One of the reasons for good clinical practice (GCP) is to protect the subjects in a research trial. In all research the subjects’ well-being should be paramount Safety checks, procedures, and reporting are fundamental to any research study involving human subjects. This includes the timely detection and management of, adverse events (AE), serious adverse events (SAE), adverse reactions (AR), and suspected unexpected serious adverse reactions (SUSAR). In addition, excellent record keeping, follow-up, and reporting are essential so that appropriate decisions can be taken relating to study participants as well those which help steer the course of the study, based on emerging safety information.
It is also important to collect safety information even when a treatment is on the market. In fact many marketing authorization procedures require PASS studies be performed (post authorization safety studies) in order to collect additional safety information. PSURs (periodic safety update reports) are required for post marketed drugs and companies have an obligation to collect any safety information for the lifetime of the product.
This course provides a background to safety reporting. There is a refresher on the definitions and reporting requirements of AE, SAE, AR and SUSARs, within a clinical trial. We look at the sources of safety information and discuss the evidence that points to the causality of an event. The change in the regulatory environment is reviewed and the role of conditional approval and PASS and PAES studies is also discussed.
The requirement of a DSUR (development safety update report) and PSUR (periodic safety update report) is covered.
- AE, SAE, AR and SUSAR
- How to determine causality
- Reporting timelines
- Sources of information, preclinical clinical, clinical and post marketing
- Changes in the regulatory environment i.e. conditional approvals
- PASS and PAES
- Regulatory reports DSURs PSURs
- Clinical Research Professionals
- Compliance Departments
- Regulatory Departments
- Drug Safety Departments
- Research and Development
- Any personnel that may be involved in safety reporting when conducting clinical trials or following the marketing authorization of a product