Clinical Data Management : A multidisciplinary endeavor tool

Clinical data management (CDM) encompasses the entry, verification, validation and quality control of data gathered during the conduct of clinical trial. This helps to produce a drastic reduction in time from drug development to marketing. CDM is a critical phase in clinical research which leads to generation of absolutely accurate and statistically sound data from clinical trials.

Two such standards created by the clinical data Interchange Standards Consortium (CDISC) are particularly vital to Clinical data management: the Study Data Tabulation Model Implementation Guide for Human Clinical Trials (SDTMIG) and the Clinical Data Acquisition Standards Harmonization (CDASH). The former is currently mandated for use by the U.S. food and drug Administration (FDA). The latter created a standard format for collecting data across studies so that data submissions can be more easily traced and reviewed. Members of clinical data management team (CDM) are actively involved in all stages of clinical trial right from inception to completion.

Case report form (CRF) is a specialized document for collection of patient’s data in a clinical trial. CRF is a paper or electronic questionnaire. Clinical Data Management System is widely used to manage the data that is collected as part of a formal clinical trial programme. Data obtained from the investigator site in the CRF is stored in the CDMS. CDMS also performs coding of data and employs various means to verify the data to reduce possibility of error due to human entry. Once the data are uploaded by site then data validation is done by data validation team if there is any discrepancy then alert is send to the site to resolve it.

Similarly, CDMS is a tool for capturing and delivering accurate ongoing patient care data. Collection of ongoing assessment data includes past health of patient as well as current/present problems of patient, its treatment plan and therapeutics. All hospital or clinic based data can also be captured and regular clinical practice analytics can be obtained.

Medical coding or Medical classification is the transformation of narrative descriptions of diseases, injuries and healthcare procedures into numeric or alphanumeric designations (that is, code numbers). The diagnoses and procedures are usually taken from a variety of sources within the health care records, such as the transcription of the physician’s notes, laboratory results, radiologic results. The dictionaries used for adverse events: MedDRA (Medical Dictionary for Regulatory Activities) and for medications: WHO-DD (World Health Organization Drug Dictionary).

Validation of data is the process of checking database. Data should be clean, accurate and in a standard format for overall study. Quality should be maintained for overall study by performing quality checks at intervals for all data points prior to database lock. Database lock for a study is done to ensure no manipulation of study data during the final analysis. Database lock for a study is done once all data management activities are completed. Organization of data ensures collected material is accepted in the scientific community.

The ultimate goal of CDM is to assure valid and correct data support conclusions from research. Achieving this goal protects public health and confidence in marketed therapeutics. WorkSure has developed its own 21 CFR compliant CDMS which can be used both for Clinical trials and Hospital/clinics patient data collection and management. Our simple and easy to use CDMS even help complex data collection, with an added advantage of competitive cost.