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Data Management in Clinical Trials

PG Diploma in Clinical Research

Data Management in Clinical Trials

Skilled and trained professionals of data management help reduce the time-consuming processes from drug development to marketing stage.

Data management 

Data Management is critical in clinical trial to lead and generate reliable, high-quality and statistically sound data by drastically reducing the number of stages involved in drug development process and marketing. Case report form (CRF) annotation and designing; data entry, extraction and validation; database designing and locking; discrepancy management and medical coding are evaluated at regular intervals for quality checks during clinical trial. Data management includes the entire spectrum of tasks of data collection, entry, analysis and reporting. The consideration of data management is important before starting the trial to include privacy, storage, sharing, record keeping and protection, destruction and reporting of data. 

Application of strong quality assurance and cost-effective measures, therapeutic and regulatory expertise in basic data management functions help adjust to changes, strive to avoid timeline modifications and improve clinical trials. The data collected accounts for efficient clinical trial through right solutions and data management systems that improve efficiency, focus on protocol requirements with technology industry substantiated by solid records in the field. Automated systems are employed to facilitate the central theme of clinical trial data management conducted according to good clinical practices in order to carry out treatment and assessment of participants as per protocol study along with assuring patient safety and integrity of the research. Faster drug development process through quality systems can ensure and benefit generation of high-quality data for accurate drug evaluation.

Education and training

Specific skills required in managing clinical trials include data management plans, development of electronic case report forms, data review and reconciliation. Distance education based module with e-learning approach is designed to complete in a shorter time period and help employed professionals working full-time. Training provides clear understanding and theoretical knowledge of various essential elements of clinical data management; necessary regulatory guidelines; workflow of data management plan; different activities involving data designing, entry and collection; report creation; other roles and responsibilities. Data management knowledge and validation of data in training programmes accomplish professional and organizational benefit to develop well trained and updated experts. Such programs provide excellent professional development opportunities with improved quality and increased efficiency.

Advanced Post Graduate Diploma in Clinical Research & Data Management available at James Lind Institute is designed to provide a complete overview of monitoring clinical research, developing clinical trial processes and managing clinical data. The clinical data management program is developed with extensive consultation with the requirement of the industry and highly recommended for professionals working or planning to work with health related database. The program has been designed to stimulate enjoyable experience, develop skilled and efficient professional, increase chances of employment in areas of clinical research and clinical data management. The curriculum of Advanced Post Graduate Diploma in Clinical Research & Data Management course is fully reviewed and endorsed by the members of the industry which impart skills to empower the professionals in climbing the clinical research data management hierarchy. This course ensures professional career and better job opportunities in the clinical research industry for trial managers, case report designer, clinical data quality assurance or quality control associates in pharmaceutical or biotechnology companies, contract research organisations (CROs) and other sectors.

Online Course at JLI

James Lind Institute (JLI) provides an online program – Advanced Post Graduate Diploma in Clinical Research & Data Management to train professionals in the management of clinical trial data. 

For more information please visit: www.jli.edu.in

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