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Self-Assessment Tools and Templates
Use these self-assessment tools to guide your own review of study records and processes. Print off as many copies as you need, and feel free to change these documents to better fit your study. You can then use the self-assessment findings to make any necessary changes in your research processes or documentation.
Informed Consent Process Self-Assessment Tool
Informed Consent Process Note Template
Regulatory Binders Self-Assessment Tool
Signature/ Delegation of Authority Log Template
Subject Study Files and Source Documentation
Subject Records and Source Documentation Self-Assessment Tool
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.