Advanced Diploma Clinical Research Management - Medfutura - Bangalore

Advanced Diploma Clinical Research Management (ADCRM) online / distance education training program covers all the basic and advanced areas of Clinical Research and Clinical Data Management. Successful completion of the 6 months Diploma helps candidates to apply for jobs in both Clinical Research and Clinical Data Management.
Course Duration:
6 Months
Course Fees:
Rs. 14,000
New Batch:
14th of every month
Course Modules:
Clinical Research:
•Introduction to clinical Research
•Clinical Research process
•Introduction to drug discovery and development
•Bioinformatics and drug development (PK, PD)
•GCP guidelines
•Regulatory authorities involved in clinical research
•Roles and responsibilities of investigator and study team
•Essential documentation in clinical research
•Regulatory submission
•Clinical trial requirement in India
•Regulatory environment in USA, Australia, Europe and India
•Schedule Y
•Adverse drug reactions and its management
•Serious adverse events (SAE)
•Pharmacovigilance
•EudraVigilance
Clinical Data Management:
•Overview Of Clinical Research
•Introduction of Clinical Data Management
•-Data Management Process Flow
-Study Setup Process
-Study Conduct Process
-Study Closeout Process
•Regulations in Clinical Research and Data Management
•21 CFR Part 11
•Introduction to Clinical Database and DMP
•-Database Designing Concepts
-Clinical Data Base Development.
-Specification
•Overview of CRF, CRF Design and CRF Completion
•Data Captures Concepts (EDC, Paper)
•Database Validation and Discrepancies Management
•External Data Transfer and Handling
•Coding in Clinical Data management (MedDRA)
•Quality controls in Clinical Management
•Reports and Standards in clinical Data Management (CDISC)
Certification: Regular Self Assessment and Final Exam
Eligibility:
Any Life Science Degree / Diploma
Call: +91(0)8861218888
MEDFUTURA
41, Indrajit Shaney Layout,
Shampur Main Road,
Bangalore.
Near Ambedkar Medical College)
Karnataka 560045 (INDIA)