Getting a study done at Jefferson:

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-search-results/?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
Assessing Protocol Feasibility
• The ability to enroll patients is paramount to success!
• Adequate patient population?
• Competing protocols?
• Resources required to execute protocol activities available?
• 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)?
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 is a Parallel Process
ved
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ppr
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IRB
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Application

ppr
A Approval
Letter
Contract ed
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Budget

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