Sponsor Expectations for Clinical Studies at Thomas Jefferson University
This presentation discusses the sponsor expectations for clinical studies, investigator responsibilities, TJU's strengths in conducting studies, and how principal investigators can impress sponsors. Topics include assessment of investigator performance, regulatory guidelines, streamlining processes, flexible IRB, and the importance of meeting enrollment expectations for investigators and institutions to be considered for future studies.
- Clinical Studies
- Investigator Responsibilities
- Sponsor Expectations
- Thomas Jefferson University
- Clinical Research
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Presentation Transcript
Sponsor Expectations for Clinical Studies Stephen Workman, MPH September 2016 Thomas Jefferson University
Objectives Investigator responsibilities Sponsor assessment of PI performance What TJU does well How PIs can be more impressive to sponsors
Investigator Responsibilities Governed by: Code of Federal Regulations, Title 21 Part 11 Electronic records & signatures Part 50 Protection of human subjects Part 54 Financial disclosure Part 312 IND ICH guidelines for good clinical practice
Sponsor assessment of performance Evidence of PI involvement Conversant regarding progress of study Exhibits familiarity with subjects status, condition, compliance Awareness of severity, causality, resolution of AEs/SAEs Progress notes, lab reports signed within reasonable timeframe Assessing PI involvement Conversation are stories consistent? Is communication candid or guarded? Can PI discuss key information (e.g., SAEs) without prompting by SC or other staff?
What TJU does well Streamlined processes Flexible IRB Frequent meetings (3 panels; 5 meetings per month) Can accommodate sponsor-mandated text Has process to resolve issues after two non-approvals Ability to outsource to contract IRB Result = Rapid start-up
How PIs can be more impressive Enrollment is a key measurement of investigator performance Inability to meet enrollment expectations is a principal reason that a sponsor will not consider an investigator or an institution for subsequent studies
How PIs can be more impressive Provide a conservative estimate of subjects who can reasonably be expected to qualify and consent to participate; work as hard as possible to meet or exceed your objective.
