Transcript Starting A Clinical Trial

How to Start An Industry
Sponsored Clinical Trial
Lynda Lane, MS, RN
Administrative Director, GCRC
Starting A Clinical Trial
Confidentiality Agreement
Study Synopsis
Protocol Evaluation and Feasibility
Site Selection Visit
Confidentiality
Agreement
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The clinical agreement is between
Vanderbilt University, by and
through its Medical Center and the
Sponsor
Key Points in a
Confidentiality Agreement
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The sponsor wants to assure you will
not share their protocol with others.
You need to avoid agreeing to terms
you cannot satisfy.
Study Synopsis
An overview of the study that includes the
following:
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Protocol Number
Title
Study Phase
Objectives
Study Design
Subject Population
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Inclusion Criteria
Exclusion Criteria
Duration of Subject
Involvement
Duration of Study
Statistical Methods
Protocol Evaluation &
Feasibility
The protocol is evaluated to determine if the study
center and/or principle investigator have the resources
to complete the proposed study, including:
Qualified Personnel
Equipment
Facilities
Access to the required subject population
Is the project of benefit to the Principle Investigator
and institution
Protocol Evaluation
Protocol Contents
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Title page
Table of contents
Introduction
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Study Design
Objective
Experimental Design
Patient Selection
Statistical Analysis
Adverse Events
Subject Withdrawal
Drug Accountability
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Discontinuation of Study
Data
Disclosure/Publication
Documentation
Project
Timetable/Flowchart
References
Appendices
Site Selection Visit
The site selection visit allows the sponsor to:
Evaluate
the ability of a study site to
successfully conduct the proposed clinical trial
Evaluate
the credentials of study personnel
Evaluate
the adequacy of clinic facilities.
Site Selection Visit
Issues Reviewed
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Investigator Brochure.
Protocol.
IRB issues.
Laboratory issues.
Drug storage and
accountability.
Source document
requirements.
Site Selection Visit
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Discuss monitoring visits.
General clinic operations.
Responsibilities of study personnel.
Available regulatory
documents provided.
Tour clinic facility.
Tour investigational drug pharmacy
You are ready to start
enrolling when
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The sponsor gives you the go ahead
You have all IRB and regulatory
documents completed and approved.
You have all supplies and meds.
You have all case report forms.