Professionals in the fields of Data Management, Biostatistics, and Clinical Programming create critical data, records, programs, and outputs that support the conduct and the analysis of the data collected for a clinical study. These data, records, programs, and the output created are Trial Master File (TMF) content and fall into the overall process requirements for its management. Data Managers, Biostatisticians, and Programmers have critical roles in a company’s meeting the regulatory requirements for management of the TMF so that they can successfully undergo audits and inspections.
This half-day training will provide a light review of TMF management principles with a special emphasis on the topics that impact functions involved in collecting, managing, analyzing, and reporting clinical study data. The CDISC TMF Reference Model will be reviewed, spotlighting the full Zones 10 (Data Management) and 11 (Biostatistics) with deeper dives into specific data and record types. Data and the intersection of the TMF with digital data flow will be briefly reviewed during the training.
After completing this training, the Data Manager, Biostatistician, and Programmer will be more knowledgeable about their contributions to their company’s achieving TMF excellence and regulatory compliance both during and after the conduct of the study. Join us to enhance your TMF management skills and ensure robust regulatory compliance. Don't miss out—secure your spot now!
Audience: This training is not intended for TMF professionals unless they wish to learn focused TMF management principles from a data (Zone 10 and 11) perspective.
Please Note: Due to high interest but smaller cohort sizes, TMF Excellence training sessions are scheduled based on participant demand. Please use this Waitlist Form to indicate your interest in a future TMF Excellence session. Once we reach the minimum number of 10 participants, we will confirm a session and contact you with next steps. Submitting this form does not require payment and does not guarantee enrollment, but it ensures you’ll be notified as soon as a session is confirmed.
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