To assist researchers with best practices for their human subjects-related research and facilitate their regulatory compliance efforts, the Office of Research and Scholarship developed a Researcher Toolkit.

The toolkit contains sections on:

  • Guidance and Training: links to SON, UMB, and federal human subjects-related research regulations, guidances, policies, presentations, and instructions
  • Regulatory Binders and Subject Binders: checklists and optional template documents reference matched to applicable regulations and guidance documents
  • Quality Assurance: checklists to assist researchers when self-monitoring their studies
  • Miscellaneous Information

The Researchers Toolkit is intended to assist SON investigators in the organization and conduct of compliant research studies. Please e-mail for specific questions or to provide feedback.

Guidance and Training



UMB Human Research Protections Office (HRPO)

UMB Conflict of Interest Office

UMB Research Integrity Office

UMB Office of the Controller








Regulatory Binder Toolkit

Regulatory Binder Toolkit

The optional templates, samples, examples, and guidance materials found within the toolkits are intended to assist SON investigators in the organization and conduct of compliant research studies. These materials are not meant for blanket application and must be tailored specific to your study prior to use.
Below are template table of contents (TOC) documents and instructions to use as a general guide for expectations according to study risk profile. It is advised to start with a TOC to develop the regulatory binder, which must also be edited to align with the specific study.


Regulatory Binder SectionDocumentsSupporting Regulation/Guidance
Protocol Template Protocol Version Tracking Log ICH E6 8.2.2 & 8.3.2

CICERO Application (You may use your IRB application as your protocol at UMB if you do not have a stand alone protocol.)
Template Social/Behavioral Research Protocol (NIH)
Template Observational Protocol (UNC)
Template Clinical Trial Protocol (NIH)
Template Chart-Review Protocol
IRB Information UMB IRB Roster (Scroll to bottom of link)

45CFR §46.107-108
45CFR §46.115
ICH E6 8.2.8

UMB IRB FWA  (Scroll to bottom of link)
IRB Reliance
IRB Initial Review   IRB Initial Approval Letter 45CFR §46.109-110
ICH E6 8.2.7, 8.2.9, 8.3.4
UMB IV-2.10(A)  
IRB Initial Application (If you did not use CICERO as your protocol.)
IRB Modifications Modification Tracking Log 45CFR §46.109
45CFR §46.111-112
ICH E6 8.3.4
UMB IV-2.10(A)
Modification IRB Approval (The IRB approval document.)
Modification Application (The modification application page "front end" - where the changes are described.)
Modified IRB Application (The CICERO application "back end" - full application now updated due to the modification.)
IRB Annual Review (non-exempt)  IRB Annual Review Approval letter 45CFR §46.108-109
45CFR §46.115
ICH E6 8.4.7, 8.3.19
UMB IV-2.10(A)
IRB Annual Review Application
IRB Reportable New Information RNI Tracking Log 21CFR §312
45CFR §46.108
ICH E6 8.3.11, 8.3.16-17
UMB RNI Criteria
RNI Submissions and Acknowledgements (The copy of the RNI submission and the HRPO/IRB determination letter.)
IRB Communications  Emails, hard-copy communications, etc. Appropriate to create NTF (example) if all communications are electronic through a portal 45CFR §46.108
45CFR §46.115
ICH E6 8.3.11
Consent Template Informed Consent Tracking Log 45CFR §46.109
45CFR §46.116-117
ICH E6 8.2.3, 8.3.2-3, 8.3.13
UMB Template Consent/HIPAA. Only required for non-exempt research.
Exempt research consent information sheet sample
DocuSign eConsent Work Instruction
Source Docs/CRFs Inclusion/Exclusion Checklist 21CFR §312.62
ICH E6 8.2.3, 8.3.2-3, 8.3.13-14
Blank Data Collection Sheets/Source Documents (Study specific. Both subject-facing (IRB approved) and non-subject facing.)
Advertisements/Recruitment Tools   Flier (Best practices from UF.) 45CFR §46.109
ICH E6 8.2.3, 8.2.7, 8.3.2-3
Template Phone Interview Invitation
Template Survey Invitation
Delegation of Responsibilities Log Template DOR Log (must match team members listed on IRB application)  ICH E6 4.1.5
ICH E6 8.3.24
Study Team (qualifications and certifications) Template Staff Human Subjects Research Training Tracking Log [no HIPAA] ICH E6 4.2.4
ICH E6 8.2.10, 8.3.5
Template Staff Human Subjects Research Training Tracking Log [+HIPAA]
Template Staff Protocol Training Log
Signed CVs (wet-ink or validated e-signature)
Staff Licenses (as applicable)
GCP Certifications
CITI Protection of Human Subjects (PHS) Certification (Group 1 or Group 2)
HIPPA 201 Certification 
HIPAA 125 Certification
Template Change in PI Letter- Minimal Risk Study
Template Change in PI Letter- Greater than Minimal Risk Study
Conflict of Interest Disclosures (if applicable) 
Lab Documentation     College of American Pathologists (CAP) Certificate (request from lab) ICH E6 8.2.11-12, 8.3.6-7
Clinical Laboratory Improvement Amendment (CLIA)- Certification (request from lab)
Lab Normals/Reference Ranges (request from lab)
Lab Director CV (signed and dated) (request from lab)
Lab Director Medical License (request from lab)
Study Sample Documentation   Template Sample Collection Log  ICH E6 8.3.25 
Template Sample Collection/Shipping Log
Screening and Enrollment Logs Template Screening and Enrollment Log ICH E6 8.3.20 & 8.3.22
Template Screening (only) Log
Template Enrollment (only) Log
Subject ID log Template Subject ID log ICH E6 5.5.5
ICH E6 8.3.21 & 8.4.3
Protocol Deviations  Template Protocol Deviation Tracking Log ICH E6 8.3.11 
AEs/UAPs    Template Subject AE Log  21CFR §312.32
ICH E6 8.3.16-17 
Template Protocol AE Log
Template Unanticipated Problem Form
Monitoring/QA/Audits   Template Monitoring/QA log 45CFR §46.111(a)(6)
ICH 8.2.19-20, 8.3.10, 8.4.4-5
Monitoring/Audit Reports
Data Safety Monitoring Template DSM Plan

