Researcher Toolkit

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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 Section	Documents	Supporting 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 Review	IRB Initial Application (if you did not use CICERO as your protocol)	45CFR §46.109-110 ICH E6 8.2.7, 8.2.9, 8.3.4 UMB IV-2.10(A)
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 (non-exempt)	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
Case Report Form Templates	Blank Data Collection Sheets/Source Documents	21CFR §312.62 ICH E6 8.2.3, 8.3.2-3, 8.3.13-14
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
Study Sample Documentation	Template Sample Collection/Shipping Log	ICH E6 8.3.25
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/QA/Audits	Monitoring/Audit Reports	45CFR §46.111(a)(6) ICH 8.2.19-20, 8.3.10, 8.4.4-5
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	ICH E6 5.13.2 ICH E6 8.3.23, 8.4.1
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
Data Safety Monitoring (DSM)	Template DSM Report	45CFR §46.111(a)(6) ICH E6 5.5.2 ICH E6 8.3.18, 8.4.5
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 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	21CFR §312.62 45CFR §46.117
	Telephone Contact Form	21CFR §312.62 ICH E6 8.3.13
	LAR Identification Form	21CFR §312.62 ICH E6 8.3.13
	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

Quality Assurance (QA) Forms

Miscellaneous

Template Corrective And Preventative Action (CAPA) Plan