By Raymond Nomizu, JD, CEO & Co-founder at CRIO
In the current model, clinical research sites collect source data, which is the data collected contemporaneously with the protocol-prescribed procedures, and then transcribe this data into the electronic case report forms (eCRF) housed in an Electronic Data Collection (EDC) system provisioned by the sponsor. This transcription is not contemporaneous and can lag weeks and even months. The source data is then reviewed and confirmed directly by the Clinical Research Associates (CRAs aka “monitor”), and the EDC data is reviewed and queried by the Data Managers. After the EDC is locked, DMs will extract the data for statistical analysis.
These paper templates will vary from site to site. The templates are written as workflow tools to enable the site to collect data properly.
With paper, the site’s data collection process is highly error prone; for instance, in the above template the site might mis-record the date of the procedure, record the wrong arm, leave a field blank, forget to initial and date, or record a signature (attribution) date inconsistent with the vitals date. All of these are potential findings that the CRA will flag for corrective action, as part of the sponsor’s obligations to ensure quality and patient safety across the trial.