Handbook for Clinical Trials
We have published a useful reference handbook intended to be a quick reference for all persons involved in planning and conducting clinical research.
The following three documents have been selected for their importance and demand when planning a clinical trial with a particular focus on the investigational medicinal product:
- Declaration of Helsinki
- ICH Harmonised Tripartite Guideline for Good Clinical Practice (ICH GCP)
- EU Guidance on Good Manufacturing Practice: Annex 13 Manufacture of Investigational Medicinal Products