Clinical data management system

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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 possiblity 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 a 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 corrent 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.

At the end of the clinical trial the dataset in the CDMS is analyzed and sent to the regulatory authorities for approval.

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[edit] References

Stuart Summerhayes, CDM Regulations Procedures Manual, Blackwell Publishing, ISBN 1-4051-0740-5
Tai BC, Seldrup J., A review of software for data management, design and analysis of clinical trials, Ann Acad Med Singapore. 2000 Sep;29(5):576-81.
Greenes RA, Pappalardo AN, Marble CW, Barnett GO., Design and implementation of a clinical data management system, Comput Biomed Res. 1969 Oct;2(5):469-85.