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  • Fellowship in Clinical Research – 12 Months

    Designed by Skillversity

    Course Overview

    The Fellowship in Clinical Research is a comprehensive 12-month advanced training program designed for medical professionals and healthcare graduates who wish to build expertise in clinical research, trial methodology, and regulatory processes.

    This program provides structured training in research design, biostatistics fundamentals, ethics committee procedures, and clinical trial management. The curriculum integrates theoretical foundations with practical exposure to protocol development, data handling, and regulatory documentation.

    Eligibility Criteria

    • MBBS, BDS, BAMS, BHMS, BPT, B.Pharm, M.Pharm, Nursing, Life Sciences graduates

    • MD, DNB, or equivalent qualifications preferred

    • Professionals interested in research, academics, pharmaceuticals, or CROs

    Course Duration

    12 Months (1 Year) – Comprehensive Training

    Includes:

    • Case-based learning

    • Protocol writing workshops

    • Statistical interpretation sessions

    • Exposure to regulatory documentation

    Course Content – Module Breakdown

    Module 1: Introduction to Clinical Research

    • Evolution of clinical research

    • Types of clinical studies (observational vs interventional)

    • Phases of clinical trials (Phase I–IV)

    • Roles and responsibilities in research

    • Overview of Good Clinical Practice (GCP)

    Module 2: Research Methodology

    • Research question formulation

    • Study design selection

    • Randomization and blinding

    • Sampling techniques

    • Inclusion and exclusion criteria

    • Bias and confounding factors

    Module 3: Protocol Development & Study Documentation

    • Writing a clinical research protocol

    • Case Report Forms (CRFs)

    • Informed Consent Documents (ICD)

    • Investigator Brochure basics

    • Study timelines and milestones

    Module 4: Biostatistics – Basics

    • Types of data and variables

    • Descriptive statistics

    • Probability and distributions

    • Hypothesis testing

    • p-value and confidence intervals

    • Sample size calculation basics

    Module 5: Applied Biostatistics in Clinical Research

    • Parametric and non-parametric tests

    • T-test, Chi-square, ANOVA basics

    • Correlation and regression

    • Interpretation of statistical outputs

    • Introduction to statistical software

    Module 6: Ethics Committee & Regulatory Process

    • Institutional Ethics Committee (IEC) structure

    • Submission process for ethical approval

    • Informed consent process

    • Vulnerable populations in research

    • Regulatory authorities and guidelines

    • Adverse event reporting

    Module 7: Good Clinical Practice (GCP) & Compliance

    • ICH-GCP guidelines

    • Roles of sponsor, investigator, and CRO

    • Monitoring and auditing

    • Protocol deviations and violations

    • Documentation standards

    Module 8: Clinical Trial Management

    • Study start-up procedures

    • Site selection and feasibility

    • Patient recruitment strategies

    • Study coordination

    • Trial monitoring and quality control

    • Data management systems

    Module 9: Pharmacovigilance & Safety Reporting

    • Adverse events (AE) and serious adverse events (SAE)

    • Causality assessment

    • Safety reporting timelines

    • Risk management plans

    • Post-marketing surveillance basics

    Module 10: Data Management & Research Reporting

    • Data collection and validation

    • Electronic Data Capture (EDC) systems

    • Data cleaning and query resolution

    • Clinical Study Reports (CSR)

    • Publication writing basics

    Module 11: Systematic Reviews & Evidence-Based Medicine

    • Literature search strategies

    • Critical appraisal of research articles

    • Meta-analysis basics

    • Levels of evidence

    • Translating research into clinical practice

    Module 12: Practical Training & Dissertation Project

    • Protocol drafting workshop

    • Ethics submission mock exercise

    • Statistical interpretation practice

    • Case-based clinical trial simulations

    • Mini research project or dissertation

    • Final assessment and viva

    Hands-On Training & Practical Exposure

    • Protocol writing workshops

    • Ethics submission simulations

    • Biostatistics interpretation exercises

    • Clinical trial documentation training

    • Case-based discussions

    Certification & Career Opportunities

    Upon successful completion, participants will receive:

    Skillversity Fellowship in Clinical Research

    Career pathways include:

    • Clinical Research Coordinator (CRC)

    • Clinical Research Associate (CRA)

    • Pharmacovigilance Officer

    • Medical Writer

    • Research Associate in Academic Institutions

    • Roles in Pharmaceutical & CRO industries

    Why Choose Skillversity?

    • Structured, industry-oriented curriculum

    • Practical exposure to research documentation

    • Training aligned with GCP standards

    • Case-based learning approach

    • Career guidance for research and pharma sectors