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    Clinical Trials

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    Ayush Jain
    This course provides an overview of clinical trials and data management. The course objectives are to provide insight into the basic and operational aspects of clinical trials and expose students to quality systems and ethical challenges. The course covers the basics of clinical trials, statistics, conducting trials in practice, project management, case report forms, and quality audits. Assessment is based on a class test, viva, homework, and attendance, with the end term exam accounting for 70% of the total grade. The course aims to help students understand clinical trials and independently carry out related responsibilities.

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    Clinical Trials

    Uploaded by

    Ayush Jain
    233 views3 pages
    This course provides an overview of clinical trials and data management. The course objectives are to provide insight into the basic and operational aspects of clinical trials and expose students to quality systems and ethical challenges. The course covers the basics of clinical trials, statistics, conducting trials in practice, project management, case report forms, and quality audits. Assessment is based on a class test, viva, homework, and attendance, with the end term exam accounting for 70% of the total grade. The course aims to help students understand clinical trials and independently carry out related responsibilities.

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    This course provides an overview of clinical trials and data management. The course objectives are to provide insight into the basic and operational aspects of clinical trials and expose students to quality systems and ethical challenges. The course covers the basics of clinical trials, statistics, conducting trials in practice, project management, case report forms, and quality audits. Assessment is based on a class test, viva, homework, and attendance, with the end term exam accounting for 70% of the total grade. The course aims to help students understand clinical trials and independently carry out related responsibilities.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    233 views3 pages

    Clinical Trials

    Uploaded by

    Ayush Jain
    This course provides an overview of clinical trials and data management. The course objectives are to provide insight into the basic and operational aspects of clinical trials and expose students to quality systems and ethical challenges. The course covers the basics of clinical trials, statistics, conducting trials in practice, project management, case report forms, and quality audits. Assessment is based on a class test, viva, homework, and attendance, with the end term exam accounting for 70% of the total grade. The course aims to help students understand clinical trials and independently carry out related responsibilities.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
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    The key takeaways are that the course aims to provide an understanding of the basic and operational aspects of clinical trials including study design, data management, quality assurance, and regulations.

    The objectives of the course are to give insight into the basic and operational aspects of a clinical trial and expose students to quality systems and ethical challenges of clinical trials.

    The course covers topics like the basics of clinical trials, statistics, project management, case report forms, quality audits, and data management.

    Course Title: Clinical Trails and Data Management

    P/
    S

    SW/F
    W

    03

    TOTAL
    CREDIT
    UNITS
    03

    Course Objectives:
    Course is intended to give an insight into the basic and operational aspects of a clinical trial. This is mandatory as any drug/ novel interventions must generate
    safety and efficacy data in a highly controlled scenarios such as clinical trial. The student would also be exposed to the quality systems and ethical challenges
    confronting the conduct of clinical trial.
    Pre-requisites: UG in Bioinformatics/Biotechnology/Biomedical Science
    Student Learning Outcomes:
    Demonstrate a reasonably good understanding about the basic aspects of clinical trial
    Translate knowledge and understanding about the conduct of the clinical trial to independently carry out the responsibilities related to it.
    Course Contents/Syllabus- Theory:
    Weightage (%)
    Module I
    10
    Descriptors/Topics: Basics of Clinical Trials
    Fundamental principles of comparative clinical trials in investigating effectiveness, efficacy and safety of treatments,
    benefits, types and phases of clinical trials.
    Module II
    20
    Descriptors/Topics: Basic statistics for clinical trials
    How to select and apply appropriate statistical methods to analyse data from clinical trials, presenting, interpreting and
    discussing the analyses clearly and concisely.
    Module III

    20

    Descriptors/Topics: Clinical trials in practice


    Review systems applicable to clinical trial, various principles of Clinical trials as per ICMR guidelines, Key steps in
    implementing a clinical trial: Informed Consent Form, Budgeting of clinical trial, trial governance, clearances
    (including research and ethical clearance), Protocol development. Trial designs: use of different trial designs such as
    non-inferiority and equivalence, cross-over, factorial, multi-armed and cluster randomised trials and data collection and
    recruitment methods. Quality assurance and control, data processing, management issues including post-trial
    monitoring.
    Module IV
    Descriptors/Topics: Project Management

    20

    Data management plan, Project management for the clinical data manager, Vendor selection and management, Data
    management standards in clinical research, Design and development of data collection, Edit check design principles.
    Module V

    20

    Descriptors/Topics: Case Report Forms


    CRF Completion Guidelines, CRF printing and vendor selection, Data validation, programming and standards,
    Laboratory data handling, External data transfer, Patient-reported outcomes, CDM presentation at investigator meetings,
    Metrics for clinical trials, Systems Software Validation Issues Clinical Trials Database Environment.
    Module VI

    10

    Descriptors/Topics: Quality Audits


    Audit Definition, types & procedures, Audit standards, Audit trail & its role in authenticity
    of data, Audit plan,
    Audit by regulatory authorities, GMP, GDP & logistics, Preparing and delivering audit reports, What makes a good
    audit, New product development & GxP Regulations.
    Pedagogy for Course Delivery:
    The class will be taught using theory and practical method. In addition to solving practical problems, the course instructor will spend considerable time in
    understanding the concept of clinical trials.
    Lectures: 43
    Tutorial:
    Presentation/ Seminar: 1
    Class Test: 1

    Total: 45
    Assessment/ Examination Scheme:
    Theory L/T (%)

    Lab/Practical/Studio (%)

    Total (%)

    100%
    Theory Assessment (L&T):

    NA

    100%

    Continuous Assessment/Internal Assessment


    Components (Drop
    down)
    Weightage (%)

    End Term
    Examination

    Class Test 1

    Viva

    Home Assignment

    Attendance

    10

    10

    5
    70

    Text & References :

    Clinical Data Management Richard K. Rondel , Sheila A. Varley , Colin F. Webb ISBN: 978-0-470-85335-1
    Susanne Prokscha (2011), Practical Guide to Clinical Data Management, Third Edition, CRC Press; 3 edition (18 November 2011), ISBN-13: 9781439848296.
    Richard K Rondel (2000) Clinical Data Management, Second Edition. Wiley Publishing House. ISBN: 978-0-470-85335-1.

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