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Diploma in Clinical Research

(14 customer reviews)

$799.00

Includes 24×7 access to Oracle Siebel Clinical CTMS for hands-on practice.

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Description

The Diploma in Clinical Research is a comprehensive online program designed to build knowledge and practical skills across the clinical trial lifecycle. The program combines structured, self-paced learning with quizzes, assessments and hands-on experience using Oracle Siebel Clinical CTMS.

Covering 18 modules, 143 topics and 100 quizzes, the program begins with the foundations of clinical research, epidemiology, pharmaceutical medicine and therapeutic areas before progressing to ethics, Good Clinical Practice, clinical trial preparation, study start-up, monitoring, regulatory submissions, compliance and audits.

You will also explore clinical data management, biostatistics, regulatory affairs, medical device trials, project and vendor management, and financial management of clinical trials—providing a broad understanding of how different functions contribute to the planning and management of clinical research.

Program at a Glance

18 Modules | 143 Topics | 100 Quizzes

3 Months | 24×7 Software Access | Certificate of Completion

What You’ll Learn

By completing the program, learners will develop an understanding of:

  • Clinical research fundamentals and the clinical trial lifecycle
  • Good Clinical Practice, ethics and informed consent
  • Clinical trial preparation and study start-up
  • Essential documents and regulatory submissions
  • Site monitoring and clinical trial management
  • Compliance, audits and standard operating procedures
  • Clinical data management and biostatistics
  • Regulatory affairs across major markets
  • Medical device clinical trials
  • Project, vendor and financial management
  • Applying clinical trial management concepts using Oracle Siebel Clinical CTMS

Who Is This Program For?

The Diploma in Clinical Research is suitable for:

  • Students and graduates interested in developing knowledge of clinical research
  • Life sciences, pharmacy, medical and healthcare graduates
  • Healthcare professionals exploring clinical research
  • Professionals transitioning into clinical research or clinical operations
  • Clinical research professionals looking to strengthen their understanding across multiple functional areas
  • Learners seeking hands-on exposure to Clinical Trial Management System software

Gain Hands-On Experience with Oracle Siebel Clinical

The program includes 24×7 access to Oracle Siebel Clinical, a Clinical Trial Management System (CTMS), for the duration of the program.

Through dedicated software training and hands-on practice, you will explore key clinical trial management activities including site management, visit tracking, budgeting, protocol and CRF management, and drug accountability. This practical component helps you connect clinical research concepts with their application in a clinical trial management environment.

Upon enrolment, you receive access to the ClinSkill online learning portal and Oracle Siebel Clinical software so you can begin learning and practising at your own pace. New to clinical research? Learn about the field, clinical trials and the role of clinical research professionals in our What Is Clinical Research? guide.

Explore more Clinical Research courses and training programs.

Key Features

  • Comprehensive clinical research curriculum covering the clinical trial lifecycle
  • 18 modules, 143 topics and 100 quizzes
  • Multimedia tutorials and structured self-paced learning
  • 24×7 access to Oracle Siebel Clinical CTMS
  • Hands-on software training in clinical trial management activities
  • Quizzes and assessments to reinforce learning
  • Instructor support through discussion forums
  • Certificate of completion

