Property:RefUnit
From GxPlex
Unit number this reference belongs to.
I
W
I
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.42 - randomization +
3.3.1 +
E
EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 Annex 5 A5.2 +
3.3.2 +
EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023 3.1.2 - Randomisation +
3.3.2 +
U
USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 IV A. Conduct +
3.3.2 +
I
