Standardizing Principal Investigator Delegation Records: An Alternative Approach for Sites
Presented by: Nadine Nemunaitis and Staci Horvath of Mary Crowley Cancer Research Centers
PI delegation documentation can be a challenge to maintain due to turnover or position / function fluctuations within the research site. Using sponsor provided paper logs for delegation records can be burdensome for site operations.
This session will discuss an alternative strategy for documenting PI delegation using an alternative strategy that has proven to support the balance of site operations in managing these fluctuations, while still meeting the regulatory requirements related to documenting delegation.
After watching this webinar, you'll learn:
- Discuss the guidance related to PI Oversight as it relates to Delegation Responsibilities
- Examine Sponsor / CRO methods of delegation documentation and the impact for the clinical sit
- Recommend tools and strategies to overcome operational challenges that may exist with the methods above
About Nadine Nemunaitis - Nadine Nemunaitis is the Vice President of Research Operations for Mary Crowley Cancer Research Centers (MCCRC). She has worked in the clinical research industry for 22 years. In her current role at MCCRC she oversees the Human Research Protections Program (HRPP). Encompassed within the HRPP is Mary Crowley’s Central IRB, as well as the division of Research Operations which includes the following departments: Study Development, Project Management, Quality Assurance, Data Management and Site Management. Throughout her professional career, she has prepared for and represented Principal Investigators in the conduct of 12 FDA Site audits and has represented an Institution / Central IRB in the conduct of 6 FDA IRB audits. Her primary mandate is to apply expertise gained from these experiences in carrying out Mary Crowley's mission to expand treatment options for cancer patients. She is committed to ensuring this mission is achieved in compliance with federal regulations and national standards, state and local laws, as well as institutional policies.
About Staci Horvath - Staci Horvath has been working in the Clinical Research field for 15 years. She joined the field in a regulatory affairs position. After gaining 4 years of experience in that area, Staci moved into the clinical setting working on NIH funded trials. While there was still a small regulatory component involved, most of the experience gained in that position was patient focused. Staci then had an opportunity to expand on that experience by working again with FDA regulated studies for which Staci was able to get back into an advanced regulatory affairs role as well as continue working with patients and gain experience with contract / budget negotiations and research finance accounting. These positions provided an array of experience in site operations that led to a successful and smooth transition into a Research Operations Management and Project Management position with Mary Crowley Cancer Research Centers for a number of years before entering her current position as the Director of Operations for the Mary Crowley CRO. In this role, she oversees the operations of Mary Crowley CRO and is responsible to ensure the effective execution of projects managed by the CRO, in compliance with the FDA Code of Federal Regulations (CFR), the ICH Good Clinical Practice (GCP) Guidelines, as well as OHRP/DHHS guidelines.