4: Data Collection and Reporting

Use CDISC standards to support data collection and reporting with a focus on data aggregation for the purposes of scientific investigation and comparative effectiveness

Other Information:

With increasing demands for aggregated data for comparative effectiveness evaluations, biosurveillance and drug safety surveillance, the knowledge base supporting pharmacovigilance data is growing. There are increasing pressures to enhance the access to information for such purposes to improve evaluations of safety and efficacy for biopharmaceutical products and other therapies. Requirements are generated at the legislative level as well as from regulatory authorities. CDISC has an opportunity to leverage its experience to great advantage. The use or application of existing CDISC standards can contribute to several key domains, including biomedical research, adverse event reporting, post-marketing pharmacovigilance, and potentially certified supply chain documentation. Coordination with regulatory agencies is paramount, but support of other co-existing standards is essential for success. Appropriate areas of expansion for CDISC may included: a) the implementation of the CDISC Integrating the Healthcare Enterprise (IHE) Retrieve Form for Data Capture (RFD) integration profile to support drug safety reporting, clinical research, and population of registries using EHRs (through the CDISC Healthcare Link Initiative), b) the FDA Integrated Safety Data pilot and c) the harmonization of AE standards, including National Institutes of Health (NIH) and cancer Bioinformatics Grid (caBIG) models into BRIDG. These should be areas of focus for TAC and our EHR/HIT programs. CDISC should remain both agile and forward-looking in support of the evolving, complex environment. Since one of the principle benefits of the use of consistent standards is the ability to aggregate and "re-use" data, this feature will be highlighted to stakeholders in the execution of this part of the strategy.

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