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Article, annex, or section this reference covers.
I
Annex 2
Introduction +
E
EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 Annex 5 A5.2 +
Annex 5
A5.2 +
I
Annex A
A.17 +
Annex A
A.5 +
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A A.6.3-001 +
Annex A
A.6.3 +
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A A.6.3-002 +
Annex A
A.6.3 +
Annex A
A.7 +
E
EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 Annex A A5.3 +
Annex A
A5.3 +
I
Annex A - CIP +
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A - medical device-001 +
Annex A - medical device +
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A - medical device-002 +
Annex A - medical device +
Annex B +
Annex D +
Annex E +
Annex E +
Annex F +
Annex I +
Annex I
6.3 +
E