How to Ensure Study Compliance and Integrity through Training and Delegation of Authority
Speakers:
- Wendy Tate, PhD, MS, Director of Data Analytics, Nimblify
- Mariette Marsh, MPA, CIP, Director of the Human Subjects Protection & Privacy Program, University of Arizona.
Location: Penn State Hershey Medical Center Hershey, PA, Support Service Building, Room 206
***Remote viewing also available. Please email the Chapter at CNEPA@acrpnet.org after registering for link.Registration Fee: Free and open to all to attend.
Program Agenda:
- 3:15pm-3:30pm – Registration & Cookies
- 3:30pm-4:30 pm – Educational Presentation and Discussion
Program Description: According to the FDA and OHRP, the Principal Investigator (PI) is responsible for all study conduct. However, in the day of complex study designs it is impossible for the PI to directly conduct all aspects of a research study. Therefore, qualified and reliable staff must be employed to ensure the study is carried out according to the protocol. Attendees of this webinar will understand the regulatory requirements of investigator oversight, as well as gain tips for ensuring investigators are properly engaged with delegated duties; study staff entrusted with study conduct are properly trained; and delegation of authority documentation is maintained.
Upon completion of this Webinar Replay, attendees should be able to:
- Describe the investigator’s responsibility for study conduct and explain the delegation of authority process
- Explain how to obtain and maintain ethically responsible delegation of authority
- Implement a system to document delegation of authority in a regulatory-compliant manner.
Target Audience: Investigators, Clinical Research Staff and Administrators, Clinical Research Coordinators, Clinical Research Associates, Clinical Project Managers, Human Subject Protection Office personnel, Research Quality Assurance staff and anyone working in clinical research.
Contact hours: 1 Contact hours have been applied for through ACRP. Membership is not required for online registration of contact hours.
To receive contact hours: Purchase the contact hours, sign in at the registration desk, and attend the program. Log on to the ACRP website then “ACRP Learning Portal” to complete the evaluation no later than 30 days following the event and obtain the online certificate.
Contact Hour Cost:
- $0 Chapter Members
- $15 ACRP Members
- $30 Non-Members
Refund Policy: There are no refunds unless the program is cancelled by the chapter before the start of the program.
Level: Intermediate
Further Information: CNEPA@acrpnet.org or Kevin Gardner
kgardner@pennstatehealth.psu.edu