Clinical Research
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- Clinical Research
Clinical Research
Programme Modules
- Clinical Research Industry
- Difference between Clinical Research and Clinical Trials
- Clinical Research Terminologies
- General Medical Terminologies
- Basics of Pharmacology
- Pharmacodynamics
- Pharmacokinetics
- Routes of Administration
- Dosage forms
- Drug discovery
- Target Identification
- Lead Identification
- Lead Optimization
- Preclinical studies
- Evolution of Ethical and Regulatory Framework
- Nuremberg Code, 1946
- Declaration of Helsinki
- Thalidomide Tragedy
- Belmont Report
- Schedule Y, Drugs and Cosmetics Act 1945
- History of ICH
- ICH Guidelines
- ICH GCP- E6 R2
- ICMR Ethical Guidelines
- Ethics on use of Placebo in Clinical Trials
- CDSCO, India
- ICMR, India
- USFDA, USA
- EMEA, Europe
- MHRA, UK
- TGA, Australia
- Investigator
- Sponsor
- Contract Research Organization (CRO)
- Clinical Research Coordinator (CRC)
- Clinical Research Associate (CRA)
- Defining the Research Problem
- Sampling Design
- Hypothesis testing
- Parametric and Non parametric test
- Scientific Writing
- Diagnostic and Treatment Trials
- Interventional and Observational studies
- Case control and Cohort studies
- Randomized controlled trials
- Quasi experiments
- Essential Documents before, during and after the trial_ICH GCP
- Protocol
- Informed Consent Documents
- Investigator’s Brochure
- Case Report Form
- Clinical Study Report
- Introduction to data management
- Electronic Data Records
- E-CRF & Interactive Web Response Systems
- Database locking and unlocking
- Good Documentation Practices
- Adverse Drug Reaction
- Serious Adverse Events (SAE)
- SAE Reporting timelines
- Pharmacovigilance methods
- Signal Detection and Data Mining
- PvPI
- Risk Management Plan
- Introduction to Quality Management System
- Quality Assurance
- Quality Control
- Audits and Inspection
- Types of Audits
- General Audit Observations
- Pharmacoepidemiology- Methods
- Clinical Application of Pharmacoepidemiology
- Principles of pharmacoeconomic analysis
- Pharmaceutical Outcomes evaluations
- Medical Devices Rules, 2017
- Classification of Medical Devices
- Materiovigilance
- Phases of Medical Device Clinical Trials
- Case reports
- Article writing
- Designing Clinical Trial protocol
- CRF Designing
- Informed Consent Documents
- Clinical Study Reports
- E-Consent (Audio visual consent)
- E-Patient Reported Outcomes (e-PRO)
- IWRS
- Telemedicine
- Patient e Diaries
- Remote Patient Monitoring
- ICH-GCP_E6 R3
- NDCT Rules: 2019 & its Amendment (2023)
- ICMR-HMSC
- Recent CDSCO Notices
- NABH Ethics Committee Standards, etc.
