Protocol |
Template Chart-Review Protocol |
ICH E6 8.2.2 & 8.3.2
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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
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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) |
Smart 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 |
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Clinical Laboratory Improvement Amendment (CLIA)- Certification (request from lab) |
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Lab Normals/Reference Ranges (request from lab) |
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Lab Director CV (signed and dated) (request from lab) |
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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 |
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Correspondence |
ICH E6 8.3.11 |
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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 |