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GSP

NOTE:

While other GxP are proposed by the regulatory agencies, there is no officially issued guidance on GSP (Good Statistical Practices) and GCDMP (Good Clinical Data Management Practices).

However, the principles of these two good practices have been largely covered in ICH guidances, specifically, E9 (Statistical Principles for Clinical Trials) and E6 (Good Clinical Practice).

  • CPMP/ICH/363/96. ICH E9 Statistical Principles for Clinical Trials. link
  • CPMP/ICH/135/95. E6 (R1) Guideline for good clinical practice. link

GCP applied to Data Management

Research ethics, publication ethics and good practice guidelines from EQUATOR

 

 

PSI Statisticians in the Pharmaceutical Industry. GUIDELINES FOR STANDARD OPERATING PROCEDURES for Good Statistical Practice in Clinical Research. Written by: PSI Professional Standards Working Party download

Proposed best practice for statisticians in the reporting and publication of pharmaceutical industry-sponsored clinical trials equator pubmed

The American Statistical Association. Ethical Guidelines for Statistical Practice. Prepared by the Committee on Professional Ethics link

Guidelines for Statistical Reporting in Articles for Medical Journals link

Bailar JC 3rd, Mosteller F. Guidelines for statistical reporting in articles for medical journals. Amplifications and explanations. Ann Intern Med. 1988 Feb;108(2):266-73. Pubmed

Anne Wiles, Gary Atkinson, Les Huson, Peter Morse, Lesley Struthers. Good Statistical Practice in Clinical Research: Guideline Standard Operating Procedures. PSI Professional Standards Working Party. Therapeutic Innovation & Regulatory Science April 1994 vol. 28 no. 2 615-627. doi: 10.1177/009286159402800237 // Drug Information Journal April 1994 28: 615-627 link

Philip M. North. Ensuring Good Statistical Practice in Clinical Research: Guidelines for Standard Operating Procedures (An Update). Drug Information Journal July 1998 32: 665-682. Therapeutic Innovation & Regulatory Science July 1998 vol. 32 no. 3 665-682. doi: 10.1177/009286159803200308 link

Ulrich Mansmann, Katrin Jensen, Peter Dirschedl. GOOD BIOMETRICAL PRACTICE IN MEDICAL RESEARCH: Guidelines and Recommendations. link

Best practice guide for using statistics in communications link

Murray CJ. Towards good practice for health statistics: lessons from the Millennium Development Goal health indicators. Lancet. 2007 Mar 10;369(9564):862-73. Pubmed

Andreas Zipfel. Guest Editor’s Note: A European Concept for Good Statistical Practices in Global Drug Development. Drug Information Journal, Vol. 29, P. 471, 1995 link

Shein-Chung Chow. Good Statistics Practice in the Drug Development and Regulatory Approval Process

Drug Information Journal October 1997 31: 1157-1166, Therapeutic Innovation & Regulatory Science October 1997 vol. 31 no. 4 1157-1166; doi: 10.1177/009286159703100414 link

 

Pharmacovigilance

EMA Guidelines on good pharmacovigilance practices (GVP), modules I to XVI. link

EMA/95098/2010 (amended) ENCePP Guide on Methodological Standards in Pharmacoepidemiology (Revision 1) link

The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance. link

 Checklist of Methodological Standards for ENCePP Study Protocols. link

 von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. J Clin Epidemiol. 2008 Apr;61(4):344-9. STROBE

FDA. Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment. March 2005. link

 Weinstein MC, O’Brien B, Hornberger J, Jackson J, Johannesson M, McCabe C, Luce BR; ISPOR Task Force on Good Research Practices–Modeling Studies. Source. Principles of good practice for decision analytic modeling in health-care evaluation: report of the ISPOR Task Force on Good Research Practices–Modeling Studies. Value Health. 2003 Jan-Feb;6(1):9-17. PubMed Link

 

Universities

Leicester link
Reading link

 

Pharmacology

Lew M. Good statistical practice in pharmacology. Problem 1. Br J Pharmacol. 2007 Oct;152(3):295-8. Epub 2007 Jul 9. Pubmed
Lew M. Good statistical practice in pharmacology. Problem 2. Br J Pharmacol. 2007 Oct;152(3):299-303. Epub 2007 Jul 9. Pubmed

Lew MJ. On contemporaneous controls, unlikely outcomes, boxes and replacing the ‘Student’: good statistical practice in pharmacology, problem 3. Br J Pharmacol. 2008 Nov;155(6):797-803. doi: 10.1038/bjp.2008.350. Epub 2008 Sep 22. Pubmed

 

 

 

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