PG Diploma in
PG Diploma in Clinical Data Management
Duration of COURSE – 6 Months
- What Will you Study
Minimum eligibility criteria for application to the online clinical data management course would be either of the following:
MBBS | BAMS| BDS| BHMS| Physiotherapy and Occupational Therapy Graduates | B.Pharm/M.Pharm & Graduates/ Post Graduates in Sciences/Life sciences/ BioSciences with any of the following subjects-Chemistry, Botany, Zoology, Biochemistry, Microbiology, Genetics and Biotech.
clinical data management is a useful branch in clinical research and needs to be taken seriously. The members responsible in data management are actively involved in each and every step of the research trial. The data managers record the data which is high quality and importance. Another important thing to understand about management of clinical data is that it is not a simple process of data recording and involves many phases.
Clinical Data Management can be classified into various steps such as CRF or case report form designing, database designing, CRF annotation, data validation, data entry and discrepancy management. The technologies for recording and analyzing the data derived are changing and developing at a very rapid pace and it is very essential for the modern day data managers to hone their skills and expertise accordingly. The research units are in requirement for skilled data managers who can save their crucial information in the best manner.
The major goal for clinical data management is to collect the data from clinical trials and keep it clean and also eliminate the missing data so that the collected data can be conveniently used for analyzing purposes. There are some specific software applications that can be utilized for the purpose of collecting and cleaning the data. The software has definitely evolved with time. The tools that are used for collection of clinical data have a specific name too and they are known as clinical data management systems or CDMS. Overall, management of clinical data is a pivotal task and requires proper skill.
It provides participants in the online course in clinical data management with a broad understanding of the basic principles employed within it both domestically and internationally.
What will you study
- Module I – Introduction to Clinical Research
- Module II – Basic Clinical Data Management
- Module III – Clinical Trial Management
- Module IV – Ethical Guidelines in Clinical Research
- Module V – Ethics in Clinical Research
- Module VI – Regulations in Clinical Research
For Doctors: Principal Investigators / Co-investigator / Medical Advisor / Drug Developers / Regulatory Affairs Manager / Clinical Research Physician
For Paramedics, Pharmacists & Life Science Graduates: Medical Writers / Clinical Research Associates / Site coordinators / Clinical Research Manager / Drug Development Associates / Clinical Data Management / Pharmacovigilance Executive / Clinical Trail analyst / Drug Reviewer / Drug Safety Physician & many more.
For Management Professionals: (with Life Science/Health Science background): -Business Development / Clinical Project Management / Clinical Research Management / Regulatory Affairs
Clinical Research Investigators: Conduct BA/BE studies, writing / revising SOP, review of protocols, investigators brochures, ICF & CRFs Protocol, CRF & ICF preparations plans and conduct of BA/BEIEC/IRB affairs-GC.
Study Coordinators: Provides safety & protection while collecting & managing the study data.
Data Manager / Biostatistician: Design, study & predict the seriousness of the disease, seriousness of the disease, evaluate new treatments and effectiveness of medication, participate in research design, data collection, choosing & implementing appropriate methodologies, interpreting the results.
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