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 NRSResearch@umaryland.edu for specific questions or to provide feedback.

Guidance and Training

UMB and UMSON

Federal

Regulatory Binder Toolkit

Regulatory Binder Checklists and Template Table of Contents

Regulatory Binder SectionDocumentsSupporting Regulation/Guidance
Protocol Template Chart-Review Protocol ICH E6 8.2.2 & 8.3.2



Template Social/Behavioral Research Protocol
Template Observational Protocol
Template Biomedical Protocol
Template Clinical Trial Protocol
CICERO Application (if using as your protocol)
Template Protocol Version Tracking Log
IRB Information UMB IRB Roster

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

UMB IRB FWA
Site Reliance Agreement (between a site that has an IRB and a site that does not have an IRB)
Template External IRB Reliance Agreement/IAA Form (between two sites that each have an IRB)
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)
IRB Modification Approval (the IRB/HRPO approval document)
IRB Modification Page (the modification application page "front end" - where the changes are described)
IRB (CICERO) Modification Application (the CICERO application "back end" - 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 UMB IRB RNI Criteria 21CFR §312
45CFR §46.108
ICH E6 8.3.11, 8.3.16-17
RNI submissions and acknowledgements (the copy of the RNI submission and the HRPO/IRB determination letter)
RNI Tracking Log
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/HIPAA (or information sheet if applicable in exempt research)  UMB Template Consent and HIPAA Consent (Not necessary for Exempt Minimal Risk categories; must be combined in one document if HIPAA applies, otherwise remove HIPAA at end) 45CFR §46.109
45CFR §46.116-117
ICH E6 8.2.3, 8.3.2-3, 8.3.13
Consent Information Sheet Example for Minimal Risk Exempt Studies (no need for full consent template)
COVID Risk Statement (the UMB standardized COVID-19 risk language for in-person research)
Template Informed Consent Tracking Log v.1
Case Report Form Templates 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
Advertisements/Recruitment Tools   Flier (example) 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 v.1.1 (must match team members listed on IRB application)  ICH E6 4.1.5
ICH E6 8.3.24
Study Team Documentation  Signed CVs (wet-ink or validated e-signature) ICH E6 4.2.4
ICH E6 8.2.10, 8.3.5
            
Staff Licenses (as applicable) 
GCP Certifications
CITI Protection of Human Subjects (PHS) Certification (Group 1 or Group 2)
HIPAA 201 Certification
HIPAA 125 Certification
Environmental Health and Safety Lab Certifications (as applicable)
Template Staff Protocol Training Log (through life of study)
Template Study Team Training Tracking Log
Template Study Team Certification Tracking Log Non-HIPAA
Template UMB SON Change in PI Letter- Minimal Risk Studies
Template UMB SON Change in PI Letter- Greater than Minimal Risk Studies
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 Log
Template Enrollment Log
Subject ID log Template Subject ID log ICH E6 5.5.5
ICH E6 8.3.21 & 8.4.3
Protocol Deviation/Violations  Template Protocol Deviation Tracking Log ICH E6 8.3.11 
AEs/UAPs    Template Subject Adverse Event Tracking Log v.1.1  21CFR §312.32
ICH E6 8.3.16-17 
  
Template Protocol Adverse Event 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
FDA Documents (Greater than Minimal Risk Research)         FDA Form 1572 (Statement of the Investigator) 21CFR §312
ICH E6 8.2.9, 8.3.4
 
FDA Form 1571 (Investigational New Drug Application)
FDA Form 3455 (Conflict of Interest Disclosure) 
FDA Form 3674 (certification of clinicaltrials.gov compliance) 42CFR §11
FDA Form 3500A (Medwatch Form) 21CFR §312.32   
Template IND Tracking and Assessment Log v.1
Template IND Serial Submission Log v.1
ClinicalTrials.gov     Checklist for evaluating whether a clinical trial or study is an applicable clinical trial (ACT)  42CFR §11  
clinicaltrials.gov instructions
clinicaltrials.gov checklist 
Investigator Brochure/Package Insert
(Drug Studies only. Provided by the Sponsor.)
Investigators Brochure  ICH E6 8.2.1-8.3.1
Device Manual
(Device Studies only. Provided by the Sponsor.)
Device Manual ICH E6 8.3.1
Investigational Product (IP) Records
(Drug/Device Studies only. Templates typically provided by the Sponsor.)         
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 ICH E6 8.2.7
UMB VIII-99.00(B)
UMB Participant Cash/Card Count Form
UMB Financial Reconciliation Documentation
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)
Data Safety Monitoring (DSM) Sample Data Management Plans 45CFR §46.111(a)(6)
ICH E6 5.5.2
ICH E6 8.3.18, 8.4.5  
Template DSM Report
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
Screening




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 21CFR §312.62
ICH E6 8.3.1
Subject Visit Materials Completed case report forms/source documents/data collection- subject specific 21CFR §312.62
ICH E6 8.2.3
8.3.2-3, 8.3.13