What is data management clinical trials

cdm professionals should meet appropriate expectations and set standards for data quality and also have a drive to adapt to the rapidly changing technology. cdm is the process of collection, cleaning, and management of subject data in compliance with regulatory standards. these cdm tools ensure the audit trail and help in the management of discrepancies. since the pharmaceutical industry relies on the electronically captured data for the evaluation of medicines, there is a need to follow good practices in cdm and maintain standards in electronic data capture. the sdtmig standard[4] describes the details of model and standard terminologies for the data and serves as a guide to the organization. dmp document is a road map to handle the data under foreseeable circumstances and describes the cdm activities to be followed in the trial. data collection is done using the crf that may exist in the form of a paper or an electronic version.

in case of missing or illegible data, a clarification is obtained from the investigator and the issue is resolved. these discrepancies will be highlighted in the system and data clarification forms (dcfs) can be generated. the cdm tools help in the creation and printing of dcfs. for example, the investigators may use different terms for the same adverse event, but it is important to code all of them to a single standard code and maintain uniformity in the process. in a cdm team, different roles and responsibilities are attributed to the team members. he/she is also responsible for designing of data entry screens in the database and validating the edit checks with dummy data. to meet the expectations, there is a gradual shift from the paper-based to the electronic systems of data management.

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