Clinical trials / GCP / Pharmacovigilance

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Clinical Trial Resources / Pharmacovigilance Resources

EU2014REGULATION (EU) No 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/ECDownload

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ICH 2016 ICH Harmonised Guideline: Integrated addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2). Step 4 version dated 9 November 2016 Download
MHRA 2016 MHRA GxP Data Integrity Definitions and Guidance for Industry – Draft version for consultation July 2016 Download
EU 2012 COMMISSION IMPLEMENTING REGULATION (EU) No 520/2012 of 19 June 2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC Download
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Global 2015 TMF Reference Model v3.0 Download
EU 2006 Rules Governing Medicinal Products in the European Union Volume 10: Clinical Trials – Notice to applicants. Chapter 5: Recommendation on the content of the trial master file and archiving Download
EU 2010

Reflection paper on expectations for electronic source data and data transcribed to electronic data collection tools in clinical trials

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UK

1998

MRC Guidelines for Good Clinical Practice in Clinical Trials Download
 EU 2001 Directive 2001/20/EC on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use [the GCP Directive] Download
 EU 2001 Directive 2001/83/EC on the Community code relating to medicinal products for human use [the Clinical Trials Directive] Download
 EU 2003 Directive 2003/63/EC amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use. Annex 1 Download
 US 2005 Electronic Clinical Data Capture (EDC): Position Paper. Clinical Trial EDC Task Group, PhRMA Biostatistics and data Management Technical Group Download
 EU 2005 Directive 2005/28/EC laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products Download
UK

2006

Statutory Instrument 2006 No. 1928. The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006

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 JP 2004 Ministerial Ordinance on Standards for Quality Assurance for Drugs, Quasi-drugs, Cosmetics and Medical Devices (Good Quality Practices) Download
 JP 1997 MHW Ordinance on Good Clinical Practice (GCP) Download
ICH 1996 ICH Topic E6 Guidlines for Good Clinical Practice. Note for guidance on good clinical practice (CPMP/ICH/135/95) Download
 Investigational medicinal product:
 EU 2003 Rules Governing Medicinal Products in the European Union Volume 4: Good manufacturing practices. Annex 13: manufacture of investigational medicinal products Download
 EU 2005 Detailed guidance for the request for authorisation of a clinical trial on a medicinal product for human use to the competent authorities, notification of substantial amendments and declaration of the end of the trial Download
 EU 2006 Guideline on the requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials  Download
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