What does Clinical Safety comprise of?
Students who prefer to select clinical safety are mostly in for an interesting role as this position concerns the medical aspects of any clinical trial or study. Clinical research courses prepare one for the clinical safety profession. Most students may ask the question ‘What does clinical safety comprise of? So, clinical safety consists of majority of the aspects of a clinical trial including the protocol, patient informed consent, and patient safety outcomes in the final study report and Instructions for Use(IFU) document. These mostly are covered extensively in clinical research courses.
Roles and Responsibilities of Clinical Safety
1. Have an understanding of regulatory requirements of patient safety
In the industry, the clinical safety team has an in-depth understanding of regulatory requirements concerning the safety of any clinical trial. Clinical research courses tell one what to do if there is an adverse event. Regulatory agencies look into the safety of the clinical trial procedure and investigational device or drug. So, if patients experience an adverse event, clinical sites, sponsors and CROs are expected to meet strict adverse event reporting requirements. This is a major concern of the industry hence it is given importance in clinical research courses.
2. Their responsibilities concern adverse events management
These professionals also known as a safety monitor oversee the safety aspects of a clinical trial such as adverse events, clinical trial procedure risks, and device/ drug risks. PG Diploma in Clinical Research give equal importance to these positions as they review adverse events experienced by the participants. Once an adverse event takes place, the safety team evaluates and communicates the adverse event information with stake holders such as clinical trial sites, patients, and regulatory agencies. So student scan be assured of quality training on safety from clinical research courses
3. Be in charge Clinical Events Committee (CEC)and Data Monitoring Committee (DMC)
Once the adverse events are reported to the trial sponsor or CRO, the safety team reviews reported adverse events and collects relevant medical records. Then, these adverse events and the corresponding relevant medical records are the Clinical Events Committee (CEC). The safety team supervises the selection and operation of a CEC. So, these events are covered in clinical research courses.