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Guidelines for Good Pharmacoepidemiology Practices (GPP)
International Society for Pharmacoepidemiology (ISPE) +
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HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) GUIDANCE FOR IMPLEMENTATION +
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HRA - Ending your project +
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ICH guideline E8 (R1) on general considerations for clinical studies +
IMDRF: International Medical Device Regulators Forum
IMDRF documents - https://www.imdrf.org/documents/library
- Technical documents
Global Harmonization Task Force (GHTF) - https://www.imdrf.org/documents/ghtf-final-documents
GHTF Study Group 1 - Pre-market Evaluation
GHTF Study Group 2 - Post-market Surveillance/Vigilance
GHTF Study Group 3 - Quality Systems
GHTF Study Group 4 - Auditing
GHTF Study Group 5 - Clinical Safety/Performance +
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USA FDA INFORMATION SHEET - Recruiting Study Subjects, Guidance for Institutional Review Boards and Clinical Investigators Jan-1998 +
INFORMATION SHEET
Recruiting Study Subjects
Guidance for Institutional Review Boards and Clinical Investigators +
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EU INS/GCP/46309/2012 - Classification and analysis of the GCP inspection findings of GCP inspections conducted at the request of the CHMP 2012 +
INS/GCP/46309/2012
Compliance and Inspections
Classification and analysis of the GCP inspection findings of GCP inspections conducted at the request of the CHMP
(Inspection reports to EMA 2000-2012) +
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IRAS: Integrated Research Application System ;
provides a single gateway for researchers to apply to the new NIHR Coordinated System for gaining NHS Permissions (NIHR CSP). +
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ISO 14155:2020
Clinical investigation of medical devices for human subjects — Good clinical practice +
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Informed Consent
Guidance for IRBs, Clinical Investigators, and Sponsors +
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Instruction interministérielle DHOS/E1/DAF/DPACI no 2007-322 et (no DAF/DPACI/RES/no 2007-014) du 14 août 2007 relative à la conservation du dossier médical
NOR : SJSH0730928J +
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Internal notes:
HUMAN DRUG CGMP NOTES
(Volume 8, Number 3)
September, 2000
(A Memo for FDA Personnel on Current Good Manufacturing Practice For Human Use Pharmaceuticals)
Issued By: The Division of Manufacturing and Product Quality, HFD-320
Office of Compliance
Center for Drug Evaluation and Research
Project Manager: C. Russ Rutledge, HFD-325 +
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International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
- Q: Quality guidelines (conduct of
stability studies, defining relevant thresholds for impurities testing and a more flexible approach to pharmaceutical quality based on Good Manufacturing Practice (GMP) risk management, …)
- S: Safety Guidelines (uncover potential risks like carcinogenicity, genotoxicity and reprotoxicity, non-clinical testing strategy for assessing the QT interval prolongation liability, …)
- E: Efficacy Guidelines (design, conduct, safety and reporting of clinical trials)
- M: Multidisciplinary Guidelines (cross-cutting topics which do not fit uniquely into one of the Quality, Safety and Efficacy categories. It includes the ICH medical terminology [MedDRA], the Common Technical Document [CTD] and the development of Electronic Standards for the Transfer of Regulatory Information [ESTRI]) +
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International Ethical Guidelines for Health-related Research Involving Humans
Prepared by the Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization (WHO) +
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International Statistical Classification of Diseases and Related Health Problems (ICD) +
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Investigations cliniques de dispositids médicaux relevant du r`glement européen n°2017/745
Partie II
Demande de mise en oeuvre
Modalités pratiques +
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Leitlinien und Empfehlungen zur Sicherung von Guter Epidemiologischer Praxis (GEP) - Deutsche Gesellschaft für Epidemiologie (DGEpi) +
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Loi constitutionnelle du 3 juin 1958 +
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MDCG 2020-10/1 Rev 1
Safety reporting in clinical investigations of medical devices under the Regulation (EU) 2017/745 +
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Making changes to a research study to manage the impact of COVID-19 +
