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
May come via or snail mail.
May include a protocol synopsis or general information regarding the study.
This is the Sponsor’s opportunity to evaluate the Investigator, the Site and Resources to see if they can be successful in enrolling patients and completing the protocol as written. Also the Site’s opportunity to sell themselves as a desirable site.
See hyperlink for good example. (Also saved to desktop…hopefully!)

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 / JCRI Business Operations prior to returning to Sponsor (or sending out in the case of IIT)
Mention Ron Polizzi will be presenting to follow

7. 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!)

8. Study Events Table Example

9. Study Schema Example

10. 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)?
This is the PI or Site assessing the ability to get the study done and if it meets their needs.
If so, then fill out sponsor feasibility questionnaire and return.
This is very different than evaluating and negotiating the budget.

11. 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

12. 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

13. Next Steps! Clinical Research Pre-Award Process
IRB Submission and JCRI Business Operations Submission are Parallel Processes
Approved
Application
IRB
Contract
Budget
Approval Letter
Approved
Approved