Essential Documents – Regulatory Study Startup

Essential Documents are documents which individually and collectively permit evaluation of the conduct of a clinical trial and quality of the data produced

EDs help assist the PIs/sites and the sponsor. They demonstrate adherence to GCP standards and all other applicable regulatory requirements.

EDs are regularly audited by independent audit function (CRAs) of Sponsors and inspected by regulatory authority.

Essential Documents required during Study Startup:

• Clinical Trial Agreement

• Informed Consent Form   

• Confidentiality Disclosure Agreement

• 1572 Form

• Investigator Brochure and Receipt Forms

• Protocol Signature page

• Financial Disclosure Forms

• Insurance statements

• IRB Approval for Site to conduct studies

• CVs of site personnel

• Delegation of Responsibilities log

• IRB Approval

• Training Records

• Laboratory ranges, procedures, certificate accreditations

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