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 (Northwestern IRB)
Template Observational Protocol (UNC)
Template Biomedical Protocol (Northwestern IRB)
Template Clinical Trial Protocol (NIH)
CICERO Application (if using as your protocol)
Sample language available upon request via email NRSresearch@umaryland.edu.
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
Template External IRB Reliance Agreement/IAA Form
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
IRB Modification application
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
RNI Tracking Log
IRB Communications  Emails, hard-copy communications, etc. Appropriate to create NTF 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/HIPAA (Must be combined in one document if HIPAA applies, otherwise remove HIPAA at end.) If exempt research, information cover page with targeted info required (no need for full consent template).  45CFR §46.109
45CFR §46.116-117
ICH E6 8.2.3, 8.3.2-3, 8.3.13
Exempt research consent information sheet
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. 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/ Signature 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 (Qualifications from study inception to current)               Signed CVs for all study team members  ICH E6 4.2.4
ICH E6 8.2.10, 8.3.5
            
Staff Licenses (as applicable to study) 
GCP Certifications (all study teams members) 
CITI Responsible Conduct of Research (RCR) Certification (Group 1 or Group 2) 
HIPAA 201 Certification
HIPAA 125 Certification 
IATA Shipping Certification
Template Staff Protocol Training Log
Template Staff Training Tracking Log v.1 
Template Staff Training Tracking Log w/ HIPAA v.1 
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 (study inception to current)   CAP Certificate (College of American Pathologists- accreditation body)
Request from lab. 
ICH E6 8.2.11-12, 8.3.6-7
  CLIA (Clinical Laboratory Improvement Amendment- Certification in CLIA signals that specific federal standards are met)
Request from lab.
  Lab Normals/Reference Ranges (specific to lab)
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 (NIH) 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- UMB HRPP 
Template Unanticipated Problem Form (NIH) 
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 21CFR §312
ICH E6 8.2.9, 8.3.4
 
FDA Form 1571
FDA Form 3455 (Conflict of Interest Disclosure) 
FDA Form 3674 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. Study Specific. Provided by the Sponsor.)
Investigators Brochure  ICH E6 8.2.1-8.3.1
Device Manual
(Device Studies only. Study Specific. Provided by the Sponsor.)
Device Manual ICH E6 8.3.1
Investigational Product (IP) Records
(Drug/Device Studies only. Study Specific. 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 Participant Cash/Card Count Form
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