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
At the present time the Office of Licensing is handling confidentiality agreements.  Contact Brian Laden and he can assist you with these.  I think that the Licensing Office will give you a quick turn around.  You and the PI should not sign these, acknowledge that you agree to the terms and conditions and get an official institutional signature. 

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. Study Synopsis An overview of the study that includes the following:
Inclusion Criteria
Exclusion Criteria
Duration of Subject Involvement
Duration of Study
Statistical Methods
Protocol Number
Title
Study Phase
Objectives
Study Design
Subject Population
A condensed version of the protocol

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. Protocol Evaluation Protocol Contents
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
Clinical Trial Protocol Format
Title page
Includes the protocol title, product name, IND number (if applicable), author/sponsor/monitor names, investigator name/site, IRB name/address, protocol date; may also include signatures of investigator/sponsor representative.
Table of contents
Introduction
Includes a detailed description of previous pre-clinical and/or clinical studies involving the compound or device to be studied.
Objective
A concise statement of the goal(s) of the current study.
Experimental Design
A synopsis of the operational aspects of the study, including type of study, number of patients/subjects, control compound(s), duration of treatment, laboratory studies etc.
Patient Selection
A comprehensive list of inclusion and exclusion criteria, screening procedures etc.
Study Design
A detailed description of all procedures to be performed on the study patient and the schedule for each.
Statistical Analysis
A statement of the types of data to be analyzed and, to the extent possible, the statistical methods to be employed.
Adverse Events
A description of the procedures for receiving, evaluating and managing reports of adverse events of any type and degree of severity.
Subject Withdrawal
A description of conditions under which patients may withdraw from and/or be withdrawn from the study and procedures for their replacement (if applicable).
Drug Accountability
A detailed description of the manner in which clinical supplies will be packaged, including randomization schemes, label contents, coding etc.
Case Report Forms
Description of and instructions for completion and review of Case Report Forms.
SOP No. 002 Effective Date: 11/11/02
Appendix
Clinical Trial Protocol Format (cont’d)
Informed Consent
Instructions for obtaining legally valid written informed consent from each prospective study patient/subject.
Institutional Review Board
Information concerning the requirement for prior approval of the protocol and the Informed Consent form as well as continuing contact between investigator and the IRB.
Discontinuation of Study
A statement that the Company may discontinue study at any time and a description of any actions that may follow such discontinuation of clinical approach, numbers of subjects/patients, time frames, previous study data etc.
Data Disclosure/Publication
A statement of Company policy regarding publication or other disclosure of the data collected during the study.
Documentation
A list of documents and data required to be provided to the sponsor before, during and after the study (optional).
Project Timetable/Flowchart
A graphic or tabular depiction of the procedures and chronology of the study.
References
(optional).
Appendices
Tables, Figures, descriptions of special procedures etc. (optional).

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 Visit Issues Reviewed
Investigator Brochure.
Protocol.
IRB issues.
Laboratory issues.
Drug storage and accountability.
Source document requirements.
a. Investigator Brochure.
* Review history of development of the drug/product.
* Review format of the brochure and how to locate specific information. Review major preclinical and clinical findings.
SOP No. 014 Effective Date: 11/11/02
b. Protocol.
* Objectives.
* Study design.
* Inclusion/exclusion criteria.
* Study procedures.
* Schedule of visits/exams/tests.
* Schedule for patient recruitment.
* SAE reporting.
c. IRB issues.
* Review informed consent requirements (CFR 50.25).
* Discuss original IRB approval of protocol and informed consent and requirements for periodic reports and renewals.
* Review ongoing IRB reporting requirements.
• Protocol amendments.
• Advertising.
• SAEs.
d. Laboratory issues.
* Local laboratory.
• Review procedures for collection of specimens and obtaining/reporting results.
• Discuss turn-around time for laboratory reports.
• Obtain laboratory certification and reference ranges.
• Review QA/QC procedures.
– Instrument calibration.
– QC charts for controls.
– Instrument maintenance logs.
– Determine requirements for additional laboratory accreditation.
– Tour lab facilities.
* Central laboratory.
• Discuss arrangements with central laboratory.
• Discuss procedures for completing laboratory requisition forms and for obtaining, preparing and shipping specimens.
* Review special laboratory assays and procedures.
e. Drug storage and accountability.
* Clinic site storage.
• Discuss storage capability—must be locked area with limited access.
• Discuss special storage requirements—shelf, refrigerated, frozen (if frozen, check for consistent temperature verified by QA charts or thermometer).
• Review standard dispensing and accounting procedures.
* Pharmacy storage.
• Meet pharmacist; view storage area.
• Discuss special storage requirements.
f. Source document requirements.
* Review standard clinic/hospital record to determine adequacy of source documents for the proposed study.
* Discuss any inadequacies of documentation and additional requirements for the study.
* Discuss requirements for retention of study documents for two (2) years following date of FDA approval of study product or (2) two years following date study is completed/terminated/ discontinued.
* Discuss procedure for making changes to CRF and source documents.
g. Monitoring visits.
* Review requirements and procedures for and frequency of routine monitoring visits.
* Discuss expectations for visits.
* Discuss source document review and data queries.
* Discuss possibility of QA audits of site.
h. General clinic operations.
* Review clinic schedule—hours of operation, days for patient visits.
* Discuss procedures for patient recruitment and follow-up.
* Discuss procedures for locating and documenting patients lost to follow-up.
* Review general work flow and patient flow for the clinic.
* Determine if support staff is available to study personnel.
* Determine if clinic has equipment necessary to perform the study.
i. Responsibilities of study personnel.
* Review overall responsibilities. Assess ability of site to accommodate the proposed clinical trial.
* Review individual responsibilities of study personnel for proposed trial.
* Determine if there are ongoing, competing clinical trials.

10. Site Selection Visit General clinic operations.
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.