instruction manual 2015

Clinical Research with medicinal products in the Netherlands – Instruction Manual including errata

€ 20,00

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Product Description

The NEW 2015 UPDATE of the instruction manual has been published with the objective to upgrade the manual to a comprehensive compendium with all relevant rules and regulations for the conduct of clinical research in humans in the Netherlands, . In the appendix of the manual the following relevant documents have been included:

  1. Schematic overview CCMO New procedure 01 March 2012 and text of the External Review Directive 2012;
  2. Explanatory notes regarding the External Review procedure;
  3. Template of the Research declaration;
  4. Revised CCMO Directive on the Assessment of Clinical Trial Agreements;
  5. Model Informatiebrief 3 november 2008 (Dutch);
  6. Medical Research in Human Subjects Act valid 11 June 2012 (Dutch).

English, 60 pages
Fourth edition, 2015
ISBN:

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