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Page 1 of 3 IRB Request to Re? Open a Closed Study On occasion, researchers seek to temporarily re?open a study after study closure has occurred. This is typically related to a request from the sponsor
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How to fill out irb request to re-open
How to fill out an IRB request to re-open:
01
Determine the reason for re-opening: Before filling out the IRB request, it is important to assess the specific reason for wanting to re-open the study. This could be due to new information, protocol modifications, or participant safety concerns.
02
Gather necessary documentation: When filling out the IRB request, it is crucial to provide all relevant documentation to support the re-opening. This may include updated study protocols, informed consent forms, participant recruitment materials, and any other pertinent information.
03
Review and complete the IRB request form: The IRB request form should be carefully reviewed and completed with accurate and detailed information. This may involve providing details about the study, the reason for re-opening, the proposed modifications, and any potential risks or benefits.
04
Consult with study team members: It is recommended to consult with other members of the study team, such as principal investigators and research coordinators, to ensure that all aspects of the IRB request are accurately addressed. Collaboration can help identify any missing information or potential issues.
05
Submit the IRB request: Once the IRB request form is completed and reviewed, it should be submitted according to the specific guidelines provided by the IRB. This typically involves sending the request electronically or through a designated submission portal.
06
Follow up with the IRB: After submitting the IRB request to re-open, it is important to follow up with the IRB office to ensure that the request is received and being processed. Any additional information requested by the IRB should be promptly provided to facilitate the review process.
Who needs an IRB request to re-open:
Researchers conducting studies involving human subjects and that have already received initial approval from the Institutional Review Board (IRB) may need to submit an IRB request to re-open. This applies when there is a need to modify or update the study protocol, informed consent process, or any other aspect of the ongoing research. The decision to re-open a study is made to ensure participant safety, comply with regulatory requirements, and maintain the integrity of the research. Therefore, researchers who wish to make changes to an approved study must submit an IRB request to re-open for review and approval by the IRB.
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What is irb request to re-open?
The IRB request to re-open is a formal application submitted to the Institutional Review Board to request the re-opening of a previously closed research study.
Who is required to file irb request to re-open?
The principal investigator or research team responsible for the study is required to file the IRB request to re-open.
How to fill out irb request to re-open?
The IRB request to re-open form typically includes information about the study, reasons for re-opening, updated protocol, and any additional documentation required by the IRB.
What is the purpose of irb request to re-open?
The purpose of the IRB request to re-open is to ensure that any changes or re-opening of a study are reviewed and approved by the IRB to protect the rights and welfare of research participants.
What information must be reported on irb request to re-open?
The IRB request to re-open must include details about the changes to the study protocol, any new risks or benefits, updated consent forms, and any other relevant information.
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