IICR’s PGD-CDM program is a complete package of theory and practical training.

Program Details:

Course: Advanced PG Diploma in Clinical Data Management with Biostats, SAS & ORACLE

Course Objectives:

1.The objective of this program is to provide complete understanding of the clinical research basics, Clinical Data Management and to provide practical knowledge of SAS & ORACLE to the students, which would enable them to work in the industry with minimal training.

2. In the first phase we would provide a comprehensive knowledge of Basic Principals of Clinical Pharmacology, Preclinical Studies & Drug Screening, Systemic Pharmacology, Drug Regulations and Schedule Y, Global Drug Regulations& Guidelines, Designing of Clinical Trials and Biostatics and drug safety monitoring, Clinical Data Management, Project Management & Clinical Trial Documents & SOPs.

3. In the second phase extensive training for 3 months in CDM industry with SAS & ORACLE training.

Career Objectives:

·To provide a comprehensive introduction to the clinical research process.

·Learn the skills, knowledge and competencies of a candidate for the Clinical Research jobs.

· Become more familiar with roles/jobs as part of the study team.

·To understand the basic concepts, importance of every subject.

Methodology: 2 months Regular Classroom studies, followed by 3 months of practical training into the CDM Industry. Regular Guest Lectures by Eminent Key Opinion Leaders of the Industry.

Duration : 5 months

Eligibility : MD, MS, MBBS, BDS, BHMS, BAMS, BUMS, BPT, B.Pharma, Graduate/Post Graduate Degree in Life Sciences, Pharmacology, Pharmacy, Medical Laboratory, Biochemistry, Microbiology, Bioinformatics,Genetics, Bio stats, Biotechnology and all Professionals working with Pharmaceutical companies, CROs and hospitals.

Seat : Limited

Certificate: PGD Certificate would be awarded upon successful completion of the program. In addition, 3 months training certificate from the Company where the student will complete the practical training.

Course Modules:

CLINICAL RESEARCH – THEORY

  1. Clinical Research Past, Present & Future
  2. Clinical Research Introduction & Terminology
  3. Pre-clinical Studies & Drug Screening
  4. Regulatory Affairs
  5. Clinical Phases & Drug Development
  6. Ethics in Clinical Research
  7. Global Drug Regulation & Guidelines
  8. Designing of clinical Trials
  9. Role of CRO, Site Management & Monitoring in Clinical Research
  10. Project Management & Clinical Trials Documents
  11. Clinical Data management & Biostatistics

CLINICAL DATA MANAGEMENT/ORACLE- CLINICAL – PRACTICAL

1. Protocols and CRF Design
2. Data management Plan
3. Database Design
a) Study setup b) CRF Design
4. Data Capture Methods and Data Entry
5. External Data Loading and Data Validation
6. Validation procedures
7. Derivation Procedures
8. Data Entry
a) First pass entry b) Second pass entry c) Reconciliation
9. Batch Validation
10. EDC (Electronic Data Capture)
11. Discrepancy Management
12. Loading of Lab data electronically
13. Database Locking and Freezing
14. Data Extraction
SAS – PRACTICAL

1. Basics of statistics for Clinical
2. Reporting Clinical Trial analysis
3. Introduction to SAS in CDM
4. Base/SAS
5. SAS/STAT
6. SAS/GRAPH
7. SAS Macros
8. SAS/SQL
9. Statistical significance
10. Custom Derived SAS data sets
11. SAS-Programming for NDAs (New Drug Applications)
12. Data Cleaning

 

* “Fees (Registration & program fees)  once paid will not be refundable”