This course explores the international challenges of trial records management: people, culture, and systems. With so many trials occurring in Brazil, Russia, India, China, South Korea and Turkey, as well as the US, Canada and Europe, the confluence of cultures presents unique challenges. This course offers suggestions for building a workable, sustainable system for clinical documents and data with practical templates, processes and solutions to common problems. This course also reviews the range of documentation that sponsors and sites need to control and generate for a successful outcome. It also addresses what to do with records once a trial is complete.
This course has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for 12 credits towards a participant's RAC recertification upon full completion.
Who Should Attend
Conducting clinical trials and accruing accurate and viable data is the most expensive component of the drug development paradigm. Clinical teams are held accountable to ensure the most efficient and effective delivery of high quality data from each and every trial that they complete. Even in this day of electronic data transfer for many aspects of a trial, how those data are collected, reviewed, archived and retrieved has become a logistical nightmare for many clinical teams. This course aims to support all those team members who touch some aspect of clinical documentation in understanding the importance of the data/paper flow based on the specifics of their clinical protocol and existing systems.
Typical attendees include:
- Project Managers, Directors and Leaders
- CRO Staff Members
- Site and Sponsor Staff Members
- Clinical Investigators and Study Coordinators
- Clinical Operations Directors and Senior CRAs
- Clinical Trial Managers, Monitors and Associates
- Medical Affairs and Clinical Operations Professionals
- Quality Assurance Personnel
- Central Records Staff
- Document Management Staff
- Regulatory Managers
Companies in the business of conducting clinical trials must understand that each trial is different and requires trial-specific processes for gathering data, managing it, transporting it to the right place and archiving it. Trials require a complete web-work of documents and records, from contracts, protocols, investigator brochures, and standard operating procedures, to data collected during the conduct of the trial and transmitted to the Sponsor for analysis and regulatory use. Even if a Sponsor has a robust document management system, to be successful, a clinical trial must address records management unique to the study itself and incorporate the various resources allocated to the conduct of the trial. By the end of the course, participants should be able to do the following:
- Understand the documentation requirements for a trial based on the protocol and the geographical location
- Review and assess documentation needs in the context of paper, electronic and hybrid document management systems
- Understand the roles and responsibilities of the team members with regards to the trial documentation; understand those roles from the Sponsor, site and CRO perspective
- Determine what SOPs are required to run the trial and who has responsibility for them
- Know what the Essential Document list should be for the protocol you are testing
- Understand what the Trial Master File is made of and how this is different from the Essential Document list
- Be prepared for audits; site, CRO and in-process trial audits