Clinical Data Management
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A clinical data
management system or CDMS is a tool 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
The CDMS can be broadly divided into Paper based and electronic data capturing system.
Paper Based Systems
Case report forms are manually filled at site and mailed to the company for which trial is being performed. The data on forms is transferred to the CDMS tool through data entry.The most popular method being double data entry where two different data entry operators enter the data in the system independently and both the entries are compared by the system. In case the entry of a value conflicts, system alerts and a verification can be done manually. Another method is Single Data Entry.
The Data in CDMS is then transferred for the data validation. Also, in these systems during validation the data clarification from sites are done through paper forms which are printed with the issue description and sent to the investigator site and site responds by answering on forms and mailing it back.
Electronic Data Capturing System
In such CDMS the investigators directly uploads the data on CDMS and the data can then be viewed by the data validation staff. Once the data is uploaded by site, data validation team can send the electronic alerts to sites if there is any issue.
Such systems nullifies the paper usage in Clinical trials validation of data.
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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 Dictionary.
At the end of the clinical trial the dataset in the CDMS is extracted and provided to statisticians for further analysis. The analysed data is compiled into clinical study report and sent to the regulatory authorities for approval.
Institutions offering short term Clinical Data Management.
Institute of Clinical Research, India offers Postgraduate Diploma in Clinical Data Management. The eligibility criterion is graduation. Graduates with computer background are preferred. The admission is based on performance at Interview. For details, log on to www.icriindia.com
Bioinformatics Centre, University of Pune offers Postgraduate Certificate Course in Clinical Research and Clinical Data Management. The eligibility criterion is MBBS/ BDS/ BAMS/ BHMS/ BE/ B. Tech/ B. Pharmacy/ BVSC/ B.Sc. (Nursing)/ MCA/ MBA/ M.Sc/ M.Pharm/ MA (Maths or Statistics)/ B.Sc (with minimum one year relevant industry/ academic research work experience). For details, log on to www.unipune.ernet.in
Goa University, Faculty of Life Science, Goa offers Postgraduate Diploma in Clinical Research and Clinical Data Management. The eligibility criterion is MBBS/ BDS/ BAMS/ BHMS/ BE/ B. Tech/ B. Pharmacy/ BVSc/ B.Sc. (Nursing)/ MCA/ MBA/ MSc / M.Pharm/ MA (Maths or Statistics)/ B.Sc. Candidates with experience in a medical institution, pharmaceutical company or Clinical Research unit or postgraduates are preferred. For details, log on to www.unigoa.ac.in