Side effect/safety reporting in clinical trials of medicinal products
In clinical trials of medicinal products safety reporting is strictly regulated by law and in the GCP-guideline.
Both investigator and sponsor have a specific responsibility for this.
The presentation Pharmacovigilance in Clinical Trials can be used in training courses for safety reporting or used to self-study.
In addition to a general review, there are separate parts about investigator’s responsibilities and sponsor’s responsibilities.
Quick reference cards for investigator and sponsor is available for download for use during the study.