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Diploma in Clinical Research
Eligibility : MD, MS, MBBS, BDS, BHMS, BAMS, BUMS, BPT, B.Pharma, Graduate/Post Graduate Degree in Life Sciences, Pharmacology, Pharmacy, Medical Laboratory, Nursing, Biochemistry, Microbiology, Biotechnology
Duration: 6 Months
Methodology : Weekend classes .
Examination : written exams and project work
Certificate : Certificate would be awarded upon successful completion of the program.
Job Assistance : Placement support would be provided to the successful candidates.Program Details :
This is a foundation educational program, designed for all the candidates aspiring to work in the field of clinical research or allied professions like central labs. The program provides complete overview and practical environment in the field of clinical research. The program would allow candidates to upgrade their knowledge about ICH GCP Guidelines, regulatory issues and other major aspects of clinical trials management. Selected important topics from the following groups would be covered in the program:Introduction to Clinical research
Clinical Trials Project Planning & Management
Essential Documentation in Clinical Research & Regulatory Submissions
Study Start Up Process
Clinical Monitoring Essentials
Compliance, Auditing & Quality Control in Clinical Research
Post Graduate Diploma in Clinical Research for Nurses
Duration:6 Months
Eligibility : Diploma, Graduate / Post Graduate in Nursing
Methodology: weekend classes
Examination : Written exams and project work
Certificate : Certificate would be awarded upon successful completion of the program. Program is certified & Accredited by the Pharmaceutical Society of India.
Job Assistance : Placement support would be provided to the successful candidates.Program detail :
Introduction to Clinical research
Role and Duties of Study nurse in Clinical Trials
Clinical Trials Project Planning & Management
Essential Documentation in Clinical Research & Regulatory Submissions
Study Start Up Process
Clinical Monitoring Essentials
Compliance, Auditing & Quality Control in Clinical Research
Post Graduate Diploma in Clinical Research
Eligibility : MD, MS, MBBS, BDS, BHMS, BAMS, BUMS, BPT, B.Pharma, Graduate/Post Graduate Degree in Life Sciences, Pharmacology, Pharmacy, Medical Laboratory, Nursing, Biochemistry, Microbiology, Biotechnology
Duration: 6 Months + 6 months internship
Methodology : Weekend classes(6 months). + 6 months internship (stipend shall be provided)
Examination : written exams and project work
Certificate : Certificate would be awarded upon successful completion of the program.
Job Assistance : Placement support would be provided to the successful candidates.Program detail
Introduction to Clinical Research & Phases in Clinical Research
Principles of Good Clinical Practices - ICH GCP
Ethical Considerations in Clinical Trials
Indian GCP Guidelines, Schedule Y & ICMR Guidelines
Regulations in Clinical Research
Sponsor/Investigator Responsibilities
Investigator Responsibilities
Clinical Trial Design
Protocol Design
CRF Design
Essential Documents in Clinical Research
IND Application
Clinical Study Report
NDA Submission
Informed Consent Process & Documentation
Site Selection & Pre-study Visits
Site Initiation
Subjects Recruitment & Retention Plan
Site Contracts & Budgeting
Routine Site Monitoring
CRF Review & Source Data Verification
Adverse Event Reporting
Drug Safety Reporting
Drug Accountability
Site Close-out
Standard Operating Procedures for Clinical Research
Sponsor Compliance & Audits
Site Audit
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