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Effective date: 01/09/2013 SOP 05/V4Management of Protocol SubmissionsInstitutional Ethics Committee (IEC) Seth G.S. Medical College and K.E.M. Hospital, Pearl, Mumbai 400 012. Page 1 of 42Title:Management
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How to fill out an audit of protocol
How to fill out an audit of protocol
01
Gather all necessary documents related to the protocol being audited.
02
Review the protocol thoroughly to understand its objectives, methods, and outcomes.
03
Identify any potential areas of concern or non-compliance with regulations.
04
Create a checklist of criteria to evaluate during the audit.
05
Schedule meetings with relevant stakeholders to discuss the protocol and gather additional information.
06
Conduct on-site visits or remote assessments as necessary.
07
Document all findings and recommendations in a comprehensive audit report.
08
Present the audit report to the appropriate parties for review and follow-up actions.
Who needs an audit of protocol?
01
Researchers conducting clinical trials
02
Healthcare organizations implementing new treatment protocols
03
Pharmaceutical companies developing new drugs
04
Regulatory agencies overseeing healthcare practices
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What is an audit of protocol?
An audit of protocol is a systematic and independent examination of a research study's protocols and procedures to ensure compliance with regulatory requirements.
Who is required to file an audit of protocol?
Researchers, institutions, or organizations conducting research studies are typically required to file an audit of protocol.
How to fill out an audit of protocol?
The audit of protocol is typically filled out by detailing the study's protocols and procedures, documenting any changes made during the study, and providing supporting documentation.
What is the purpose of an audit of protocol?
The purpose of an audit of protocol is to ensure that research studies are being conducted in accordance with ethical standards, regulatory requirements, and the approved protocols.
What information must be reported on an audit of protocol?
The audit of protocol must report on the study's protocols, procedures, any deviations from the approved protocols, and the measures taken to address them.
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