Webinar Duration: 60 minutes

RECORDED: Access recorded version only for one participant; unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of payment)

SPEAKER: Grace Morgan Holmes

Protocols are living documents that are often routinely amended throughout the life of a clinical trial. Due the ever-fluid nature of a protocol’s evolution, as well as the potential errors and lack of clarity that they sometimes can possess, it is not surprising many of the issues cited in protocol audits and FDA inspections are noted protocol deviations and violations.

It can be difficult for clinical trial team members to determine whether protocol deviations occur, and can be even more intimidating to team members to determine how to address the deviations when they know that there may be repercussions for them. By learning how to approach identifying, classifying, and reporting deviations and violations per regulatory and trial specific requirements, clinical trial team members can learn to become more confident in being able to handle the uncomfortable task of protocol deviation management.

Why should you Attend: When conducting clinical trials, sites, sponsors, and contract research organizations (CROs) often find themselves in a position in which an identified issue may instead be a protocol deviation. For some, it can be difficult to determine whether an error in study conduct or administration is just an error, a protocol deviation, protocol violation, or an issue of intentional non-compliance.

Additionally, those less familiar with the process of identifying protocol deviations may also not be able to easily determine the impact of the deviation on the clinical trial conduct a both the site and study levels. Furthermore, clinical trial team members may struggle with the process of reporting deviations to the appropriate entities, including Sponsors, Institutional Review Boards/Ethics Review Boards, and regulatory entities.

Creating an effective management strategy for identifying, documenting, resolving, and reporting protocol deviations can be greatly beneficial to providing clinical trial team members with the appropriate tools to handle this daunting task.

At the completion of the webinar, attendees should be able to:
– Know what a protocol deviation is and how it differs from simple clinical trial conduct errors, protocol violations, and non-compliance
– Understand the implications of protocol deviations from a regulatory perspective
– Identify protocol deviations and violations in real time and determine how they have impacted study conduct on a site-specific and global study perspective
– Be familiar with reporting requirements for sites, Sponsors, and regulatory entities
– Determine whether the impact of the identified protocol deviation or violation requires additional follow up, and what tools can be used to ensure that the deviation does not happen again
– How effectively documenting and identifying protocol deviations and violations is an essential part of a clinical trial’s quality management system

Areas Covered in the Session:
– Describe what protocol deviations are. Give examples. Also, explain the differences between deviations vs. non-compliance and violation, and simple clinical trial site or sponsor errors. This will include references to the CFR and ICH
– Discuss why it is important to identify deviations, and how they can be classified (e.g. by impact/severity; site vs. global perspective)
– Break down the process of identifying protocol deviations; and what clinical trial teams should do once they are discovered. This will involve reviewing a “protocol deviation lifecycle”, from identification through IRB/regulatory authority acknowledgement/resolution. It will also bring into light how managing protocol deviations properly is an important part of the QMS
– This section will review the importance of adequate documentation when handling deviations from the site, Sponsor, and IRB/EC perspective
– I will include a few examples of deviation scenarios, and ask the attendees to tell me how they would handle this situation. I want this to be a more interactive webinar
– This section will address how not properly managing deviations can lead to problems in the immediate and near future.I will use a few examples

Who Will Benefit:
– Study Coordinators
– Clinical Site Monitors/Clinical Research Associates
– Study Managers at site, CRO, and Sponsor Levels
– Regulatory Associates and Managers
– CROs and Sponsors

Grace Morgan – Holmes is a regional clinical research associate with years of experience managing, supporting, and monitoring clinical research. Ms. Morgan-Holmes currently acts as a Senior Clinical Research Associate, CRA trainer, Quality Control monitor, and Protocol Specialist at Westat, a Contract Research Organization based in Rockville, Maryland. Previously, Ms. Morgan-Holmes has acted as a clinical study coordinator, in-house CRA, and clinical study manager. Ms. Morgan-Holmes has experience in clinical study design, clinical study coordination and project management, site monitoring, budget and contract preparation, preparation and implementation of training programs, development of standard operating procedures and work instructions, coordination of research publications, statistical analysis, and technical writing. In addition, she is familiar with International Conference on Harmonisation, U.S. Department of Health and Human Services, and Food and Drug Administration clinical research requirements and privacy policies.