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CHANGES CLARIFICATION FORMPROTOCOL INFORMATION Protocol Number:Protocol Title:Principal Investigator:Please describe any changes to this protocol. The IRB will review these changes to determine if
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The doc clarification form is used to provide additional information or clarification regarding documentation that may be incomplete or unclear in the context of regulatory or compliance requirements.
Individuals or organizations that have submitted documentation that requires clarification, or have been notified by regulatory bodies to provide further information, are required to file the doc clarification form.
To fill out the doc clarification form, provide clear and complete answers to the questions asked, include any supporting documentation or evidence needed, and ensure that all required fields are filled out accurately.
The purpose of the doc clarification form is to rectify issues with submitted documents, ensuring that all necessary information is included for compliance review and to prevent delays in processing.
The information that must be reported includes the specific documents needing clarification, the reasons for the clarification, any additional data or documents requested, and contact information of the person responsible for the submission.
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