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Clinical data management is a profession with increasing importance within pharmaceutical research and development. The diverse lineage of clinical data management coupled with a wide range of responsibilities makes a clear, clean definition of ‘clinical data management’ difficult at best. Clinical data management is a pertinent and important part of a clinical trial. Data is defined as any information or fact related to clinical trial. Management of data capture and data flow process is an important part of clinical data management. A clinical data management expert is an integral, respected and highly valued member of any clinical development team. Before beginning the trial, the thought is given to data management, as well as data privacy, data storage, record keeping, data security, destroying the data and sharing and reporting the data.
We feel that the next decade will see major changes with the advantage of electronic data capture. The clinical and data jobs/disciplines as we know them today will become one as companies use more and more sophisticated hardware and software to streamline and eliminate duplication from the clinical trial process. Gone will be the days of the Investigator giving the CRF to CRA, CRA giving the CRF to DM, DM giving the CRF to DE. DE enters it, gives CRF back to DM and so on.
This program is developed with the primary objectives of Introduction to the Clinical Data Management process, understanding of tools and management of clinical data.
Module 1: Introduction to Clinical Research.
Module 2: Introduction to Data Management
Module 3: CRF Design Considerations
Module 4: Data Entry, Remote Data Entry
Module 5: Identifying and Managing Discrepancies
Module 6: Data Management Plan
Module 7: Electronic Data Capture
Module 8: Tracking CRF Data
Module 9: Managing Lab Data
Module 10: Collecting Adverse Event Data
Module 11: Creating Reports and Transferring Data
Module 12: Case Studies
Eligibility
Any Indian or overseas applicants must fulfill following criteria for enrolling into the six months Pharmacovigilance program. The applicant must be a graduate in any discipline.
Medbiosys Benefits
• Student centered approach in all the activities of Medbiosys.
• Cultivation of pro-active work culture is in the process.
• Good industrial and research institutional linkages; these are effectively used for developing courses, and for the purpose of placement of students.
• Medbiosys will also embarked upon international linkage by signing MoU with some foreign universities.
Online availability of course content and lectures with live interactions.
Course Duration
The course will be completed over a period of 1 semester which will include the tenure applicable for examinations as well as case studies completion. Evening and Weekend course with lectures held depending on the slot selected.