Recorded as final against the primary source on 1 August 2026.
The text that supported that record, retrieved 1 August 2026 by pdf:
consultation 4 March 2021 Start of public consultation 18 June 2021 End of consultation (deadline for comments) 17 December 2021 Final version adopted by the GCP IWG 7 March 2023 Date of coming into effect 6 months after publication This guideline replaces the ‘Reflection paper on expectations for
Each format carries the permalink and the date this instrument was observed. The
observation date is part of the citation: the underlying source may have changed
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Plain text
GxPlex. EMA guideline on computerised systems and electronic data in clinical trials [instrument record]. Observed 1 August 2026. https://gxplex.com/instrument/ema-ct-computerised-systems Primary source: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf
BibTeX
@misc{gxplexinstrumentemactcomputeriseds,
author = {{GxPlex}},
title = {{EMA guideline on computerised systems and electronic data in clinical trials}},
year = {2026},
note = {instrument record, observed 1 August 2026},
howpublished = {\url{https://gxplex.com/instrument/ema-ct-computerised-systems}},
urldate = {2026-08-01},
url = {https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf}
}
APA
GxPlex. (2026). EMA guideline on computerised systems and electronic data in clinical trials [instrument record]. Retrieved 1 August 2026, from https://gxplex.com/instrument/ema-ct-computerised-systems
Observation history
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