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List of results

• Document:ICH ICH E3 Guideline 1995  + (ICH ICH E3 Guideline 1995)
• Document:ICH ICH E6 Guideline - Annex 2 R3 Annex 2  + (ICH ICH E6 Guideline - Annex 2 R3 Annex 2)
• Document:ICH ICH E6 Guideline R3 (2025)  + (ICH ICH E6 Guideline R3 (2025))
• Document:ICH ICH E7 Guideline 1993  + (ICH ICH E7 Guideline 1993)
• Document:ICH ICH E8 Guideline R1 (2021)  + (ICH ICH E8 Guideline R1 (2021))
• Document:ICH ICH E9 Guideline 1998  + (ICH ICH E9 Guideline 1998)
• Document:ICH ICH E9 Guideline - Addendum R1 20-Nov-2019  + (ICH ICH E9 Guideline - Addendum R1 20-Nov-2019)
• Document:ICH ICH Guidelines -  + (ICH ICH Guidelines -)
• Document:IMDRF IMDRF – Guidelines -  + (IMDRF IMDRF – Guidelines -)
• Document:INT ISPE - GPP Revision 3 (2015)  + (INT ISPE - GPP Revision 3 (2015))
• Document:INT Nuremberg Code 1947  + (INT Nuremberg Code 1947)
• Document:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020  + (ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020)
• Document:N.A. (STROBE)statement: guidelines for reporting observational studies Apr-2008  + (N.A. (STROBE)statement: guidelines for reporting observational studies Apr-2008)
• Document:N.A. Article from Mora et al. 2023  + (N.A. Article from Mora et al. 2023)
• Document:N.A. Minimum Criteria for ICH E6 (R3) GCP Investigator Site Personnel Training V3.0  + (N.A. Minimum Criteria for ICH E6 (R3) GCP Investigator Site Personnel Training V3.0)
• Document:N.A. SPIRIT 2013 - Chan et al. 2013  + (N.A. SPIRIT 2013 - Chan et al. 2013)
• Document:N.A. Transcelerate GCP mutual recognition programm FAQ 21-May-2025  + (N.A. Transcelerate GCP mutual recognition programm FAQ 21-May-2025)
• Document:SMW Test  + (TEST-SMW-CHECK)
• Document:USA 21 CFR Part 11 09-Apr-2025  + (USA 21 CFR Part 11 09-Apr-2025)
• Document:USA 21 CFR Part 312 09-Apr-2025  + (USA 21 CFR Part 312 09-Apr-2025)
• Document:USA 21 CFR Part 314 09-Apr-2025  + (USA 21 CFR Part 314 09-Apr-2025)
• Document:USA 21 CFR Part 320 09-Apr-2025  + (USA 21 CFR Part 320 09-Apr-2025)
• Document:USA 21 CFR Part 50 09-Apr-2025  + (USA 21 CFR Part 50 09-Apr-2025)
• Document:USA 21 CFR Part 54 09-Apr-2025  + (USA 21 CFR Part 54 09-Apr-2025)
• Document:USA 21 CFR Part 56 09-Apr-2025  + (USA 21 CFR Part 56 09-Apr-2025)

• Document:USA 21 CFR Part 809 06-May-2024  + (USA 21 CFR Part 809 06-May-2024)

• Document:USA 21 CFR Part 812 09-Apr-2025  + (USA 21 CFR Part 812 09-Apr-2025)
• Document:USA 42 CFR Part 11 09-Apr-2025  + (USA 42 CFR Part 11 09-Apr-2025)
• Document:USA 45 CFR Part 160 09-Apr-2025  + (USA 45 CFR Part 160 09-Apr-2025)
• Document:USA 45 CFR Part 46 09-Apr-2025  + (USA 45 CFR Part 46 09-Apr-2025)
• Document:USA Acceptance of Clinical Data to Support Medical Device Applications and Submissions Frequently Asked Questions - Guidance for Industry and Food and Drug Administration Staff 21-Feb-2018  + (USA Acceptance of Clinical Data to Support Medical Device Applications and Submissions Frequently Asked Questions - Guidance for Industry and Food and Drug Administration Staff 21-Feb-2018)
• Document:USA CTCAE - Common Terminology Criteria for Adverse Events v5.0 (2017)  + (USA CTCAE - Common Terminology Criteria for Adverse Events v5.0 (2017))
• Document:USA Expedited Review: Categories of Research that may be Reviewed Through an Expedited Review Procedure 1998  + (USA Expedited Review: Categories of Research that may be Reviewed Through an Expedited Review Procedure 1998)
• Document:USA FD&C Act - Federal Food, Drug, and Cosmetic Act 30-Sep-2023  + (USA FD&C Act - Federal Food, Drug, and Cosmetic Act 30-Sep-2023)
• Document:USA FDA - E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1): Guidance for Industry March 2018  + (USA FDA - E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1): Guidance for Industry March 2018)
• Document:USA FDA - HUMAN DRUG CGMP NOTES Volume 8, Number 3  + (USA FDA - HUMAN DRUG CGMP NOTES Volume 8, Number 3)
• Document:USA FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection Jan-2009  + (USA FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection Jan-2009)
• Document:USA FDA Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects Oct-2009  + (USA FDA Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects Oct-2009)
• Document:USA FDA Guidance for Industry - Computerized Systems Used in Clinical Investigations May-2007  + (USA FDA Guidance for Industry - Computerized Systems Used in Clinical Investigations May-2007)
• Document:USA FDA Guidance for Industry - Computerized Systems Used in Clinical Trials 13-Apr-2015  + (USA FDA Guidance for Industry - Computerized Systems Used in Clinical Trials 13-Apr-2015)
• Document:USA FDA Guidance for Industry - Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency Mar-2020  + (USA FDA Guidance for Industry - Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency Mar-2020)
• Document:USA FDA Guidance for Industry - Electronic Source Data in Clinical Investigations Sep-2013  + (USA FDA Guidance for Industry - Electronic Source Data in Clinical Investigations Sep-2013)
• Document:USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013  + (USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013)
• Document:USA FDA INFORMATION SHEET - Recruiting Study Subjects, Guidance for Institutional Review Boards and Clinical Investigators Jan-1998  + (USA FDA INFORMATION SHEET - Recruiting Study Subjects, Guidance for Institutional Review Boards and Clinical Investigators Jan-1998)
• Document:USA FDA Information - Observations and citations 20-Mar-2024  + (USA FDA Information - Observations and citations 20-Mar-2024)
• Document:USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023  + (USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023)
• Document:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024  + (USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024)
• Document:USA NIH - SCORE Manual N.A.  + (USA NIH - SCORE Manual N.A.)
• Document:USA NIH - SCORE Manual: Appendix Source Documents Requirements Rev 01 16-Aug-2025  + (USA NIH - SCORE Manual: Appendix Source Documents Requirements Rev 01 16-Aug-2025)
• Document:USA NIH - Glossary 27-May-2025  + (USA NIH - Glossary 27-May-2025)
• Document:USA Recognized Consensus Standards N.A.  + (USA Recognized Consensus Standards N.A.)