Certificate in Clinical Data Management
Duration of COURSE – 3 Months
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.
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.
ICRI 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
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.
Regulatory Affairs Managers: Review & registration of documents, evaluation of technical data, liaison with regulatory authorities.
Clinical Trials Auditors: Conducts audits for regulatory function within the trial department to assure compliance with GLP/GCP in accordance with established FDA regulations and company policies & standard operating procedure.
Clinical Data Manager: Ensures the accuracy & consistency in data prepared for regulatory bodies for reporting purpose.
Others: Auditors, Quality Assurance, Patents & IP Related position
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