres to ethical guidelines, participant safety, and the updated regulations or standards in the field.
03
The purpose of continuing review or study is to evaluate the progress of the study, assess any modifications or amendments made, and ensure the ongoing protection of participants involved in the research.
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Continuing review or study is the process of evaluating the ongoing progress and ethical considerations of a research study.
Researchers conducting human subjects research are typically required to file continuing review or study.
Continuing review or study forms are typically submitted through an institution's research compliance office or IRB portal.
The purpose of continuing review or study is to ensure that research studies involving human subjects adhere to ethical standards and regulatory requirements.
Information such as any adverse events, protocol deviations, changes to study procedures, and updates on participant recruitment must be reported on continuing review or study.
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Relevant keywords

2015 IRB COI summarizes III Unanticipated DEVIATIONS inclusion enrolling cumulative exclusion Institutional Populations Inception ENROLLMENT Adolescents Participant thru ADVERSE participants Deviation RECRUITMENT actively completing Modification statistic

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