Clinical Data Management

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Clinical Data Management

Clinical Data Management (CDM) is a critical phase in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials. This helps to produce a drastic reduction in time from drug development to marketing. Clinical data management is the process of collecting and managing research data in accordance with regulatory standards to obtain quality information that is complete and error-free; the goal is to gather as much of such data for analysis as possible.Specialized tools (i.e., software applications) are used in CDM to create audit trails that allow discrepancies to be minimized even in large and complex clinical trials. Clinical data management systems (CDMS) are especially vital in trials conducted across medical centers in which an enormous amount of data is produced. Examples include Oracle Clinical, rave, eClinical suite, Clintrial, and Macro.CDMSs can be customized and may be tailor-made in the case of large, multinational pharmaceutical companies looking for tools that address the needs of their specific companies. Open source tools such as TrailDB, open CDMS, OpenClinica, and PhOSCo are freely available and can be just as effective.CDM has a variety of roles and responsibilities of team members and take the form of:

  • Data manager – supervises the CDM process
  • Database programmer or designer – performs the CRF annotation, creates the study database, enables data validation, designs data entry screens and performs edit checks using dummy data
  • Medical coder – codes variations such as adverse events and medical history
  • Clinical data coordinator – designs the CRF, prepares the filling instructions, develops discrepancy protocols
  • Quality control associate – checks the accuracy of data entry and performs data audits
  • Data entry associate – tracks the receipt of CRF pages and enters data into a database

To become a certified clinical data manager, applicants must have one of the following:

  • A bachelor’s degree or higher and at least two years of full-time CDM experience
  • An associate’s degree and three years of full-time CDM experience
  • Four years of full-time CDM experience
  • Part-time work experience that equals or exceeds the afore-mentioned criteria

SKILLS Required: Data reconciliation, UAT in startup phase, Data lock activities, external vendor data reconciliation, SAE reconciliation, ECRF design, CDISC, CDASH, SDTM, GCP,21 CFR part 11 guidelines, Medidata Rave, iMedidata, Inform, Clinbase,Oracle Clinical, Spot fire, HPALM, MedDRA,WHO coding, MS Excel, MS Word, Outlook, PowerPoint, RECIST, TMF ,DMP ,DVS, CRF completion guidelines



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