Regulatory Coordinator Toolkit

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Regulatory Start-up
Sample Study Startup Checklist	Use this checklist as a guide when planning startup activities. Note: All startup activities may not appear on the checklist. Revise as appropriate to meet the needs of your protocol and research site.
Clinical Trials Research Acronyms and Abbreviations	List of acronyms and abbreviations commonly used in clinical trial research.
Clinical Trials Glossary	List of terms commonly used in clinical trials research.
Glossary of Medical Terms in Lay Language	Helpful list of medical terms described in lay language.
Responses to Commonly Asked Questions on Sponsor Feasibility Questionnaires and Pre-Site Selection Visits	This tool provides guidance when completing Sponsor Feasibility Questionnaires and Pre-Site Selection Visits.
Investigator Site File Table of Contents	Template for Investigator Site file Table of Contents.
Regulatory Start-up - Essential Documents Checklist	ICH GCP E6 – 8.2
Regulatory Start-up - IRB Submission Documents	ICH GCP E6 – 3.1.2
Regulatory Start-up - IRB Submission Checklist	ICH GCP E6 – 3.1.2
Delegation of Authority Log	Use this log to document delegation of study related duties by the Principal Investigator to the study team. CH CGP E6 – 4.1.5 FDA Guidance for Industry – Investigator Responsibilities-Protecting the Rights, Safety, and Welfare of Study Subjects October 2009, Section III.A.1
Study Staff Training Log	Use this log to document study trainings (i.e., protocol training, amendment training, IP training, etc.) ICH GCP E6 4.2.4 FDA Guidance for Industry – Investigator Responsibilities-Protecting the Rights, Safety, and Welfare of Study Subjects October 2009, Section III.A.2
Study Contacts and Vendors List	List study team contact information and vendor information on this form.
Form FDA 1572	Website to download current version of Form FDA 1572.
Regulatory Maintenance
Regulatory Maintenance - Essentials Documents Checklist	ICH GCP E6 – 8.3
Regulatory Maintenance – IRB Submission Checklist	ICH GCP E6 – 3.1.2
Regulatory File Review Tool	ICH GCP E6 – 1.46, 1.47, 2.13
Corrective and Preventative Action Plan (CAPA) CAPA Plan Template	Corrective and Preventative Action Plan template
Regulatory Close-out
Regulatory Close-out - Essentials Documents Checklist	ICH GCP E6 – 8.4
Regulatory Close-out - IRB Submission Checklist	ICH GCP E6 – 3.1.2
Study Close-Out Checklist	ICH GCP E6 – 8.4
Other
eSignature via AdobeSign	21 CFR 11

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