Property:DocValidityArea
From GxPlex
Country or region code (e.g. AUT, DEU, EU).
U
USA Expedited Review: Categories of Research that may be Reviewed Through an Expedited Review Procedure 1998 +
USA +
USA FDA - E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1): Guidance for Industry March 2018 +
USA +
USA FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection Jan-2009 +
USA +
USA +
USA FDA Guidance for Industry - Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency Mar-2020 +
USA +
USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 +
USA +
USA FDA Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects Oct-2009 +
USA +
USA FDA INFORMATION SHEET - Recruiting Study Subjects, Guidance for Institutional Review Boards and Clinical Investigators Jan-1998 +
USA +
