CDISC StandardsSeptember 7, 2013 2013-09-07 19:38
Electronic data submission is the prospect of clinical studies and assessors will shortly have the legal authority to refuse submissions that do not comply with expectations. CDISC Standards are intended to overpower the impending problem of electronic data submission in coming future.
CDISC is a universal, non-profit, free, multidisciplinary entity that has come-up with standards to aid the collection, transfer, submission and archive of clinical trial data and metadata. The CDISC job is to build up and maintain worldwide, platform-independent data exchange standards that facilitate information system interoperability to advance medical research and related areas of medicine. Below mentioned are few CDISC standards for reference.
Protocol Representation Model The Protocol Representation Model (PRM) is deliberated to be a template that voluntarily facilitates protocol developers to enter relevant information from a protocol such that it can be effortlessly reused in the future, e.g. for clinical trial registration and regulatory submissions.
Study Data Tabulation Model (SDTM) – Customized content of CRF tabulations used for data exchange and regulatory submissions.
Standard for Exchange of Non-clinical Data (SEND). Both SDTM and SEND fall under submission domain standards (SDS).
Analysis Data Model (ADaM) – Standardized information of analysis data sets used for data exchange and clinical submissions. It was designed specifically for analysis of clinical data.
The Operational Data Model (ODM) is intended to make possible the archive and interchange of the data and metadata for clinical research, its power can be fully exploited when data are gathered from multiple locations.
Laboratory Data Model (Lab) – This model is considered to handle simple lab data.
The industry is inescapably moving toward necessary adaptation of widespread standards for data structure, restricted terminology and content. It is now upon all caught up in clinical research work to cuddle this emergent body of global industry standards and make sure homogeneous implementation for each submission to regulatory bodies. Apparently, CROs profit significantly by streamlining their procedures and increasing efficiencies and uniformity of execution across all clinical studies regardless of sponsor by embracing CDISC Standards.