Curriculum

Module 1 – General Introduction
  • Pharmaceutical & CR – Industry Overview
  • Introduction to Clinical Research
  • Stakeholders and Roles in Clinical Research
  • History and Milestones in Clinical Research
  • Principles of Good Clinical Practice
  • Technologies in Clinical Trial Management
  • Overview of Clinical Research Regulatory Bodies
Module 2 – Epidemiology and Evidence Based Medicine (EBM)
  • Epidemiology 1 – Introduction
  • Epidemiology 2 – Concept of Causation
  • Epidemiology 3 – Epidemiological Study Designs
  • Epidemiology 4 – Statistics
  • Evidence Based Medicine
Module 3 – Pharmaceutical Medicine
  • Introduction to Pharmaceutical Medicine
  • Preclinical Development of Drugs and Biologics
  • Clinical Phases of Drug Development
  • General Pharmacology
  • BA-BE Studies
  • Pharmacogenetics-Pharmacogenomics
  • Toxicology
  • Systemic Pharmacology
  • Clinical Trial Design
  • Intellectual Property Rights
  • Personalized Medicine
  • Clinical Trials in Pediatrics
  • Drug Safety in Pregnancy
  • Research Methods for Genetics Studies
  • Stem Cell Research and its Applications
  • Endpoints in Clinical Trials
  • Clinical Trial Registries
Module 4 – Therapeutic Areas
  • Introduction to Health and Disease
  • Endocrinology 1
  • Endocrinology 2 (Diabetes)
  • Cancer Biology
  • Cardiovascular Medicine
  • Respiratory Medicine
  • Psychiatry
  • Neurology
  • Women’s Health
  • Infectious Diseases
  • Dermatology
Module 5 – Ethics in Clinical Research
  • Ethics in Clinical Research
  • Informed Consent Process
  • International Conference for Harmonization
  • Schedule-Y
  • ICMR Guidelines
Module 6 – Roles and Responsibilities
  • Investigator Responsibilities
  • Sponsor-Vendor Responsibilities
  • IRB Responsibilities
  • Role of Clinical Research Personnel
Module 7 – Clinical Trial Preparation
  • Clinical Study Protocol – Protocol Writing
  • CRF Design
Module 8 – Essential Documents and Regulatory Submission
  • Essential Documents
  • IND Submission
  • Clinical Study Report (CSR)
  • NDA Submission
Module 9 – Study Start-up
  • Study Feasibility and Site Selection
  • Pre-Study Visit
  • Site Initiation
  • Informed Consent Process
  • Subject Recruitment and Retention
  • Trial Master File
Module 10 – Clinical Trials Monitoring
  • Routine Site Monitoring
  • CRF Review and Source Data Verification
  • Drug Accountability
  • Safety Reporting and Pharmacovigilance
  • Site Close-out
Module 11 – Compliance and Audits
  • Site Audit and Overview
  • Sponsor Compliance and Audit
  • Standard Operating Procedures (SOP) in Clinical Research
  • Electronic Records and Signatures
  • Conflict of Interest
Module 12 – Data Management and Biostatistics
  • Data Management Overview
  • Introduction to Biostatistics
  • Data Analysis and Reporting
Module 13 – Regulatory Affairs in Clinical Research
  • Regulatory Environment in the US
  • Regulatory Environment in Europe
  • Regulatory Environment in India
Module 14 – Medical Device Trials
  • Medical Devices – Definition and Lifecycle
  • Global Regulatory Strategy for Medical Devices
  • Medical Device – Trial Design Considerations
Module 15 – Project and Vendor Management
  • Fundamentals of Project Management
  • Integrated Project Management
  • Clinical Research Outsourcing – Vendor Selection
  • Clinical Research Outsourcing – Vendor Management
  • Clinical Trial Supplies
Module 16 – Financial Management of Clinical Trials
  • Accounting for Managers
  • Clinical Trial Budgeting
  • Clinical Trials Marketing
  • Indemnity and Compensation
Module 17 – Personality Development and Communication Skills
  • Understanding Self
  • Self-esteem
  • Emotional Intelligence
  • Attitude
  • Leadership
  • Interpersonal Relationships
  • Group Dynamics and Team Building
  • Stress Management
  • Performance Appraisal
  • Time Management
  • Conflict Management
Module 18 – Oracle Siebel Clinical CTMS
  • Siebel Clinical – Application Overview
  • Siebel Clinical – Business Solution Footprint
  • Siebel Clinical for Clinical Trial Management
  • Siebel Clinical Fundamentals
  • Siebel Clinical Fundamentals – Session 1
Course Completion
  • Final Assessment
  • Course Certification

Certification

Upon successful completion of the program and final assessment, learners receive a ClinSkill Certificate of Completion.

Duration

The program duration is 3 months, with flexible, self-paced access to the online learning portal.

You will also receive access to Oracle Siebel Clinical CTMS for the duration of the program, allowing you to practise alongside your learning.

14 reviews for Diploma in Clinical Research

  1. Otso

    Interactive modules make this course a top choice for anyone seeking a thorough understanding of clinical research methodologies and industry best practices.

  2. James Abney

    This clinical research course offers a comprehensive and practical approach, equipped me with invaluable skills for navigating the complex landscape of clinical trials effectively. The access to the Oracle Siebel Clinical CTMS was really valuable to me.

  3. Palki Sharma

    Detailed course and good support where required through discussion forums.

  4. Dr. Piya Rai

    Just completed this course. Industry oriented and comprehensive. Quizzes helped reflect and assess my knowledge after each topic which was appreciated. Overall would recommend.

  5. Miguel Ebola

    Access to Oracle Siebel Clinical CTMS was included in the course which was great for practical experience with the software. Learnt a lot from the course and would highly recommend it!

  6. Prateek Ranjan

    Very comprehensive course. Was a bit difficult to assimilate with my job, hence the 4 stars but having said that i believe this course covers everything one would need to know to make a career in clinical operations.

  7. Priya Bhasin

    Was able to download all tutorials on their app and learn offline. Also could take my quizzes on the go. Since i am already working and travel a lot in my role as a CRA, this was very useful.

  8. Ann Kaplan

    Extremely detailed program covering all aspects of clinical research. I am a Dentist by profession and knew nothing about this field. The program started with the very basics and built up the concepts gradually. Did not feel overwhelmed at any time. Learning portal was well organized. Course content was clear and concise. Audio Tutorials are great. Access to Oracle Siebel Clinical software was provided. Extremely satisfied!

  9. Mike Dallas

    Provided 24×7 access to Oracle Siebel Clinical for practice as promised. Appreciate it!

  10. Babu Nema

    Best part was they provided access to Oracle Siebel Clinical which is a Clinical Trial Management System (CTMS) which is being used in most CROs today. So i didn’t only learn theory, i also did the practical aspects of managing clinical research elements in the software. Recommend this course!

  11. Trisha Patil

    Great course but too detailed. Could not complete in 3 months.

  12. Payal Rohtagi

    Covers concepts from the very basics of Biology to complex processes in clinical research. The only course in clinical research your were ever need to take!

  13. Shreya Deshpande

    Comprehensive program!

  14. Gunjanika Sahu

    The course was very comprehensive and covered all the core areas of clinical research, clinical data management, regulatory affairs and pharmacovigilance. The audio tutorials helped me learn better, simply by listening to them. Quizzes after every chapter helped me assess my knowledge. Good and complete program.

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