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Clinical Safety Data Management
What is clinical safety data management?
It is the process of capturing, management and reporting of safety data. It involves data collection, qualitative check on collected data and finally, the creation of a database that is the organized and validated information derived from the data collected. A series of procedures and a band of industry experts are needed to carry out the necessary procedures.
History:
Clinical safety is very important to ensure the safety of drugs pre-marketing and post-marketing. It should be standardized and elaborate enough to promise complete safety. The elaborative nature of drug safety data management has been evolving to improve. It began as a mere data entry process, an information hub which needed organization and cleaning. The clinical data reports we have today is a clean data in a useable format fit to be used and understood with ease. It is a very visible and strong organization now.
Importance of Clinical safety data management:
It is done to ensure quality of data being transferred from subjects to the database system. The data thus gathered and produced is accurate, valid clinical data. It aids the overall drug development organization by monitoring and regulating clinical standards. It also ensures that relationships with other organizations continue to evolve.
When and why should it be done?
It is done in the event of adverse experiences with drugs, adverse drug reactions, unexpected adverse drug reactions and serious adverse drug reactions. Under such circumstances, affected people are taken as subjects, clinical trials are made. The findings are recorded, investigated and documented so that any such instances are avoided in future.
Process involved drug safety data management:
Data collection and management, financial management, site management, trial management, pharmacovigilance, clinical program management and regulatory submission are the several aspects involved in the data management. The order may change. But they are vital ingredients that go into managing a clinical data.
The Process:
This is how a typical data management in the clinical sector works:
- A subject is chosen and is thoroughly investigated by the investigator.
- A sample of the investigation is sent to the laboratory for clinical report and also to the monitor ho monitors the investigation report of the subject.
- The lab results are sent to the data manager, who along with his team manages the laboratory results obtained.
- A statistician is usually involved to statistically analyze the data.
- This data is then passed on to a clinician who converts the available information into clinical data.
- The resultant data is sent to a regulatory authority through NDA who finally checks for quality and approved the data.
Terminology:
Adverse Event (or Adverse Experience) AE
Any untoward medical occurrence in a patient or clinical investigation subjectadministered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Adverse Drug Reaction (ADR)
All noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions.
Unexpected Adverse Drug Reaction
An adverse reaction, the nature or severity of which is not consistent with the applicable product information.
About the Author
I am a pharmaceutical professional involved in clinical safety drug management in a private drug safety pharmacovigilance firm. I like to share my experience and knowledge about pharmacy concepts through my articles.
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