Analyzing the Cra and the Data Management Plan

¶ … CRA and Data Management Plan

CDM (Clinical Data Management) is the control/management of the collection and processing of data in the conduction of clinical trials. CDM involves the following; the design of the instrument to be used in the collection of data; the collection of data; quality control processes; and database consolidation. The design, testing and implementation of a Data Management Plan (DMP) require the participation of all stakeholders including; the main clinical associates, managers, project managers, sponsors and regulators among others (Gupta & Institute of Clinical Research (India), 2011).

CDM is an important phase of clinical research that leads to high quality, statistically correct and reliable data for clinical trials. This allows scientist and researchers to significantly reduce the time taken in drug development or in assessing various clinical outcomes. Clinical trial is an exercise in which a hypothesis is either proved or disapproved by generating data to answer a research question. Data generated when testing new devices or drugs on humans is referred as clinical data. The proper management of this data from its collection to its processing is an essential element in the process of preparing a regulatory submission and getting approval to commercialize a medication (Prokscha, 2011). CDM has transformed from being a simple clerical task in the early eighties to being a specialization handled by professional CRAs (Clinical Research Associates). CRAs have been tasked over the years with adapting emerging forms of data management and processing to CDM.

Components

Clinical research is a critical element in the drug development process owing to the fact that it allows researchers to show the reproducibility of results and effectiveness of the drug. CDM may be required together with complete documentation when seeking for approval from regulators, for example the FDA who will use it to recreate the trial and the results submitted. Regulators use the data provided CRAs to assess the efficacy and safety issues related to a particular drug class to which the treatment being proposed belongs to. The review and approval of new drugs or forms of treatment by regulatory authorities are anchored on the belief that clinical data presented are of adequate integrity. The integrity of the results ensures that the data and the conclusions reached by the sponsor organization can be trusted and used in making final decisions. Key to obtaining that trust is the demonstration of adherence to safety and quality standards. This is where CRAs are important. Clinical research associates are employed by companies involved in the drug development process so as to guarantee the integrity of the results. Sponsor companies must also ensure that apart from the CRAs, all the other employees involved in the drug development process are qualified and have sufficient experience to perform the tasks they are assigned. In the DMP, development commences after the drafting of protocol and CRF (case report forms). CRFs must be constantly updated so as to ensure that important adjustments to the data management systems are recorded (King, n.d).