To maintain the integrity of data, the CDM process starts at the very beginning of a clinical trial, even before the study protocol is finalized. The CDM team designs a case report form (CRF) and defines the data fields to be utilized. CRFs specify the type of data to be collected, the units of measurement to be used, and CRF completion guidelines (i.e., instructions for filling in data). Variables are annotated using coded terms.
A data management plan (DMP) is then developed as a guide, including a description of the trial’s CDM activities. Databases are built to support CDM tasks with corresponding compliance tools. Testing is done before using the plan with actual clinical trial data. CFR tracking, data entry, validation, discrepancy management, medical coding, and database locking are subsequent steps in the process.
Case report forms may be used to collect data by paper or electronic means; however, as technology has continued to evolve, the trend towards electronic data collection has followed suit. Furthermore, remote data entry or e-CRF has been adopted by many pharmaceutical companies as a time-saving measure.