1. Getting a study done at Jefferson:

2. Startup Activities: Image courtesy of CITI Program Clinical Research Coordinator course

3. Interest Letters/Feasibility Questionnaires What are they? What do you do with them?

4. 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+ http://www.dfhcc.harvard.edu/research/clinical-research-support/crs-search- results/?tx_hcc_search%5Bquery%5D=feasibility+

5. 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

6. 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

7. 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)?

8. 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

9. 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

10. Next Steps! Clinical Research Pre-Award Process 10 Application IRB Contract Budget Approved IRB Submission and JCRI Business Operations Submission is a Parallel Process Approval Letter