How to Start An Industry Sponsored Clinical Trial

1. How to Start An Industry Sponsored Clinical Trial Lynda Lane, MS, RN Administrative Director, GCRC

2. Starting A Clinical Trial Confidentiality Agreement Study Synopsis Protocol Evaluation and Feasibility Site Selection Visit

3. Confidentiality Agreement • The clinical agreement is between Vanderbilt University, by and through its Medical Center and the Sponsor

4. Key Points in a Confidentiality Agreement • The sponsor wants to assure you will not share their protocol with others. • You need to avoid agreeing to terms you cannot satisfy.

5. Protocol Number Title Study Phase Objectives Study Design Subject Population Inclusion Criteria Exclusion Criteria Duration of Subject Involvement Duration of Study Statistical Methods Study SynopsisAn overview of the study that includes the following:

6. 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

7. Title page Table of contents Introduction Study Design Objective Experimental Design Patient Selection Statistical Analysis Adverse Events Subject Withdrawal Drug Accountability Discontinuation of Study Data Disclosure/Publication Documentation Project Timetable/Flowchart References Appendices Protocol Evaluation Protocol Contents

8. 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.

9. Site Selection VisitIssues Reviewed • Investigator Brochure. • Protocol. • IRB issues. • Laboratory issues. • Drug storage and accountability. • Source document requirements.

10. Site Selection Visit • Discuss monitoring visits. • General clinic operations. • Responsibilities of study personnel. • Available regulatory documents provided. • Tour clinic facility. • Tour investigational drug pharmacy

11. You are ready to start enrolling when • 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.