Introduction to Clinical Research
Clinical research studies the safety and effectiveness of new medicines, treatments, and medical devices through carefully designed trials. It combines science, ethics, and data analysis to improve patient care, support regulatory approvals, and advance evidence-based healthcare worldwide.
- Introduction to Clinical Research
- Terminologies in Clinical Research
- Advantages of CR in India
- Introduction to Clinical Research- Notes
- Introduction to Clinical Research Quiz
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Comprehensive Course Curriculum
Good Clinical Practice (GCP)-ICH E6
Pharmacovigilance
Monitoring of Trials
Drug Development Process
Clinical Data Management
Regulatory Affairs
Protocol Designing
Good Clinical Practice (GCP)-ICH E6
- History Development of International Regulations in Clinical Research
- Good Clinical Practices
- Ethics committee
- Investigator Responsibilities
- Sponsor Responsibilities
- Protocol and Investigator Brochure
- Essential Documents
Pharmacovigilance
- Adverse Event Reporting
- Recording of Event
- Medical Management of Adverse Events
- Handling Death
- Unblinding of Drug
- Clinical Safety and Pharmacovigilance
- E2A- Clinical Safety and Data Management
- Media 436
- Naranjo Assessment
- Order and Formulate to Determine the Quantum
Monitoring of Trials
- Audits and Inspections
- Flow of Events
- Investigational Drug Management
- Routine Monitoring Visits
- Site Visit Flow
Drug Development Process
- Overview of Drug Development
- Clinical trial phases
- BA/BE Studies
- Drug Development Notes
- Drug Development Quiz
Clinical Data Management
- CFR Part 11
- CRF_Design_2
- Introduction to CDM
- Data Entry Methods
- Query Management
- Source data validation
- Future of Data Management
Regulatory Affairs
- Application of Permission
- Approval of Clinical Trial
- CDSCO
- Code of Federal Regulation (CFR)
- CT_Rules_2019
- ICMR Guidelines
- Medical Devices
- ICMR Guidelines
- DoH Oct 2013
- Guidelines for Industry
Protocol Designing
- Drafting a study protocol
- Study Design
- Informed Consent
- Design of Trial- Notes
- Protocol Designing- Quiz
Frequently Asked Questions
A clinical research course at ICRB is a specialized training program focused on providing comprehensive knowledge and skills for conducting research in medical and healthcare domains.
Industry-recognized certification, 15+ years experienced trainer, unlimited placement calls through 100% job assistance, life time access to the course.
Clinical Research, Monitoring of Trials, Drug Development Process, Data Management, Pharmacovigilance, ICH-GCP, Regulatory Affairs, Protocol Designing and Etc.
B. Pharm, M. Pharm, BSc, MSc (Bio/Micro), Nursing, BDS, MBBS, BHMS or Any life science graduate.
clinical research associates, Pharmacovigilance officer, project managers, data analyst, and regulatory affairs specialists & Etc.
Our Course available in both mode offline/online.
Yes, we have flexible timing for our course.