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Certificate in Clinical Research and Management |
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CLINICAL RESEARCH CONCEPTS, GUIDELINES AND REGULATIONS |
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1. Introduction to clinical research.
2. Pre-clinical research
3. Drug development process
4. Ethics in clinical research
5. ICH-GCP guidelines
6. Schedule Y/NDA/ANDA
7. FDA
8. Phase I - IV, Post marketing surveillance
CLINICAL RESEARCH OPERATIONS
1. Clinical trial design
2. Protocol design and format
3. Case record form
4. Clinical trial supplies and management
5 Feasibility studies
6 Essential documents and trial master file
7 Archiving and record keeping
8 Informed consent
9 Investigator selection
10 Investigators meetings
11 Roles and responsibilities of players in clinical research
(sponsor, investigator,monitor,stastician,project manager)
12 Site Management
13 Conduct Of A Study
14 Pharmacovigilance
15 Report Writing
16 Publication
17 Data Management
18 Project Management
19 Pharmacoepidemology
20 BA/BE Studies
21 Pharmaeconomics
22 Central Laboratory
23 Pharmacovigilance
24 Outsourcing CR Projects
25 Expanded Access Programs
26 Patient Recruitments
27 Audits and Inspections in CR
28 Fraud and Misconduct in CR
29 Communication Skills Required for Effective Monitoring.
30 Liability and Indemnity in Clinical Research |
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CCDM (Certificate in Clinical Data Management) |
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Course Content: |
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Theory: |
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Clinical Trial Process
Clinical Trial Design
Ethics & Good Clinical Compliance
Project Management
Clinical Data Management
– Data Acquisition
– Data Storage
– Data Validation
– Data Entry
– Data Processing
– Data Load/ Transfer
– End- Game Activities
– Data Archiving
Coding
Introduction to Coding
MedDRA
Who Drug
OC TMS
SOPS
Data Security and Data Privacy
Quality Control/ Quality Audit/ QC Processes
Safety Management & Pharmacovigilance
Statistical Analysis & Reporting
Documentation & Document Management System
Soft Skills
Group Discussions:
Protocol Design
CRF Design
DVS |
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Admission Procedure |
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Eligibility |
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Minimum eligibility criteria for application to the course would be either of the following: |
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Applicants are recommended to have one of the following life Science degrees: Bachelor's, Master’s, or PhD, MBBS/ MD/B.D.S /M.D.S/ B.A.M.S / B.H.M.S /B.P.T/ B.Tech (Biotechnology / Pharmaceutical Science) / B. Pharm /M.Pharm /BVSC / B.Sc. (Nursing) / B.Sc./M.Sc, M.Pharmacy, M.Sc /MA (Statistics) |
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Selection Procedure |
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To maintain high academic standard, the Institute gives due importance to the quality of students enrolled. To ensure this, the selection of individual student will undergo the following procedure:
·Personal interview
Screening and selection of students |