45CFR §46.111(a)(6)
ICH E6 5.5.2;
ICH E6 8.3.18, 8.4.5
NIH DSM Policy

Template DSM Review Form
Template DSM Report (PI)     UMB HRPO tools and instructions 42CFR §11  
FDA Documents (Greater than Minimal Risk Research)         FDA Form 1572 21CFR §312
ICH E6 8.2.9, 8.3.4
FDA Form 1571
FDA Form 3455
FDA Form 3674 42CFR §11
FDA Form 3500A (Medwatch Form) 21CFR §312.32   
Template IND Tracking and Assessment Log
Template IND Serial Submission Log
Investigator Brochure/Package Insert IB/PI (Drug Studies only. Study Specific. Provided by the Sponsor. Provided in the IRB application.) ICH E6 8.2.1-8.3.1
Device Manual Device Manual (Studies with devices only. Provided by Manufacturer/Sponsor. Provided in the IRB application.) ICH E6 8.3.1
Investigational Product (IP) Records (Drug Studies only. Study Specific. Templates typically provided by the Sponsor and handled by pharmacy.)         Master Randomization List (if applicable)  ICH E6 8.2.18
IP Manual/Instructions  ICH E6 8.2.14
IP Shipping Records  ICH E6 8.5.15 & 8.3.8
IP Certification of Purity  ICH E6 8.2.16 & 8.3.9
IP Label 21CFR §312.6
ICH E6 8.2.13
IP Allocation and Decoding Procedures  ICH E6 8.2.17 & 8.4.6
IP Accountability Log, Temperature Log ICH E6 5.13.2
ICH E6 8.3.23, 8.4.1
IP Destruction Records 
Sponsor/Funder Communications  Emails, letters, grants, budget/contracts, etc. If kept electronically or in another location, a NTF may suffice. ICH E6 8.3.11, 8.2.4-6 
Certificate of Confidentiality Final Copy, if using NIH Notice Number: NOT-OD-17-109
Participant Payment Documentation UMB Participant Payment Log (Bottom of link) ICH E6 8.2.7
UMB VIII-99.00(B)
UMB Participant Cash/Card Count Form (Bottom of link)
UMB Financial Reconciliation Documentation (Bottom of link)
Participating Site Documentation   IRB Documentation 45CFR §46.107-108
ICH E6 8.2.8
Correspondence ICH E6 8.3.11
Data Use Agreements UMB IV-99.01(A)
Final Report Final Report and Raw Data (Raw data only if no separate subject binders.) 21CFR §312.62
ICH E6 8.2.3, 8.3.12-14
Notes-to-File (NTF) Template NTF ICH E6 8.3.15

Subject Binder Toolkit

Subject Binder ToolkitDocumentsSupporting Regulation
Progress Notes Template Progress Note 21CFR §312.62
ICH E6 8.3.13

Informed Consent Process Checklist 21CFR §312.62
45CFR §46.117
Evaluation to Sign Consent
Telephone Contact Form
21CFR §312.62
ICH E6 8.3.13
LAR Identification Form
Signed Informed Consent Document (non-exempt) ICH E6 8.3.12
Inclusion/Exclusion Checklist (Extract from approved IRB application) 21CFR §312.62
ICH E6 8.3.1
Subject Visit Materials Collected Original Data (Completed case report forms/source documents/data collection) 21CFR §312.62
ICH E6 8.2.3
8.3.2-3, 8.3.13