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This form is used for the ongoing review or closure of research projects approved by the Institutional Review Board (IRB) at Bon Secours Richmond Health System. It collects information on the status
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How to fill out Bon Secours Richmond Health System (BSRHS) IRB CONTINUING REVIEW OR CLOSURE FORM
01
Begin by downloading the Bon Secours Richmond Health System IRB Continuing Review or Closure Form from the official website.
02
Fill in the project title at the top of the form.
03
Provide the principal investigator's name and contact information.
04
Include the IRB approval number associated with the study.
05
Specify the current status of the study (active, completed, etc.).
06
Update the recruitment status and participant enrollment details.
07
Provide any amendments or changes made to the original protocol since the last review.
08
Indicate any adverse events that occurred during the course of the study.
09
Sign and date the form at the bottom.
10
Submit the completed form to the BSRHS IRB office along with any required documentation.
Who needs Bon Secours Richmond Health System (BSRHS) IRB CONTINUING REVIEW OR CLOSURE FORM?
01
Researchers conducting studies approved by the Bon Secours Richmond Health System IRB.
02
Principal investigators who are nearing the end of their approved study period.
03
Anyone managing a research project requiring an ongoing IRB review or closure process.
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What is IRB accreditation?
Introduction to IRB Accreditation For clinical researchers, research institutions, and ethics committees, upholding the highest standards of ethical research is essential. The Institutional Review Board (IRB) plays a key role in ensuring that studies involving human subjects are conducted ethically and safely.
What is the institutional review board accreditation?
While all registered IRBs uphold basic review standards, not all IRBs are accredited. Accreditation, such as through the Association for the Accreditation of Human Research Protection Programs (AAHRPP), signifies that an IRB meets higher standards of quality, efficiency, and ethical oversight.
What is the purpose of the Institutional Review Board?
The IRB must monitor and review an investigation throughout the clinical study. If an IRB determines that an investigation involves a significant risk device, it must notify the investigator and, if appropriate, the sponsor. The sponsor may not begin the investigation until approved by FDA.
What is the continuing IRB review required for?
Continuing review provides the IRB with an opportunity to determine whether there is any new information that should be considered to represent such a significant new finding and therefore be communicated to subjects who have already enrolled in the research (e.g., important new toxicity information or new adverse
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What is Bon Secours Richmond Health System (BSRHS) IRB CONTINUING REVIEW OR CLOSURE FORM?
The Bon Secours Richmond Health System (BSRHS) IRB Continuing Review or Closure Form is a document used by researchers to request either a continuation or closure of their research studies under the oversight of the Institutional Review Board (IRB).
Who is required to file Bon Secours Richmond Health System (BSRHS) IRB CONTINUING REVIEW OR CLOSURE FORM?
All researchers affiliated with Bon Secours Richmond Health System who have ongoing studies reviewed by the IRB must file the Continuing Review or Closure Form when the study is nearing its expiration or at the time of study closure.
How to fill out Bon Secours Richmond Health System (BSRHS) IRB CONTINUING REVIEW OR CLOSURE FORM?
To fill out the Bon Secours Richmond Health System IRB Continuing Review or Closure Form, researchers should provide detailed information regarding the study's progress, any adverse events, and the justification for continuation or closure, along with any necessary documentation as required by the IRB.
What is the purpose of Bon Secours Richmond Health System (BSRHS) IRB CONTINUING REVIEW OR CLOSURE FORM?
The purpose of the form is to ensure compliance with ethical standards in research involving human subjects by allowing the IRB to evaluate the ongoing risks and benefits associated with the research study, as well as to facilitate the proper closure of studies that have been completed.
What information must be reported on Bon Secours Richmond Health System (BSRHS) IRB CONTINUING REVIEW OR CLOSURE FORM?
The information required on the form includes the study title, investigators involved, study progress, participant enrollment figures, any adverse events, changes to the study protocol, and the overall assessment of the study's risks versus benefits.
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