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:
- Schematic overview CCMO New procedure 01 March 2012 and text of the External Review Directive 2012;
- Explanatory notes regarding the External Review procedure;
- Template of the Research declaration;
- Revised CCMO Directive on the Assessment of Clinical Trial Agreements;
- Model Informatiebrief 3 november 2008 (Dutch);
- Medical Research in Human Subjects Act valid 11 June 2012 (Dutch).
English, 60 pages
Fourth edition, 2015
ISBN:
