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