UK Office of Research Integrity

Menu

Quality Improvement Resources:
Checklists, Study Logs & Sample SOP

Click on the description of your choice in the menu below:

Click here for free Acrobat Reader software, needed for opening PDF links.


 

Key Elements for Notes Describing the Informed Consent Process

 

  • 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):

  • Template for History/Progress Note in Medical Record (UK) [PDF]
  • Researcher's Certification of Consent and Authorization (AHRQ) [PDF]
Back to Top

Sample Study Logs

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.

(alphabetical order)

  • Adverse Event Log [WORD] [PDF]
  • Amendment Tracking Log [WORD] [PDF]
  • Binder Log [WORD] [PDF]
  • Case Report Form Log [WORD] [PDF]
  • Concomitant Medication Log [WORD] [PDF]
  • Consent Document Log [WORD] [PDF]
  • Drug Dispensing Log [WORD] [PDF]
  • Enrollment Log Sample 1 [WORD] [PDF]
  • Enrollment Log Sample 2 [WORD] [PDF]
  • Investigational Device Accountability Log [WORD] [PDF]
  • Investigational Product Accountability Log [WORD] [PDF]
  • Investigator Brochure Log [WORD] [PDF]
  • IRB Correspondence Log [WORD] [PDF]
  • Monitoring/Auditing Log [WORD] [PDF]
  • Notes-to-File Log [WORD] [PDF]
  • Other Correspondence Log [WORD] [PDF]
  • Protocol Log [WORD] [PDF]
  • Regulatory Documents Log [WORD] [PDF]
  • Screening Log [WORD] [PDF]
  • Site Correspondence Log [WORD] [PDF]
  • Staff Signature Log Sample 1 [WORD] [PDF]
  • Staff Signature Log Sample 2 [WORD] [PDF]
  • Subject Files and Source Document Log [WORD] [PDF]
  • Telephone/Communications Log [WORD] [PDF]
  • Training Log [WORD] [PDF]
  • Visitor Log [WORD] [PDF]

Back to Top

Consent/Assent Form Checklist

Use this checklist to identify essential elements of informed consent for University of Kentucky human research. [PDF]

 

Basics for Easy-to-Read Informed Consent Documents

Use this document as a guide for developing an easy-to-read consent document: [PDF]

Use this Glossary of Lay Terms to help prepare an easy-to-understand consent document: [PDF]

 

Investigational Device Accountability SOP Template

If you are conducting a study involving use of an investigational device, use this SOP as a guide for developing your own policies and procedures which can help ensure you are meeting the highest standards for human research protections. [PDF]

 

Back to Top