Phase I clinic automation, an innovative method combining e-source and e-CRF capabilities
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1
SGS Life Science, Clinical Pharmacology Unit , Belgium
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2
SGS Life Science, Datamanagement, Belgium
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3
SGS Life Science, Business IT , Belgium
The SGS Life Sciences Clinical Pharmacology Unit is equipped with a phase I clinic automation system that facilitates on-site electronic data capture. Upon data capture, sponsors and monitors have immediate access to the data and Data Management directly loads the e-source data in the SDTM compliant clinical database.
The requirements and expectations regarding the documentation of clinical trials data have historically grown in a context of source documentation and CRF transcription. In the same manner, the FDA guidance on Electronic Source Data in Clinical Investigations describes many e-sources (EHR, electronic laboratory reports etc.) and clearly differentiates these from the e-CRF, containing the auditable subject specific and per clinical trial protocol requested data.
These are important drivers for sponsors to request transcription into an e-CRF even when the phase 1 clinic automation system combines both e-source functionalities and setup functionalities to build and review forms per protocol.
Combining phase I clinic automation with CDISC standards in single site studies could be an innovative method of ensuring the most effective way to high quality study data. Bypassing the use of traditional or electronic CRFs will reduce site work as data transcription becomes redundant. Also from the CRO point-of-view the work diminishes drastically: all CRF development, user acceptance testing and source data verification efforts become zero. In addition the direct data transfer to data management, eliminating data transcription, ensures higher quality of the data.
Keywords:
ECRF,
SDTM,
eSource
Conference:
EUFEMED 2017, London, United Kingdom, 17 May - 19 May, 2017.
Presentation Type:
Poster
Topic:
EUFEMED 2017 CONFERENCE
Citation:
Vermeiren
K,
Sevenans
N,
Benoot
D and
Jansen
L
(2019). Phase I clinic automation, an innovative method combining e-source and e-CRF capabilities.
Front. Pharmacol.
Conference Abstract:
EUFEMED 2017.
doi: 10.3389/conf.fphar.2017.62.00005
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Received:
29 Aug 2017;
Published Online:
25 Jan 2019.
*
Correspondence:
Dr. Katrien Vermeiren, SGS Life Science, Clinical Pharmacology Unit, Antwerp, Antwerp, 2018, Belgium, katrien.vermeiren@sgs.com