Written by H. Pieterse and in handy A5 format. The ICH GCP guideline with a selection of relevant other guidances like:
- Declaration of Helsinki
- Guidance on the request to the competent authorities for authorization of a clinical trial
- Guidance on Investigational Medicinal Products
- EU Guideline for Good Manufacturing Practice Annex 13 for IMPs
- Guidance for the preparation of Good Clinical Practice Inspections.
English, 130 pages