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Sponsor Regulatory File Checklist
* denotes items also applicable to nonclinical research
AgreementsTransfer of obligations (if using a Clinical Research Organization (CRO))*Protocol DocumentsFinal
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What is sponsor regulatory file checklist?
Sponsor regulatory file checklist is a document outlining the required regulatory documentation needed for a clinical trial.
Who is required to file sponsor regulatory file checklist?
The sponsor of the clinical trial is required to file the sponsor regulatory file checklist.
How to fill out sponsor regulatory file checklist?
The sponsor must review the checklist and gather all necessary regulatory documents to complete the form.
What is the purpose of sponsor regulatory file checklist?
The purpose of the sponsor regulatory file checklist is to ensure all regulatory documentation for a clinical trial is in compliance with regulations.
What information must be reported on sponsor regulatory file checklist?
The sponsor regulatory file checklist must include information on protocol approvals, informed consent forms, and adverse event reporting procedures.
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