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Regulatory/​Compliance Resources

Regulatory compliance, including management of eTMF and Investigator Site Files; FDA audits; and regulatory compliance. See more about Regulatory/​Compliance

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The 5 Stages of an FDA Audit, as Told by Research Site Owners Bob Bedetti Regulatory/Compliance
The 5 Stages of an FDA Audit, as Told by Research Site Owners

Hear what it feels like to endure an FDA audit as a Principal Investigator or clinical research site owner, based on interviews with current or former site owners and operators.

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Why do FDA Citations Happen? Ryan Lindeborg Regulatory/Compliance, Regulatory/Compliance
Why do FDA Citations Happen?

A short primer on common FDA findings.

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CRIO Receives Part 11 and Annex 11 Attestation Anna Krauss Regulatory/Compliance
CRIO Receives Part 11 and Annex 11 Attestation

Learn what third party attestation is, and why it's so important that your eSource or eRegulatory vendor have one.

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Are Your Regulatory Binders Ready for a Monitoring Visit? 5 Tips to Ensure a Positive Outcome Dipti Pradhan Regulatory/Compliance
Are Your Regulatory Binders Ready for a Monitoring Visit? 5 Tips to Ensure ...

Best practices for maintaining an audit-proofed regulatory binder.

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Should My Site Hire A Regulatory Specialist? Dipti Pradhan Regulatory/Compliance
Should My Site Hire A Regulatory Specialist?

When you should hire a Regulatory Specialist versus when you should hire a Coordinator.

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Why do FDA Citations Happen? Ryan Lindeborg Regulatory/Compliance, Regulatory/Compliance
Why do FDA Citations Happen?

A short primer on common FDA findings.

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