Pharma / Biotech
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.
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:
Case Study Exercise
Essential Documents & Trial Master File
Trial Conduct – Managing the Day-to-Day Documents
Continuing Case Study Exercise
GCP Audits – Before, during and after the Trial
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:
"This course was really helpful for me. The additional material and examples shared with the class will be really helpful to implement a better control of the TMF. The Course Director welcomed our opinions and questions, she was always willing to give us her valuable point of view." Alicia Huidobro, Head of Documentation, Probiomed S.A. de C.V
"Excellent course! With the material provided, I can implement in practice what has been learned." Aaron M., Clinical Research Department, Probiomed
"I have enjoyed all of my courses with CfPIE. The knowledge I have received in all my courses has helped me tremendously." Barbara K., MCA Compliance & Tracking Coordinator, Smith and Nephew
"I thoroughly enjoyed this training. It satisfied all my needs and answered previously un-answered questions. The Course Director has a natural talent to present this class and masterfully guided it along. The group members were fantastic! The location was great as well." Tanya B., Records Analyst, Cephalon
"I felt that the course director was very knowledgeable, professional, and friendly. Kay's extensive knowledge and willingness to share was not only refreshing and unexpected, but inspiring." Fatima S., Document Manager, Novartis Pharmaceuticals
"I loved the course and the instructor. Class interaction was great and I learned a lot from fellow class members, as well as from the course director. I would highly recommend this course." Carol S., Sr. TMF Manager, UCB
"Very informative, I learned so much to take back to the workplace!" Brenda H., Manager, QA Operation, Pfizer
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The Center for Professional Innovation and Education (CfPIE) provides technical training for Pharmaceutical, Biotech, Medical Device and Skin/Cosmetics professionals. CfPIE offers more than 350 class sessions annually across 80 course titles in multiple formats, such as classroom, on-site and certification programs.
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