Download Study Feasibility and Start-up

Study Feasibility and Start-up
Tiffany Morrison, MS, CCRP
Director, Clinical Trials
Rothman Institute
Learning Objectives
• Outline a few examples of things that are necessary to
consider when you’re assessing study feasibility at your site
• Explain why it is necessary to sign a CDA prior to initiating
contact with the Sponsor of a study
Startup Activities:
Image courtesy of CITI
Program Clinical Research
Coordinator course
Interest Letters/Feasibility Questionnaires
What are they?
What do you do with them?
Interest Letters / Feasibility Questionnaires
Inquiry from a Sponsor or CRO (Contract Research
Organization) to ascertain if there is interest and the
ability to participate as a site in a clinical trial
• Come in many forms with varying amounts of information
• Usually include a Site Selection and Feasibility Questionnaire
• Completed by the Investigator and/or the CRC
• Good practice to notify the Business Manager if interested
• http://www.dfhcc.harvard.edu/research/clinical-research-support/crs-searchresults/?tx_hcc_search%5Bquery%5D=feasibility+
Interest Letters / Feasibility Questionnaires
Sponsor Interested
Investigator Interested
Sponsor contacts the Investigator and coordinator listed
in Feasibility Questionnaire
Sponsor sends CDA (Confidentiality Disclosure Agreement)
and sets up a Site Selection Visit
Confidentiality Disclosure Agreement: CDA
Written agreement ensuring that investigators and/or
staff do not disclose the contents of the protocol or
proprietary information regarding the study.
• A legal document
• Needs to be reviewed by ORA / JCRI Business
Operations prior to returning to Sponsor (or sending
out in the case of IIT)
How to Read a Protocol (Quickly!)
Title
Table of Contents
Protocol Synopsis:
• Number of Centers (U.S. or worldwide?)
• Number of subjects
• Target population
• Objectives
• Treatment plan/duration
• Inclusion/Exclusion
Tables:
• Study Schema
• Study Events Table (read the superscript!)
Study Events Table Example
Study Schema Example
Assessing Protocol Feasibility
• The ability to enroll patients is paramount to success!
Adequate patient population?
Competing protocols?
Resources required to execute protocol activities available?
What information will be collected and how?
Additional training, space or equipment required?
Adequate availability of time; PI and CRC?
Opportunity for scientific publication or authorship?
Possibility of strengthened collaborations with sponsor for future
studies?
• Cost to conduct study versus proposed funding (if any)?
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Assessing Protocol Feasibility
• Is it necessary to collaborate with other departments for this
protocol?
• Microbiology: send protocol and make sure they’re able to
perform all necessary testing
• Investigational Drug Service: very important to bring IDS into
this process as early as possible
• IDS will determine if they’re able to prepare drug according to
protocol and will help work through logistics
• Radiology: MRI protocols, scanning protocols are often specific.
Need to make sure we’re capable of completing the radiological
section of the protocol
Site Selection Visit
• Aka Pre-Selection Visit (PSV)
• Not to be confused with a Site Initiation Visit (SIV)
• Sponsor will visit site to confirm facilities and staff are
adequate to perform protocol
• Will review the protocol, discuss any potential
obstacles, and confirm commitment
• Sponsor may collect some regulatory documents
(Investigators CV and license, lab certificates, etc.)
• Make sure you schedule time with additional
Departments, as necessary
Next Steps! Clinical Research Pre-Award Process
• IRB Submission and JCRI Business Operations Submission are Parallel Processes
Application
IRB
Contract
Approval
Letter
Budget
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