Investigator Oversight Plans: Essentials for Inspection Readiness Post ICH GCP E6 (R2) Addendum
$279.00 – $2,550.00
Investigator Oversight is essential to running an effective, compliant clinical trial. New ICH GCP E6 (R2) guidelines suggest changes in how this should be done. Join us for this interactive session to learn more.
The ICH E6 GCP update sets clear expectations that investigators will have oversight procedures in place that assure human subject protection, data integrity, and investigational product control. These updated expectations come in response to global audit findings related to investigator lack of oversight of delegated tasks over direct and indirect study site staff. It is essential that trial site culture include a proactive approach to trial management to support anticipation of problems and the ability to establish effective issues management.
The clinical trial space has not been successful in improving the overall performance of investigators in this regard. Sponsors’ adoption of a risk-based monitoring approach will improve the oversight of the sponsor, while ensuring effective investigator oversight or management of critical issues for positive inspection findings and efficient process for trial management.
Join us for this 60 minute interactive webinar to identify the essential information you need to understand and implement effective and consistent investigator oversight in clinical trials, including which components of a site quality system and clinical trial execution plan must be in place. You and your colleagues will be taken through a clinical trial case scenario applying an investigator oversight plan.
By attending this interactive live session, you will be able to:
- Define investigator oversight.
- Learn what ICH GCP E6 (R2) means for investigators and oversight.
- Identify essential site procedures for investigator oversight.
- Practice implementing an investigator oversight plan.
WHO SHOULD ATTEND
This course will be valuable to anyone working in clinical trials. Specifically, this course will be of greatest benefit to those working in clinical operations, clinical quality, and monitoring roles. Additionally, this session will be of value to investigators and those who work in trial management, plus anyone who is affected by the quality of trial performance.
WHAT TO EXPECT
HOW TO PARTICIPATE
This webinar is offered on-demand. With your course purchase, you may view the previously recorded live session at your convenience (available for 30 days). Access to the on-demand webinar will be made available via email within 1 business day after your purchase. To access the course, you need only a computer with internet access and the log-in credentials.
THE TRAINING PLATFORM
Our webinar platform combines the convenience of online training with the live interactivity of the classroom. Quizzes, case studies, break-out sessions, and assessments are often incorporated into the training . Other ancillary materials can be downloaded from the “Handouts & Resources” area in the virtual classroom. Each course purchase includes a completion certificate issued to the participant after the course.
Your registration fee for a single participant entitles you to one telephone dial-in and one online course log-in per site. Course testing capabilities, stored results for training records, and completion certificates are available for only one registrant per single participant course purchase. For multiple participants, please purchase more than one registration or consider our 5 or 10 participant packages.
Is this course right for me? We’d be happy to help you select the right training course to meet your needs.
Give us a call at 215-675-1800 and use Option 3 (9am – 5pm EST, M-F) for assistance.
Single Participant, 5 Participant Value Package, 10 Participant Value Package