Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.2

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
Module	Module 4 — Unit 4.2.3
Scope	G
Document part	4.2
Language	EN
Original entry by	Florian Adragna
Contributors
Tags	Responsibilities, Systems validation, Sponsor, Investigator responsibilities, Data management plan

Content

4.2. Responsibilities

Roles and responsibilities in clinical trials should be clearly defined. The responsibility for the conduct of clinical trials is assigned via legislation to two parties, which may each have implemented computerised systems for holding/managing data:

• Investigators and their institutions, laboratories and other technical departments or clinics, generate and store the data, construct the record, and may use their own software and hardware (purchased, part of national or institutional health information systems, or locally developed).

• Sponsors that supply, store and/or, manage and operate computerised systems (including software and hardware) and the records generated by them. Sponsors may do this directly, or via service providers, including organisations providing e.g. eCOA, eCRF, or IRT that collect and store data on behalf of sponsors.

Please refer to Annex 1 regarding the transfer/delegation to service providers of tasks related to the use of computerised systems and services.