Clinical Data Management and CDISC Standards

Many pharmaceutical and biotechnology companies are working on the development of new drugs, compounds and devices for betterment of human health and increase the quality of life globally. This process of drug development and discovery when reaches the stage of testing in human volunteers involves people from various specialty and varied background. Final goal of any human trial is to be able to investigate the safety and efficacy of the investigative compound or device in human subjects within the regulatory guide-lines and accepted standards of safety, patient care and data interpretation.

The initial stage of any clinical study involves the collection of observational, laboratory and other data of the trail subjects and is the most critical part in the study life cycle. It is this collected data, which will be used in analyses of final end points of any study. The quality of data and accuracy then becomes most important thing. The greater the ambiguity of collected data the faster will be the analyses of the study objectives. The role of Clinical Data Management becomes very critical in this aspect.

Coming to modern time the paper CRF’s became the de-facto mode of collecting the observational data for any clinical trial. This collected data then reaches the Clinical Data Management department. The main role of CDM is to verify the accuracy of the data and correct any ambiguity in it. This process would involve many back and forth communication with the concerned investigative sites until 100% data is reported clean.

Now we have many good clinical data management systems which gather the source data from these paper CRF’s. But in spite of having these systems there is still a gap in global standardization in data naming conventions and a wide array of different forms and formats are being used to collect clinical trial information into these CDMS systems. Many organizations have developed their own processes and procedures. This has resulted in data being collected and submitted to regulatory bodies in various formats and which in turn made the whole process of clinical study life cycle less streamlined and resulted in delays in many of the components of drug discovery and clinical trial process. In order to create a global standard in how the data should be collected and submitted to regulatory bodies, the CDISC then took the initiative to bring consensus on the standardization of not only in the submission data but also, in the very source of data collection into clinical trial management systems (CDMS). First step in this direction was to come up with the standards and format in which the final data to be submitted to regulatory authorities. Study Data Tabulation Model (SDTM), Operational Data Model (ODM) were the first steps from CDSIC in this direction. CDISC has worked with the FDA to assist in the development of a complete electronic medical research process. In 2006 the FDA adopted the CDISC Study Data Tabulation Model (SDTM) for electronic submissions as cited in the Electronic Common Technical Document (eCTD). The second scenario involves only the submission of data to regulatory bodies in SDTM format. The last one would involve only the CDMS data collection in SDTM standard.