Research that takes place in a hospital or clinical setting and is focused on treating specific human and animal diseases and other ailments. Clinical research builds upon the knowledge learned through applied and basic research. Clinical research is conducted on human beings and takes shape in treatments and drugs that directly improve human healthcare
A clinical data management system or CDMS is used in clinical research to manage the data of a clinical trial. The clinical trial data gathered at the investigator site in the case report form are stored in the CDMS. To reduce the possibility of errors due to human entry, the systems employ different means to verify the entry. The most popular method being double data entry.
Once the data has been screened for typographical errors, the data can be validated to check for logical errors. An example is a check of the subject's age to ensure that they are within the inclusion criteria for the study. These errors are raised for review to determine if there is an error in the data or clarification from the investigator is required.
Another function that the CDMS can perform is the coding of data. Currently, the coding is generally centered around two areas; adverse event terms and medication names. With the variance on the number of references that can be made for adverse event Terms or medication names, standard dictionaries of these terms can be loaded into the CDMS. The data items containing the adverse event terms or medication names can be linked to one of these dictionaries. The system can check the data in the CDMS and compare it to the dictionaries. Items that do not match can be flagged for further checking. Some systems allow for the storage of synonyms to allow the system to match common abbreviations and map them to the correct term. As an example, ASA could be mapped to Aspirin, a common notation. Popular adverse event dictionaries are MedDRA and WHOART and popular Medication dictionaries are COSTART and WHO-DRUG.
- Clinical Research life cycle.
- Clinical Operation
- Regulatory Affairs
- Quality Assurance
- FDA, GCP, ICH
- Clinical Data Management life cycle
- 21 CFR PART 11 Regulations
- Software’s for clinical data management.
Bachelor's, Masters, or a Ph.D. in a Science or Allied Health Field; OR Healthcare Professional Medical Technologist, B.sc, M.sc life sciences.Pharmacy, Biotech, Computer.
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