| Duration | 10-12 Months/Yearly | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Eligibility | Graduation in the Medical science courses (MBBS, BDS etc.) or Graduate in Science, Pharmacy, Life Sciences, Pharmacology, Biotechnology etc . With at least 55% from a Recognized Institution. |
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| Admission Process | Based on Merit & Entrance Exam in Some College |
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| Fees Detail | INR 50,000 Annually |
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| Syllabus | Diploma in Clinical Research: SyllabusA typical Diploma in Clinical Research syllabus is written below –
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| Salary | INR 2,50,000- INR 5,00,000 per Annum |
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| Recruitment | Clinical Research Laboratories, Academic Institutes, Private clinics, nursing homes, government hospitals, medical writing etc. |
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| Admission Mode |
A typical Diploma in Clinical Research syllabus is written below –
| Unit -1 - Introduction to clinical research | Clinical Trial Terminologies |
| Drug Discovery & Development | |
| CPCSEA Guideline & Pre-clinical Trials | |
| Introduction to Toxicity Studies | |
| Definition of clinical trial | |
| History of Clinical research | |
| Different Phases of clinical research | |
| Subtypes of Phase 1,2 and 3 | |
| Phase 4 | |
| Career in Clinical Research | |
| Unit -2- Pharmacology and drug development | Introduction to Pharmacology |
| Concept of Essential Drugs | |
| Routes of Drug Administration | |
| Introduction to Drug Discovery and Development | |
| Hurdles in Drug Development | |
| Sources of Drugs | |
| Basics of Drug Discovery & Development | |
| Preclinical Testing | |
| Clinical trials | |
| Pharmacodynamics & Pharmacokinetics | |
| Recent advances – Pharmacogenomics and Protein based therapies | |
| Unit -3 - Ethics and Guidelines in Clinical Research | Historical guidelines in Clinical Research |
| International Conference on Harmonization (ICH) | |
| Guidelines for Good Clinical Practice | |
| Unit -4 - Regulation in Clinical Research | Introduction of Clinical Trial Regulation |
| European Medicine Agency | |
| Fats Food and Drug Administration (US FDA) | |
| Drug and cosmetic act | |
| Schedule Y | |
| ICMR Guideline | |
| Unit - 5 - Clinical Trial Management | Project Management |
| Protocol in Clinical Research | |
| Informed Consent | |
| Case Report Form | |
| Investigator’s Brochure (IB) | |
| Selection of an Investigator and Site | |
| Clinical Trial Stakeholders | |
| Site management organizations (SMO) | |
| Ethical and Regulatory Submissions | |
| Recruitment Techniques | |
| Retention of Clinical Trial Subjects | |
| Training in clinical Research | |
| Project Auditing | |
| Roles and Responsibilities of Clinical Research Professionals | |
| Unit -6 - Clinical Data Management & Biostatistics | Introduction to CDM |
| CRF Design | |
| Clinical Data Entry | |
| Electronic Data Capture | |
| Data Validation | |
| Clinical Data Coding | |
| SAE Reconciliation | |
| Quality Assurance & clinical Data Management | |
| Guideline & Regulation in Clinical trial data |
Many colleges are offering this course in India. Some of the top colleges offering this course are listed below –
| College Name | Fee |
|---|---|
| ICRI Mumbai | INR 1,08,000 |
| IGMPI, Noida | INR 1,20,000 |
| ICRI , New Delhi | INR 1,08,000 |
| ICRI, Bangalore | INR 1,08,000 |
| Bioinformatics Institute of India(BIT) , Noida | INR 30,000 |
Many colleges are offering this course in India. Some of the top colleges offering this course are listed below –
| College Name | Fee |
|---|---|
| ICRI Mumbai | INR 1,08,000 |
| IGMPI, Noida | INR 1,20,000 |
| ICRI , New Delhi | INR 1,08,000 |
| ICRI, Bangalore | INR 1,08,000 |
| Bioinformatics Institute of India(BIT) , Noida | INR 30,000 |
Many colleges are offering this course in India. Some of the top colleges offering this course are listed below –
| College Name | Fee |
|---|---|
| ICRI Mumbai | INR 1,08,000 |
| IGMPI, Noida | INR 1,20,000 |
| ICRI , New Delhi | INR 1,08,000 |
| ICRI, Bangalore | INR 1,08,000 |
| Bioinformatics Institute of India(BIT) , Noida | INR 30,000 |