This package is a replay of the ACRP 2021 Virtual Program. It includes the following sessions:
Explore key opportunities for the clinical research industry to make the FDA inspection experience a positive one. Hear inspections’ impact on applications and identify key strategies to build quality into clinical research in order to prevent critical compliance issues. When problems do occur, inspected entities should be able to respond appropriately. Take away practical approaches to working with the FDA during an inspection, responding to 483s after an inspection, and responding to subsequent regulatory correspondence. Speaker: David Burrow, PharmD, JD, Director, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, FDA
Explore what it takes to be ready for the figurative knock on the door from FDA. Examine FDA Inspections and how to prepare for the inevitable knock, discuss available resources, and review responses received from 483s. Speaker: Eric Pittman, Director, Bioresearch Monitoring Division (West), FDA
The first right of the patient after consenting to participate in a clinical trial is the right to withdraw this consent. However, a consent withdrawal may have several forms and consequences, and understanding the underlying reasons behind a consent withdrawal may affect the steps to be implemented for a proper follow-up and return to routine practice. This session will bring communication keys to site personnel to properly interact with patients willing to opt-out from a trial, taking into consideration safety aspects, protocol compliance, and data protection aspects. Speaker: Hubert Lesur, CCRC, CCRC, GCP-QA Auditor, HL Health Support
Conflict happens in all clinical trials management setting. Having a self-awareness and ability to recognize them and how to negotiate will make the workplace stronger. This session will help you to identify strategic advantages to help you to deal with conflict management in your professional setting. We will explore tools to utilize to resolve conflict. Our goal is to help you to compare your style of conflict and negotiation styles so you can better impact the action plan with better outcomes. Speaker: Dr. Kelly Willenberg, DBA, RN, CCRP, CHC, CHRC, Manager, Kelly Willenberg & Associates
Get an overview of the definitions and requirements for registration and submission of results requirements to ClinicalTrials.gov. This session will also describe FDA’s role in the compliance and enforcement of ClinicalTrials.gov, as well as a review of available FDA resources for those involved in ClinicalTrials.gov clinical trials. Speakers: Miah Jung, PharmD, Pharmacologist, FDA and Jan Hewett, BSN, JD, Regulatory Counsel (Policy), FDA CDER
The most stressful moment in a site’s research experience just might be the first time you learn that you’ve been selected for an FDA inspection. Panic from not knowing what to expect may hinder an organized and thoughtful approach to preparing for and hosting that inspection. But, what if an institution that has 4-6 inspections every year shared their experiences, and how, in response to those experiences, they now plan and prepare for, host, and manage post-inspection responsibilities? This session will examine just that! This session will demystify the inspection process from a site perspective and give your site a confident and organized plan to manage your first – or next – FDA inspection. Speaker: Neala Lane, MS, CCRC, Associate Director, Quality Improvement Office Indiana University
As the clinical research industry struggles to determine how, or if, to move forward with clinical trials based on the potential hazards related to exposure to COVID-19, the continued protection of the rights, safety, and welfare of participants must still be the primary consideration. However, even without the added safeguards required during this time, the FDA has historically noted that IRBs are not meeting their regulatory obligations and that Sponsors and Clinical Investigators are not assessing their compliance. As Good Clinical Practice is based on shared responsibilities for ensuring credible data from protected subjects, when an IRB is not compliant, neither are the Sponsors and Clinical Investigators. Examine the requirements for a compliant IRB, methods for assessment, and discuss processes to ensure compliance, collaboration, and communication. Speaker: Elizabeth Nelson, President, Regulatory Risk Management, LLC
It is difficult to manage protocol deviations and ensure appropriate corrective and preventive action items are implemented by research sites, and the difficulty increases with the complexity of trial designs. This educational session will present a solution for implementing a CAPA strategy specifically to address protocol deviation management. Sponsor operations teams and clinical research site personnel will benefit from learning practical ways to manage deviations and reduce the risk of further deviations. Speaker: Mindy Ditch, MS, President and Founder, Bloom Clinical Research, LLC
This interactive program is designed for regulatory professionals who deal with complex issues, need to understand the latest developments, and can contribute their own front-line experiences. We will cover important GCP topics and preparation for audits and regulatory inspections. Bring your own GCP questions and dilemmas. Speakers will employ hands-on activities to create corrective and preventive Actions (CAPAs), utilizing root cause analysis (RCA) procedures to address FDA citations in warning letters and 483s. Speakers: Janet Holwell, CCRC, CCRA, TIACR, FACRP, Independent Consultant and Glenda Guest, CCRA, RQAP-GCP, TIACR, President NCRA