The Clinical Research & Trials Certification Course is designed to provide a comprehensive understanding of how new medical treatments, drugs, and devices are developed, tested, and approved for public use. This program covers the entire clinical research process — from study design and ethical considerations to data management and regulatory compliance. Learners will gain practical insights into Good Clinical Practice (GCP), pharmacovigilance, clinical data analysis, and the roles of various stakeholders in research trials. Through hands-on training and industry-aligned projects, participants will develop the skills required to work in hospitals, pharmaceutical companies, research organizations, and regulatory agencies. This course is ideal for those aspiring to build a strong career in the rapidly growing field of clinical research and healthcare innovation.
Module 1: Introduction to Clinical Research Overview of the pharmaceutical research process History and evolution of clinical research Drug discovery and development process Stakeholders in clinical trials (Sponsor, CRO, Investigator, Ethics Committee) Key terminologies and concepts in clinical research.
Module 2: Clinical Trial Design and Methodology Types and phases of clinical trials (Phase I–IV) Randomization, blinding, and control groups Protocol development and study design principles Subject recruitment and informed consent process Ethical considerations in human subject research.
Module 3: Good Clinical Practice (GCP) & Regulatory Guidelines ICH-GCP principles and guidelines Roles of regulatory authorities (FDA, EMA, CDSCO, ICMR) Institutional Review Board (IRB) and Ethics Committee functions Clinical trial registration and approval process Compliance and audit procedures.
Module 4: Clinical Data Management (CDM) Data collection methods and case report forms (CRFs) Data entry, validation, and query management Database design and management using CDMS tools Data cleaning and quality assurance procedures Electronic Data Capture (EDC) systems overview.
Module 5: Biostatistics and Data Analysis Basics of biostatistics and data types Sampling methods and hypothesis testing Statistical tools: SAS, SPSS, R Analysis of variance, regression, and survival analysis Data interpretation and result presentation.
Module 6: Pharmacovigilance and Drug Safety Introduction to pharmacovigilance Adverse event reporting and signal detection Risk-benefit assessment of drugs Tools used in pharmacovigilance: Argus Safety, ArisG Case processing and safety data management.
Module 7: Clinical Trial Operations and Management Site selection, initiation, and monitoring Trial master file and documentation Budgeting and financial management in trials Roles and responsibilities of a Clinical Research Associate (CRA) Quality assurance and audit readiness.
Module 8: Regulatory Affairs and Compliance Overview of regulatory submissions (IND, NDA, ANDA) eCTD format and submission process Global regulatory frameworks (US, EU, India) Ethics in regulatory affairs Clinical trial reporting and documentation.
Module 9: Medical Writing and Communication Fundamentals of medical and scientific writing Writing clinical study reports and summaries Informed consent forms and patient information sheets Manuscript and publication writing Presentation and communication of research findings.
Module 10: Industry Case Studies & Live Project Case studies on real-world clinical trials Hands-on training with tools (Oracle Clinical, Medidata Rave, Argus) End-to-end mock trial simulation projec Report preparation and presentation Career guidance and certification assessment.
Mobile: 9100348679
Email: coursedivine@gmail.com
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