Tools and Templates

Use these tools to guide your own review of study records and processes. Feel free to change these documents to better fit your study.

Info Sheets

Informed Consent

Regulatory Binders

Study Files and Documentation

Sample Documents

Informed Consent Process Note Template

Signature/ Delegation of Authority Log Template

Informed Consent Form Checklist

Using the Informed Consent Form Checklist

Self-Assessments

Informed Consent Self-Assessment Tool (pdf)

Regulatory Binders Self-Assessment Tool (pdf)

Study Files and Documentation Self-Assessment Tool (pdf)

ORC can also help you develop a plan for any problems found during these self-assessments. Please contact us by phone or email if you’d like our help following up on any self-assessment findings.

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