Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.6

Document Information

Document information
Reference	EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023
Validity area	EU
Scope(s)	G
Document name	EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials
Version / Revision	2023
Status	Current
Document type	Official guideline
Language(s)	EN
Description	EMA/INS/GCP/112288/2023 Good Clinical Practice Inspectors Working Group (GCP IWG) Guideline on computerised systems and electronic data in clinical trials
Official source	Official link
Restricted access	No
Submitted by	Florian Adragna
Contributors

Reference Details

Scope	G
Document part	4.6
Language	EN
Original entry by	Florian Adragna
Contributors
Tags (EN)
Tags (original language)
Tags (FR)
Comment	Criticality and risk assessment for investigator/institution systems

Text

4.6. Criticality and risks

For systems deployed by the investigator/institution specifically for the purposes of clinical trials, the investigator should ensure that the requirements for computerised systems as described in this guideline are addressed and proportionately implemented. For systems deployed by the investigator/institution, the sponsor should determine during site selection whether such systems (e.g. electronic medical records and other record keeping systems for source data collection and the investigator site file) are fit for purpose.