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Version or revision date.
U
Aug-2023 +
W
Forty-fifth
report +
U
USA FDA INFORMATION SHEET - Recruiting Study Subjects, Guidance for Institutional Review Boards and Clinical Investigators Jan-1998 +
Jan-1998 +
USA FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection Jan-2009 +
Jan-2009 +
E
U
USA FDA Guidance for Industry - Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency Mar-2020 +
Mar-2020 +
USA FDA - E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1): Guidance for Industry March 2018 +
March 2018 +
G
May 2021 +
U
May-2007 +
G
May-2015 +
U
USA FDA Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects Oct-2009 +
Oct-2009 +
I
R1 (2017) +
R1 (2021) +
R3 (2025) +
R3 Annex 2 +
U
Rev 01
16-Aug-2025 +
E
Rev. 3 (2017) +