Post Graduate Diploma in Clinical Research (Distance Learning)
by Apheta Institute of Clinical ResearchNew Delhi, Allahabad |
| Eligibility: (Pre-requisites) | A postgraduate or graduate in Bioscience/Life Sciences (with any of the following subjects: Botany, Zoology, Biochemistry, Microbiology, Genetics, Biotech). |
| Medium of instruction: | English |
Syllabus for PG Diploma in Clinical Research
Module 1: Introduction to clinical research
Module 2: Pharmacology and drug development
Module 3: Ethics and Guidelines in Clinical Research
Module 4: Regulation in Clinical Research
Module 5: Clinical Trial Management
Module 6: Clinical Data Management & Biostatistics
Module 1: Introduction to Clinical Research
1. Introduction to Clinical Research
2. Terminologies and definition in Clinical Research
3. Origin and History of Clinical Research
4. Difference between Clinical Research and Clinical Practice
5. Types of Clinical Research
6. Phases of clinical research
7. Clinical Trials in India –The National Perspective
8. Post marketing surveillance
9. Pharmaceutical Industry – Global and Indian Perspective
10. Clinical Trial market
11. Career in Clinical Research
Module 2: Pharmacology and drug development
1. Introduction to Pharmacology
2. Concept of Essential Drugs
3. Routes of Drug Administration
4. Introduction to Drug Discovery and Development
5. Hurdles in Drug Development
6. Sources of Drugs
7. Basics of Drug Discovery & Development
8. Approaches to Drug Discovery
9. Evolutionary Classification of the strategies for Drug Discovery
10. Emerging technologies in Drug Discovery
11. Preclinical Testing
12. Investigational New Drug Application
13. Clinical trials
14. New Drug Application and Approval
15. Pharmacokinetics
16. Pharmacodynamics
17. Recent advances – Pharmacogenomics and Protein based therapies
Appendix I FDA 1571 Investigational New Drug Application
Appendix II FDA 1572 Statement of Investigator
Module 3: Ethical Considerations and Guideline in Clinical Research
1. Historical guidelines in Clinical Research
Nuremberg code
Declaration of Helsinki
Belmont report
2. International Conference on Harmonization (ICH)
Brief history of ICH
Structure of ICH
ICH Harmonization Process
3. Guidelines for Good Clinical Practice
Glossary
The Principles of ICH GCP
Institutional Review Board / Independent Ethics Committee
Investigator
Sponsor
Clinical Trial Protocol and Protocol Amendment(S)
Investigator’s Brochure
Essential Documents for the conduct of a Clinical Trial
4. Self Assessment Questions
Module 4: Regulation in Clinical Research
1. Introduction of Clinical Trial Regulation
2. European Medicine Agency
3. Food and Drug Administration (US FDA)
4. Drug and cosmetic act
5. Schedule Y
6. ICMR Guideline
Module 5: Clinical Trial Management
1. Project Management
2. Protocol in Clinical Research
3. Informed Consent
4. Case Report Form
5. Investigator’s Brochure (IB)
6. Selection of an Investigator and Site
7. Clinical Trial Stakeholders
8. Contract Research Organization (CRO)
9. Site management organizations (SMO)
10. Ethical and Regulatory Submissions
11. Recruitment Techniques
12. Retention of Clinical Trial Subjects
13. Monitoring Visits
14. Investigator Meeting
15. Documentation in Clinical Trials
16. Regulatory Binder
17. Record Retention
18. Pharmacovigilance
19. Training in clinical Research
20. Project Auditing
21. Inspection
22. Fraud and Misconduct
23. Roles and Responsibilities of Clinical Research Professionals
Module 6: Clinical Data Management
1. Introduction to CDM
2. CRF Design
3. Clinical Data Entry
4. Electronic Data Capture
5. Data Validation
6. Discrepancy Management
7. Clinical Data Coding
8. SAE Reconciliation
9. Quality Assurance & clinical Data Management
10. Guideline & Regulation in Clinical trial data
Duration: 6 months
Eligibility:
Minimum eligibility criteria for application to the course would be either of the following:
• A postgraduate or graduate in Bioscience/Life Sciences (with any of the following subjects: Botany, Zoology, Biochemistry, Microbiology, Genetics, Biotech).
• A postgraduate or graduate with Chemistry as a subject.
• A postgraduate or graduate in Pharmacy or Pharmaceutical Sciences
• A postgraduate or graduate in Medicine.
• A graduate or equivalent degree/diploma in Nursing.
The course contains six module. Every Months student will get an assignment, total assignment will be six. Assignment can be submitted in soft copy through mail. At the end of the course candidate needs to complete their final exam at our center or from their home through online (Internet connection is required). After successful completion candidate will be awarded by the degree “Diploma in Clinical Research".
Course Fee : 20000 INR (For Indian Students), 1000 USD (For foreign Students)
| Distance Learning/Correspondence | ||||
| When | Duration | Where | Remarks | Price |
| Not Specified |
6 Months |
Distance Learning/Correspondence | Not Specified |
INR 20,000 Per Course (Taxes As Applicable) |
| Price Notes: Course Fee : 20000 INR (For Indian Students), 1000 USD (For foreign Students). | ||||
Allahabad, Civil Lines (Campus):- 128, Thornhill Road, Dhobighat, Civil Lines, Allahabad - 211001, Uttar Pradesh, India
Allahabad, Katra (Center):- Jeevan Jyoti Institute of Medical Sciences LC Code : 29001 B.K. Banerjee Marg Katra, Allahabad - 211002, Uttar Pradesh, India
Apheta Institute of Clinical Research
Apheta Institute of Clinical Research is one of the finest and premier Institute in the field of Clinical research Training. We are dedicated and committed to provide .The Best Professionals' to the Clinical Research Industry. To meet the increasing demands of professionals in the field of Clinical Research, we built up a talent pool, consisting of 'Experienced Professional Faculties'; who are committed to fulfill the challenge to meet the CRI demands.
AICR is an autonomous institute formed by a group of Clinical Research professionals, under the Apheta Educational Trust® (AET), registered under the Delhi Government.
We are providing advanced and specialized courses in Clinical Research to fulfill the huge demand of trained and qualified Professionals in India and abroad. Our extensive training provides you to enter into the Clinical Research Industry.
India is becoming a hub for Clinical Research; the demand for professionals in this field is growing rapidly. 50000 Professionals will be required by the end of 2010 financial year, as projected by Times Job. Clinical Research business in India will be worth $1 billion by 2010. Thus, there will soon be a massive demand for clinical research professionals, making it an interesting career option with massive growth potential.
