Getting a study done at Jefferson:

Startup Activities:

Image courtesy of CITI Program Clinical Research Coordinator course

Interest Letters/Feasibility QuestionnairesWhat are they?What do you do with them?

Interest Letters / Feasibility QuestionnairesInquiry 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: CDAWritten 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

10

Appl

icatio

n

IRB

Contract

Budget

Approved

Approved

Approved

• IRB Submission and JCRI Business Operations Submission is a Parallel Process

Approval Letter