DIPLOMA IN CLINICAL RESEARCH & CLINICAL DATA MANAGEMENT
| Duration | 5 Months | ||||
| Fees | 60 Thousand | ||||
Eligibility |
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| Classes | 4 days per week | ||||
| Faculty | Industry Professionals & Experts | ||||
| Job Opportunities | Data Coordinator / Data Reviewer / Data Base Designer / Data Management Scientist /e CRF Designer / Data Quality Analyst / Team Leader – DBMS, Clinical Research Associate / Clinical Research Coordinator | ||||
| Job Openings | Clinigene/ Icon clinical / Symphony / Accenture/Quintiles/ TCS / Cognizant etc |
CR & CDM COURSE MODULES
1. Clinical Trial Process
- 1 New Drug Development
- Preclinical Trials
- The 4 phases of Clinical Trials
2. Pharmacology
- Bioequivalence Study ( BE )
- Bioavailability ( BA )
- Pharmacokinetics - ADME
- Pharmacodynamics
3. Regulatory Affairs & Documentation
- Evolution of Drug Regulation.
- Protocol
- Informed Consent Form and Process
- Investigator Brochure
- CRF
- IRB ( IEC )
- Schedule Y
4. Clinical Trial Operations
- Site and Investigator Selection
- Recruitment
- PSUR
- Clinical Trial Study Design
- Adverse Events
- Data Management
5. Biostatistics & SAS in clinical trials
6. ICH – GCP
7. Qulity
- Audit
- Errors - Misconduct and Fraud
- Quality Control
8. Pharmacovigilance
- ADR Definition; Classification; Identification
- ADR Assessment – Causality scales
- Importance of PV National & International Scenario
- Regulatory Aspect of PV
- ADR Reporting /
- MEDRA / Drug Dictionary
9. CDM
- Clinical Data Management
- Data capture methods
- Data Entry
- External Data Loading
- Data Validation
- Query Management
- Data Storage Database lock & archival
- Preclinical Trials
- Quality Systems, SOP’S & Audits
- Regulations & guidelines for CDM
- Safety Data Management
- Statistical Analysis & Reporting
- Biostatistics & SAS in clinical trials
- Data Management Systems & Tools
- Documentation & Document Management System
- Medical coding and medical dictionaries
10. Mock Interview
- Inter Personal Skills
- Group Discussions
- Soft Skills
- Personality Development
11. Seminar & Final Examination
COURSE MODULES
ADVANCED DIPLOMA
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