Clinical Data Management is involved in all aspects of processing the Clinical data, working with a range of computer applications, database systems to support the entire network in it.

The responsibility of clinical data management goes starting from clinical data tracking from locking it and archiving it.

The module covers the principles and practices required to ensure that the patient data collected as part of a clinical trial are of high quality prior to analysis. The course reviews the stages in the data management project life cycle from project preparation, through CRF review and database creation to data entry, data quality control, and project closeout. Compliance with

regulatory requirements and International Conference on Harmonization (ICH) Good Clinical Practice (GCP) is emphasized. Students will learn how to establish the necessary infrastructure (the computing environment and its controls), and how to obtain the necessary skills and resources required to manage a successful data management project.

This module will cover issues relating to the on-going monitoring of the data in a study in order that sufficient data are available to answer the trial’s question reliably without recruiting more patients than necessary or exposing them to unacceptable risks. The module will, therefore, focus on the ethical context of decisions about whether or not to continue entering

Patients into trials. A number of different statistical approaches will be explored, and the role and conduct of data monitoring committees in this process will be examined.

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