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.
Course Type
Private
Public
Virtual Classroom
Course Length
1/2 Day
Course Link
The Critical Role of Data Managers, Biostatisticians, and Programmers in Achiev…