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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.

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As usage of CommCare for data collection in clinical trials grows over time, the investment required for setting up a validated CommCare environment may be justified and the manual validation step canLeveraging the CDISC Standards to Facilitate the use of Electronic Source data within Clinical Trials. 
17-Oct-2018 09:43
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Data validation scheduling Data Validation Plan. information entering into an electronic database from paper CRFs by two independent inputs. providing trainings on filling and maintaining eCRFs to the users. EDC users support. loading data from external sources. 
17-Oct-2018 09:48
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Clinical data management CDM is a critical phase in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials. Clinical data management assures collection, integration and availability of data at appropriate quality and cost. 
17-Oct-2018 09:51
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Good Clinical Practice GCP • Trial management; data handling, record keeping 2.10, 5.5.3 a-d. • Subject and data confidentiality 2.11; 5.5.3 g.• Site records data from source documents to the electronic database or the web interface. • Data periodically electronically transmitted to. 
17-Oct-2018 09:55
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Clintrial, the market's leading Clinical Data Management System CDMS. Oracle Clinical or OC is a database management system designed by Oracle to provide data management, data entry and data validation functionalities to Clinical Trials process.18. 
17-Oct-2018 10:00
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US FDA Guidance for Industry. Electronic Source Data in Clinical Investigations. No. BPP-Lib-071eCRF is an auditable electronic record of information that generally is reported to the sponsor on each trial subject, according to a clinical investigation protocol. 
17-Oct-2018 10:04
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Abstract. Clinical trials constitute a key source of medical research and are therefore conducted on a regular basis at university hospitals. Tasks that are essential for efficient data management in clinical trials include the following the design of the trial database, the design of electronic case. 
17-Oct-2018 10:08
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Validating electronic source data clinical trials introduction

Validating electronic source data clinical trials

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