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PCCRCDM (Professional Certificate in Clinical Research and Clinical Data Management) |
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PCCRHV (Professional Certificate in Clinical Research and Pharmacovigilance) |
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CCCR (Certificate Course in Clinical Research) |
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PCCRCDM (Professional Certificate in Clinical Research and Clinical Data Management) |
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Course Content: |
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Clinical Trial Process
Clinical Trial Design
Ethics & Good Clinical Practice
Clinical Data Management
CRF Design
Data Entry
Data Collection
Data Load
Data Storage
Data Validation
Query Management
Data Archiving
Quality Systems, Sops & Audits
Regulatory Affairs & Compliance
Safety Management and Pharmacovigilance
Statistical Analysis & Reporting
Data Management Systems & Tools
CDMS
AERS
EDC
Analytical Tools
Documentation & Document Management System
Medical coding and medical dictionaries
Project Management
Security systems
Practical:
Clinical Data Management System
Study Set-Up
Database Creation
CRF Creation
Data Entry
Data Validations
Query Management
Database lock
Statistical Software
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PCCRHV (Professional Certificate in Clinical Research and Pharmacovigilance) |
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Course Details:
Designing of Clinical Trials
Pharmacokinetics & Drug Interactions
Overview Definitions and Concepts
Managements of Clinical Trails
Audits and Inspection
Clinical Research Process Outsourcing
Basic in Pharmacology I Pharmacy
Drug Discovery & Development
Introduction to Pharmacovigilance:
Definition, relevance, application and scope.
Pharmacovigilance Planning
WHO, CIOMS, ICH
Safety Data Management
Safety information, Clinical trial information
Safety Data collection and Systems
Post- Marketing Surveillance
Clinical vs. post marketing drug safety
Post- Marketing safety in USA, Europe & Japan
Regulatory Submission
Safety reporting requirements
Individual case safety reports
Periodic safety update reports
Query management
Electronic safety reporting
Regulatory inspections
Signal Detection
Introduction to Signal
Signal detection process
Risk Management
Risk Maps
Safety assessment
QA in Pharmacovigilance
Types of SOPs
SOP maintenance & training
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CCCR (Certificate Course in Clinical Research) |
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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:
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
Eligibility
Minimum eligibility criteria for application to the course would be either of the following:
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)
Selection Procedure
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 |
