Clinical Research Courses By Distance Learning In India

What are the institutes that provides the courses of the clinical research through the distance learning mode in India please tell me as I am looking to take the admissions to the courses?

As you are looking to get the admission to the courses of the clinical research through the distance education mode so I am telling you the details of the Indian Clinical Research Institute that also provide the courses through the distance learning mode.

ICRI is the Country's premier Clinical Research Institute that is exclusively focused on specialized Clinical Research Programmes in the country.

Mission of the institute-
The institute is working so as to Provide an independent global framework for international education, training and exchange of information for Clinical Research Professionals and to foster professional excellence in design and execution of clinical research, thereby contributing to enhancing the Clinical Research culture in India.

The authorized centers of the institute are as follows –

ICRI Authorized Centers

Vishakhapatnam
Swagger Infosolutions Pvt Ltd,
DrNo: 9-14-5, Second floor,
Praveen Plaza, VIP Road,
Siripuram, Visakhapatnam- 530 003.
Contact: Enquiries
91-891-6525222/6639238
Email: inquiryvizag@icriindia.com
careeradvisor@swaggerinfosolutions.com

N.Ravi Shankar
91-9629857280
Email: rsn@swaggerinfosolutions.com

Mr.Kiran Kumar
91-9390532443
Email: kkt@swaggerinfosolutions.com

Chennai
ICRI Authorised Training Center
3a, 135, Nelson Manickam Road,
Mehta Nagar, Chennai 600 029
Contact: Ms Haritha Himachal
Phone: +91 44 23740555
Mobile: 9840292323, 9884420078
Email: enquirychennai@icriindia.com

The courses that are offered at the above mentioned centers are –

Core courses

Post Graduate Diploma in Clinical Research
Post Graduate Diploma in Health Care Management
Diploma in Clinical Research
Diploma in Health Care Management

Sub-Core Courses

Diploma in Customer Services Management (for Hospitals)
Certificate in ICHGCP

Supporting Courses

Diploma in Customer Care Excellence- Health Care Services
Diploma in Hospital Operations (for Nurses)
Diploma in Medical Tourism
Diploma in Site Services Management
Post Graduate Diploma in Clinical Research
Advanced Post Graduate Certificate in Clinical Research (for Investigator)
Advanced Post Graduate Certificate in Clinical Research
Post Graduate Certificate in Clinical Research
Diploma in Clinical Research
Advanced Certificate in Clinical Research

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Answered By StudyChaCha Member

Hello sir I want to know about the course in clinical research in distance education so please provide me some information about this.

Clinical research administration is a field that involves creating, evaluating and implementing the processes whereby potential products, such as medical devices, biological processes and drugs are evaluated.

Courses

Clinical Research Administration: Critical Analysis

Clinical Trial Management

Clinical Research Writing

Related Professional Courses

Health Systems Trends

Health Economics and Financial Management

Eligibility:

Minimum eligibility criteria for application to the course are

• A postgraduate or graduate in Bioscience/Life Sciences (with any of the following subjects: Botany, Zoology, Biochemistry, Microbiology, Genetics, and 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.

Duration of this course

The Duration of this course is generally 6 months.

Syllabus

Syllabus of clinical Research course


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


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

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Answered By StudyChaCha Member