Regulatory Education for Industry (REdI): FDA & MHRA Good Clinical Practice Workshop: Data Integrity in Global Clinical Trials – Are We There Yet? October 23-24, 2018
- October 23-24, 2018
- October 23, 2018
October 23-24, 2018
Registration and Agenda
This event is free to the public. You may attend in-person or via webcast. Please see attendee notes below for more information about in-person registration.
Tommy Douglas Conference Center (TDCC)
10000 New Hampshire Avenue
Silver Spring, MD 20903
Regulatory agencies conduct Good Clinical Practice (GCP) inspections to verify the reliability of data generated in clinical trials and adequacy of human subject protection, in addition to ensuring that clinical trials are conducted according to the applicable regulations. In this era of globalization of clinical trials, regulators have increased collaboration to evaluate the adequacy of clinical trial conduct to optimize regulatory resources and oversight.
This workshop will provide US Food and Drug Administration, Center for Drug Evaluation and Research (CDER) and Medicines and Healthcare products Regulatory Agency UK (MHRA) perspectives on the importance of quality management practices on data reliability. It will provide regulatory perspectives on data management, data blinding to minimize introduction of bias, and the role of audit trails in assessing data integrity in global clinical trials. The workshop participants will have opportunities to work on relevant case studies on these topics.
At this event, participants will learn:
- Regulatory perspectives on importance of quality management systems on data reliability
- How data management practices may impact data reliability
- Impact of data blinding on data reliability
- How audit trails may be used to assess data integrity
- How to evaluate data integrity/reliability using case examples
Who Should Attend?
- Clinical Quality Assurance Professionals
- Clinical Operations Professionals
- Data Management Professionals
- Clinical Trial Electronic Systems Developers
- Clinical Trial Statisticians and Statistical Programmers
- Clinical Investigators and Clinical Investigator Site Staff
- Regulators- GCP inspectors
- Regulators- Reviewers/Assessors of Clinical Trial Data
FDA & MHRA Resources
- CDER: Office of Scientific Investigations
- CDER: Office of Study Integrity and Surveillance
- Medicines & Healthcare Products Regulatory Agency
Notes for Attendees
- Registration will be capped at 150 attendees.
- Please do not request in-person participation unless you are certain you can commit to traveling to Silver Spring to attend both days.
- Due to limited seating, everyone expressing interest in attending may not be able to participate in-person. We will establish a waitlist and notify participants if cancellations occur.
- Confirmation of in-person participation will be provided by via email by 9/24/2018.
- Confirmation of in-person attendance is recommended prior to making travel plans
- Attendees requesting in-person participation will still be able to attend the day one webcast if not confirmed to attend in-person.
- Participants will view the first day of lectures on a live webcast and participate remotely.
- On the second day of the workshop, there will not be a live webcast.
- Virtual attendees will be provided only the case studies and subsequent regulatory analysis.
Continuing Education (CE)
This event is eligible for up to nine credits towards a RAC certification. Only in-person attendance will qualify for the CE. Attendance certificates are only available for two weeks after the event.
This event will be recorded and made available to registered attendees after its conclusion. Any information shared publicly by participants during the event will become part of that recording. This includes the verbal questions and answers sessions.