Please note: These logs may not suit your protocol precisely, however, they may serve as a guide to get you started. Also, be mindful of HIPAA and when it might apply to data collected in pre-screen and enrollment logs.
Quality Assurance/Improvement Resources: Checklists, Study Logs & Sample SOP
Consent/Assent Form Checklist
Use the "Consent/Assent Checklist: Quality Improvement Review" to identify essential elements of informed consent for University of Kentucky human research.
Tools for Developing Informed Consent Documents
Informed Consent/Assent
- Federal Plain Language Guidelines (plainlanguage.gov)
- Glossary of Lay Terms for Use in Preparing Consent Documents
- “Basics for Easy-to-Read Informed Consent Documents” Checklist [O11.0000]
- Lay Terms & Alternative Words
- Everyday Words for Public Health Communication (Centers for Disease Control and Prevention (CDC))
- Informed Consent Language (ICL) Database (National Comprehensive Cancer Network (NCCN))
- Simplified Assent Form Language Toolkit (Quorum)
- Standard Drug Risk Language Library (Dana Farber/Harvard Cancer Center Office of Human Research Studies)
- Standard Risk Language Database (Dana Farber/Harvard Cancer Center Office of Human Research Studies)
- Suggested Consent Language (Northwestern Office for Research Institutional Review Board (IRB))
- Tables of Possible Side Effects for Commonly-Used Oncology Regimens (National Institutes of Health (NIH) National Cancer Institute (NCI))
- Talking Glossary of Genetic Terms (National Institutes of Health (NIH))
- Readability Toolkit (Kaiser Permanente Washington Research Institute Program for Readability & Science in Medicine (PRISM))
Investigational Device Accountability SOP Sample
If you are conducting a study involving use of an investigational device, use the Sample Policy/Procedure Template: Investigational Device Accountability and Investigational Device Accountability log as a guide for developing your own policies and procedures which can help ensure you are meeting the highest standards for human research protections.
Detailing the Informed Consent Process in the Subject's Source Document
- Statement that “eligibility criteria met” (or completed eligibility checklist attached);
- Date;
- Details of who involved/present;
- Description of process;
- Discussion items;
- Questions & clarifications;
- Any assessment used to document understanding;
- Statement that subject voluntarily consented to participate prior to participating;
- Copy of signed consent given to subject;
- Any other pertinent information (witness, LAR, supplemental materials);
- PI contact information;
- IRB number;
- Protocol title;
- Version of the consent document signed.
Samples (Please note: These may not suit your protocol precisely, however, they may serve as a guide to get you started):