Principal Investigators (PIs) are required to provide adequate oversight of all clinical research activities at the site, whether the activity is conducted by the PI, by study team members, or by applicable third parties. Adequate oversight encompasses many activities and obligations, such as ensuring regulatory compliance, staff training, and subject medical care. In this web seminar, we will discuss the regulatory requirements and guidance regarding adequate investigator oversight and appropriate delegation of study tasks, review documentation requirements, and determine strategies for appropriate delegation of tasks.
- Recognize the industry concerns about adequate delegation and improper delegation of study activities
- Identify documentation requirements for proper delegation and investigator oversight
- Identify strategies for determining role assignment specific to a study project and requirements of PI oversight
- Site Research Managers
- Clinical Research Associates/Monitors
- Study/Clinical Research Associate Managers
- Clinical Research Coordinators
Nikki Christison, B.S., C.C.R.A.
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Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for pricing.
Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 1.5 hours (0.15 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion. ACPE#: 0778-0000-14-061-L01-P. Released: 9/14.
Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.