Description:
This is a Research Coordinator Series Workshop that we are now pleased to now offer to the entire Penn State research community! Participants will review the good clinical practice (GCP) definitions and regulations for research data management and define source documentation and list examples. Presenters will discuss the type of essential documents as described in ICH GCP 8. The presenters 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.
Objectives:
- Summarize regulatory requirements for management of research documents and subject records.
- Identify GCP essentials documents appropriate for the trial being conducted.
- Identify investigator responsibilities for recording and maintaining source data/documentation.
Credit Offered: PSNA