Validating electronic source data clinical trials
In 2006, the Electronic Source Data Interchange (e SDI) Group within CDISC issued a paper entitled “Leveraging the CDISC Standards to Facilitate the use of Electronic Source Data within Clinical Trials.” The e SDI document was the product of the CDISC e SDI Initiative, the purpose of which was “to investigate the use of electronic technology in the context of existing regulations for the collection of e Source data (including that from e Diaries, EHR, EDC) in clinical trials for regulatory submission by leveraging the power of the CDISC standards, in particular the Operational Data Model (ODM)." The overall goal of the initiative was to make it easier to collect data once in an industry standard format. 29, 2014, FDA addressed these issues in a webinar reviewing the final guidance for industry titled “Electronic Source Data in Clinical Investigations." Presenters included Leonard V.Sacks, associate director, Office of Medical Policy (CDER), Ron Fitzmartin, Office of Strategic Programs (CBER), and Jonathan S.The requirement by EMA of ICH E6 of an independent contemporaneous investigator copy (ICIC) of the case report form (CRF) has led to numerous and passionate debates among the professional and industry associations.
If this is not possible the chronology of events should be recorded.Helfgott, associate director for risk science (acting), Office of Scientific Investigations (CDER).Clearly, FDA is supporting efforts by industry to adopt e Source solutions.According to the EMA, the source data and their respective capture methods should be clearly defined prior to trial recruitment (i.e.in the protocol or study specific source data agreement).
As a result of this lack of consensus of the regulatory understanding of how to optimally generate and review electronic source records, apprehension and uncertainty among solutions vendors, contract research operatives, and pharmaceutical company sponsor remains.