Structure and Organization of Research at TJU Kathleen

Structure and Organization of Research at TJU Kathleen

Structure and Organization of Research at TJU Kathleen OMalley RN, BSN, CCRP Manager of Education and Training Jefferson Clinical Research Institute [email protected] Stephen Klasko, MD, MBA President and CEO of TJU AND Jefferson Health System Working toward reunification of TJUH and TJU into a single Academic Medical Center 2 Pillars of the Unified Academic Medical

Center 4 Pillars: Goal: Jefferson Health System at the forefront of patient care, basic and clinical research, education and innovation Clinical Academic Researc h Innovation Foundatio n Clinical Research Organizational

Chart: Mark Tykocinski, MD Provost and EVP, Academic Affairs Dean, Sidney Kimmel Medical College David Whellan, MD, MHS Associate Provost for Clinical Research, Director JCRI Laura Vinci, RN, MBA Senior Director Clinical Research Operations JCRI Ron Polizzi, MBA Director Business

Operations Paul Park Manager, Clinical Research Systems Suzanne Adams, RN, MPH Director Clinical Operations Kathleen O'Malley, RN, CCRP Manager

Education Training Theodore Taraschi, PhD Research Integrity Officer Walter Kraft, MD Director of OHR Brian Squilla, MBA Chief of Staff Vice President for Administration Tim Schailey, Director of ORA

Sam DiIanni, Director of RACE Kyle Conner, MA, CIP Associate Director, OHR 4 Reorganizing Clinical Research at Jefferson: JCRI Processes

SOPs Planning Office of Human Research Marketing Monitoring JeffTrial Business Operations Training Regulatory

Central Clinical Research Infrastructure for all of research SKCC CTO 5 OHR and the offices they work with: Research Administration & Research Administration Center of Excellence Office of

University Counsel Corp. Compliance & HIPAA Office of Research Planning Environmental Health Services & Institutional Biosafety Committee Office of Animal Resources

Office of Human Research Department & Committee Prereview of IRB Submission Office of Radiation Safety Clinical Trials Office Investigational Drug Service Sidney Kimmel

Cancer Center Jefferson Clinical Research Institute 6 Who is doing research at Jefferson? The Sidney Kimmel Medical College of TJU Jefferson College of Biomedical Sciences Jefferson College of Health Professions Jefferson College of Nursing Jefferson College of Pharmacy Jefferson College of Population Health Jefferson Health Systems TJUH

Jefferson Hospital for Neuroscience Methodist Rothman Institute Abington Wills Eye Institute Currently not operating under the Jefferson Federalwide Assurance (FWA) 7 Responsibilities of the Research Team Need sufficient study staff to perform clinical research efficiently and effectively: Appropriate skill set and training GCP (Good Clinical Practice) standards Follow protocol requirements

8 Who makes up the research team? Principal Investigator (PI) Sub Investigator (Sub I) Clinical Research Nurse Coordinator (CRNC) Clinical Research Coordinator (CRC) Regulatory Coordinator Key Personnel 9 Principal Investigator: An individual who conducts a clinical investigation or, in the event of an investigation conducted by a team of individuals, is the responsible leader of the

team. 10 Principal Investigator Responsibilities 21 CFR 312.60: An Investigator is responsible for ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations; for protecting the rights, safety and welfare of the subjects under the investigators care; and for the control of the drugs under investigation Protocol compliance IRB review &

approval Informed consent prior to study procedures Record keeping and retention Adverse event reporting Control of investigational drug

Integrity of data/inspectio n of records 11 Principal Investigator: Responsibilities of investigators can be found in the following sections of the regulations: -IND trials: 21 CFR 312 subpart D -IDE trials: 21 CFR 812 subpart E and subpart G -21 CFR 50 (informed consent requirements) -21 CFR 56 (IRB requirements) -ICH E6 Guidelines 4.1- 4.13 The investigator must also be aware of any local rules or regulations in addition to those outlined in the CFR. 12

Investigator Statement: Form FDA 1572 A contract between the Sponsor and the investigator in which the investigator agrees to comply with the protocol and all regulations pertaining to clinical research Signed before a clinical trial involving an investigational drug or biologic can begin Not a regulatory requirement, but used frequently in IND (investigational New Drug) studies Investigators participating in IDE (Investigational Device Exemption) studies do not complete a Form FDA 1572, but similar information is collected by the Sponsor -sometimes called an Investigator Agreement 13 http://www.fda.gov/downloads/AboutFDA/Report sManualsForms/Forms/UCM074728.pdf

Principal Investigator Investigators must understand and adhere to Responsibilities federal regulationsits the law! The regulations are in place to protect the RIGHTS, SAFETY and WELFARE of study subjects. 15 Clinical Research Coordinator: manages and conducts the day-to-day study activities in accordance with the protocol, applicable regulations and GCP requirements. Vital to the success of a trial Come from a variety of backgrounds 16

The responsibilities of the CRC have expanded to beyond the clinical management of subjects to much more sophisticated expertise in compliance, research administration, marketing, fiscal and legal activities Adapted from the CTSA Research Coordinator Taskforce Critical Needs for CRC Training Support and Career Development 17 slides January 11-12, 2011 Image courtesy of the Joint Task Force for Clinical Trial Competency (JTFCTC) What makes a successful CRC?

Attention to Detail Excellent communication skills Flexibility Ability to work independently Organizational skills Grit / Can-do attitude 19 Additional Research Personnel: Sub-investigator: A member of the research team designated and supervised by the PI to perform critical study-related procedures and/or to make important study-related decisions The FDA regards sub-investigators as those individuals authorized to make medical judgments and decisions regarding study subjects CRNC: Clinical Research Nurse Coordinator

Certain protocol-related activities may require a license or certificate of training (ex. administration of medications or Glasgow Coma Scale) 20 Additional Research Personnel: Regulatory Coordinator/Specialist: Prepares and maintains IRB submissions and Regulatory documents Tracks study progress in Clinical Trial Management systems (Portal and JeffTrial) Key Personnel: Personnel considered to be of primary importance to the successful conduct of a research project IRB Policy G 601 http://www.jefferson.edu/content/dam/tju/human_research/irb/documents/PolicyandProceduresManual/20150528%2 0DO%20NOT%20MODIFY%20Policy%20and%20Procedure%20Manual%20COMPLETE%20CLEAN.pdf

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