Property:DocName
From GxPlex
Full name of the regulatory document.
E
EudraLex – Volume 10 +
Eudralex - volume 4
GMP Guidelines
Annex 11 +
Eudralex - volume 4
GMP Guidelines
Chapter 4 +
European Bioethics Convention +
EU European Medicines Agency’s Data Protection: Notice For Microsoft (MS) Copilot 365 - EMA pilot phase ; EMA/216030/2025 45838 +
European Medicines Agency’s Data Protection: Notice For Microsoft (MS) Copilot 365 - EMA pilot phase ; EMA/216030/2025 +
U
USA Expedited Review: Categories of Research that may be Reviewed Through an Expedited Review Procedure 1998 +
Expedited Review: Categories of Research that may be Reviewed Through an Expedited Review Procedure +
A
FAQ - COVID-19 Studien +
U
FD&C Act -
Federal Food, Drug, and Cosmetic Act +
USA FDA - E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1): Guidance for Industry March 2018 +
FDA - E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1):
Guidance for Industry +
FDA - HUMAN DRUG CGMP NOTES +
USA FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection Jan-2009 +
FDA Guidance for Clinical
Investigators,
Sponsors, and IRBs
Adverse Event Reporting to IRBs —
Improving Human Subject Protection +
USA FDA Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects Oct-2009 +
FDA Guidance for Industry
Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects +
FDA Guidance for Industry -
Computerized Systems Used in
Clinical Trials +
FDA Guidance for Industry -
Computerized Systems Used in
Clinical Investigations +
USA FDA Guidance for Industry - Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency Mar-2020 +
FDA Guidance for Industry -
Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency +
FDA Guidance for Industry -
Electronic Source Data in Clinical Investigations +
USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 +
FDA Guidance for Industry -
Oversight of Clinical Investigations —
A Risk-Based Approach to Monitoring +
USA FDA INFORMATION SHEET - Recruiting Study Subjects, Guidance for Institutional Review Boards and Clinical Investigators Jan-1998 +
FDA INFORMATION SHEET -
Recruiting Study Subjects,
Guidance for Institutional Review Boards and Clinical Investigators +
FDA Information - Observations and citations +
G
GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL +
