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

• ALCOA Standards
• Regulatory Binder
• Study Files and Documentation

Sample Documents

• Signature / Delegation of Authority Log Template
• Site Screen and Enrollment Log
• Note to File

Self-Assessments

• Informed Consent Self-Assessment Tool
• Regulatory Binders Self-Assessment Tool
• Study Files and Documentation Self-Assessment Tool 

UAMS Institutional Review Board Templates Informed Consent & Protocol Template 

• Basic Protocol Template October 2019
• Revised Common Rule-Compliant Plain Language Consent Template June 2019
• Concise and Focused (aka Key Information) Summary template
• HIPAA Authorization Template October 2013
• Consent for Non-English Speakers
• Consent Process Note 2016