Description
The Post Graduate Diploma in Clinical Research (PGDCR) is an online eLearning course that covers the core areas of the clinical research process and equips you to start a career as a Clinical Research Professional. The course is aligned to the requirements of the industry and imparts clinical research process knowledge in a clear and concise manner so that you may kick-start a career in clinical research.
This course provides 24×7 access to the Oracle Siebel Clinical CTMS software used as a de-facto standard for managing clinical trial data.
The Diploma in Clinical Research program is made up of 18 modules, 143 topics and 100 Quizzes. It lays a strong foundation by covering the concepts of Epidemiology, Pharmaceutical medicine and Therapeutic Areas. This is followed by an Overview of Clinical Research, Ethics and Guidelines, Roles and Responsibilities as well as the processes that are a part of managing clinical trials.
The course covers in detail the process of clinical trial preparation, Study startup, Trial monitoring, Audits and Inspection and Regulatory documentation & Submission. It covers all components of clinical research including clinical trial management, clinical data management, regulatory affairs as well as Project & Financial management.
The final module of the course covers the process of managing clinical trial data using the Oracle Siebel Clinical application. This module covers all the clinical trial management tasks performed in Oracle Siebel Clinical including Site management, Visit Tracking, Budgeting, Protocol and CRF management and maintaining Drug Accountability.
On completing your enrolment for the Diploma in Clinical Research program you will instantly get access to our online learning portal and the Oracle Siebel Clinical software.
Find more information about the field of Clinical Research – What is Clinical Research
Curriculum
Course Stats – 18 Modules, 143 Chapters, 100 Quizzes
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 – Epedemiology and Evidence Based Medicine (EBM)
- Epidemiology 1 – Introduction
- Epidemiology 2 – Concept of Causation
- Epidemiology 3 – Epedemiological Study Designs
- Epidemiology 4 – Statistics
- Evidence Based Medicine
Module 3 – Pharmaceutical Medicine
- Introduction to Pharmaceutical Medicine
- Pre-clinical 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 Enviroment 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
Course Completion
- Final Assessment
- Course Certification
Certification
At the end of the course, students will be awarded a certificate of completion.
Duration
The duration of this program is 3 months.
You will have access to the course, and Oracle Siebel Clinical software for the duration of the program.
Elena Davis –
It’s a comprehensive course in clinical research and the content is exhaustive. Recommend it if you want a deep dive into the clinical research domain.
Otso –
Interactive modules make this course a top choice for anyone seeking a thorough understanding of clinical research methodologies and industry best practices.
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.
Palki Sharma –
Detailed course and good support where required through discussion forums.
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.
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!
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.
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.
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!
Mike Dallas –
Provided 24×7 access to Oracle Siebel Clinical for practice as promised. Appreciate it!
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!
Trisha Patil –
Great course but too detailed. Could not complete in 3 months.
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!
Shreya Deshpande –
Comprehensive program!
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.