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GUIDELINE FOR GOOD CLINICAL PRACTICE +
GUIDELINE FOR GOOD CLINICAL PRACTICE E6(R3) Annex 2 +
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GUIDELINES ON MEDICAL DEVICES CLINICAL INVESTIGATIONS:
SERIOUS ADVERSE EVENT REPORTING UNDER DIRECTIVES 90/385/EEC AND 93/42/EEC. +
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DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 +
Gemeinsame Empfehlungen des Bundesinstituts für Arzneimittel und Medizinprodukte und des Paul-Ehrlich-Instituts zur Anzeige von Anwendungsbeobachtungen nach § 67 Absatz 6 Arzneimittelgesetz und zur Anzeige von nichtinterventionellen Unbedenklichkeitsstudien nach § 63f Arzneimittelgesetz +
Gesetz zum Schutz vor der schädlichen Wirkung ionisierender Strahlung (Strahlenschutzgesetz – StrlSchG) +
Gesetz zur Durchführung unionsrechtlicher Vorschriften betreffend Medizinprodukte (Medizinprodukterecht-Durchführungsgesetz – MPDG) +
Gesetz über den Verkehr mit Arzneimitteln (Arzneimittelgesetz – AMG) +
Gesetz über den Verkehr mit Tierarzneimitteln und zur Durchführung unionsrechtlicher Vorschriften betreffend Tierarzneimittel1 (Tierarzneimittelgesetz - TAMG) +
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GBR Guidance Access to Electronic Health Records by Sponsor representatives in clinical trials 44447 +
Guidance
Access to Electronic Health Records by Sponsor representatives in clinical trials
The following guidance has been jointly developed by the Heath Research Authority (HRA) and MHRA, in consultation with the Information Commissioners Office (ICO), on behalf of the UK. +
Guidance
Good clinical practice for clinical trials
How to show the MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection. +
Guidance
Managing clinical trials during Coronavirus (COVID-19)
How investigators and sponsors should manage clinical trials during COVID-19 +
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USA FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection Jan-2009 +
Guidance for Clinical Investigators, Sponsors, and IRBs
Adverse Event Reporting to IRBs — Improving Human Subject Protection +
Guidance for Industry - COMPUTERIZED SYSTEMS USED IN CLINICAL TRIALS +
Guidance for Industry Computerized Systems Used in Clinical Investigations +
Guidance for Industry Electronic Source Data in Clinical Investigations +
USA FDA Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects Oct-2009 +
Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects +
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Guidance on legislation
Clinical investigations of medical devices – compiling a submission to MHRA +
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Guide on Methodological Standards in Pharmacoepidemiology
European Network of Centres for Pharmacoepidemiology & Pharmacovigilance (ENCePP) +
Guideline on good pharmacovigilance practices (GVP)
Module XVI – Risk minimisation measures (Rev 3)
(Including NIS) +
Guideline on good pharmacovigilance practices (GVP)
Module VIII – Post-authorisation safety studies (Rev 3) +
