Case report forms (CRFs) are the tools used in clinical trials to collect data about subjects from investigator sites. Whether a CRF is paper or electronic, it must translate the clinical protocol in such as way as to collect data that will support the planned analyses. The CRF must also accommodate the many problems that arise in the "real world" of the clinical sites and subjects.
The course begins with a discussion of how to map a clinical study protocol to a CRF structure. After laying out the skeleton of the CRF, we design individual modules or pages with text and fields to collect data. These are chosen to aid compliance with the protocol, produce analyzable data, and improve data-processing and data-cleaning efforts. The class will view and discuss many concrete examples and options for CRF modules that demonstrate how the CRF impacts all of the groups involved in the conduct of the clinical trial.
This class is designed for clinical data managers, clinical research associates, and other clinical staff who might be involved in CRF development.
Familiarly with the fundamentals of clinical trials, either from experience or the "Drug Development Process" course.
