Researcher Toolkit

UMSON

• Monthly Research Seminars and Recordings
• UMSON Human Subjects Research Training Requirements
• UMSON Research Policy:  Human Subjects Scientific and Feasibility Review
• UMSON Research Policy: Education and Oversight Requirements
• UMSON CICERO User Registration Instructions
• UMSON Non-Human Subjects (NHSR) Submission Guidance
• External IRB (SMART IRB) Work Instructions
• Informed Consent Simplificiation Guide
• Procedures for Submission of Human Subjects Research Protocols to UMB's IRB

UMB

• UMB Research Policies

UMB Human Research Protections Office (HRPO)

• UMB HRPO IRB Resources for Researchers
• UMB HRPO Investigators Manual
• CICERO Instruction Videos
• Clinical Research Training Mentoring Program Request Form

UMB Conflict of Interest Office

• UMB Conflict of Interest Office Website

UMB Research Integrity Office

• UMB Research Integrity Office Website
• Research Integrity & RCR Training
• Expedited vs. Exempt vs. NHSR Presentation
• Clinicaltrials.gov Resources

UMB Office of the Controller

• UMB Policy on Participant Payments
• Tango e-Cards

UMMS

• UMMS Resources for Researchers
• UMMS Research Investigator Submission Packet (UMMS review required if research involves UMMS sites/resources outside of UMGCCC)
• UMMS Research Policies and Procedures

UMGCCC

• UMGCCC Study Start-up Procedures (GCCC review required if research involves UMGCC sites/resources)

Federal

DHHS

• Clinicaltrials.gov
• Clinicaltrials.gov Taskforce
• US DHHS Clinical Trials Registration and Results Information Submission (42CFR §11)
• US DHHS Code of Federal Regulations (45CFR §46)
• Minimal Risk Exempt Categories (45CFR §46.104)
• Minimal Risk Expedited Categories
• NIH Data Management and Sharing Policy Info and Resources
• NIH Policy and Guidance for Data and Safety Monitoring
• NIH email RE: DSM Plan Guidance Minimal Risk Non-Exempt Research
• Office of Human Research Protections (OHRP) Training Videos
• NIH Notices

FDA

• FDA Code of Federal Regulations -Protection of Human Subjects (21CFR §50)
• FDA Code of Federal Regulations -Electronic Records, Electronic Signatures (21CFR §11)
• FDA Code of Federal Regulations -Investigational New Drug Application (21CFR §312)
• FDA Guidance on Clinical Trials during COVID-19 

International

• International Conference on Harmonization (ICH) E6 (R2) Guidelines

 

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.

• Minimal Risk (MR) -Exempt TOC
• MR-Expedited (non-exempt) TOC
• Greater Than Minimal Risk (GTMR) TOC 
• Veeva SiteVault eRegulatory Binder TOC - Coming soon

 

Regulatory Binder Section	Documents	Supporting 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)
ClinicalTrials.gov	UMB HRPO Clinicaltrials.gov 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	Documents	Supporting 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 (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

• UMB HRPO PI QA Checklist
• QA Self Assessment Form (MR Exempt)
• QA Self Assessment Form (MR Expedited)
• QA Self Assessment Form (GTMR)
• QA Self Assessment Non-FDA Regulated
• Template Corrective And Preventative Action (CAPA) Plan