Participants at this training will review the good clinical practice (GCP) definitions and regulations for research data management and define source documentation and list examples. The presenter will discuss the types of essential documents as described in ICH GCP 8. The presenter will list how essential documents are maintained by the site and/or sponsor throughout the course of the trial and will outline the guidelines for data quality (ALCOA) and discuss source document creation, case report forms, electronic data entry, research charts and EMR as source documentation. Additionally, those attending will be able to prepare and organize regulatory file materials, subject files and identify deviations to appropriate management of data and files. By the end of the training, you should be able to summarize regulatory requirements for management of research documents and subject records; identify GCP essentials documents appropriate for the trial being conducted; and identify investigator responsibilities for recording and maintaining source data/documentation.
Credit Offered: PSNA
Registration:
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