ADVERSE EVENTS AND SAFETY MONITORING IN CLINICAL TRIAL

ADVERSE EVENTS AND SAFETY MONITORING

    The adverse events are monitored during clinical trials for the protection of the subjects enrolled in the trial as well as for protection of the patients and proper use of the drug, once it is marketed. Monitoring safety during a clinical trial is one of the most important tasks a Clinical research associate performs. At the same time, safety reporting in one of the most difficult things for the study site to do correctly. There are often misunderstandings about what is necessary for reporting on safety issues in trials, stemming at least in part because of the differences in clinical studies as compared to clinical practice. Also, although the regulations charge the investigator with protecting the rights, safety and well-being of subjects in trials. Here the regulations are demonstrated below.

Adverse Events

Safety Reports- The investigator must report to the sponsor about any adverse effects which may be appeared after the administration of new drug molecule. If the adverse effects is found in any moment, the sponsor must be acknowledged it by the investigator immediately.

Adverse Effects- Adverse effect is any undesirable or unintended consequence of new drug administration.

Adverse Events- Adverse event is used to mean any untoward medical occurrence that may present during treatment with new drug molecule in clinical trial but it does not have relationship with this treatment.

Adverse Drug Reaction- Adverse drug reaction is defined as any noxious change which is suspected to be present in the participating subjects due to administration of new drug, requires immediate treatment by decrease in dose. It helps to indicate the cautions for the future use.

    In clinical trial study the sponsor must be required to inform to FDA(Food & Drug Administration) about any serious, unexpected adverse events related to investigational drug withing fifteen day of the time period.