- Program Accreditation: Post-Graduate Diploma Program
- 46 weeks – Total hours: 920
- Theory: 680 hours – Internship: 240 hours
The Clinical Research Post Graduate Diploma Program is designed for a wide range of students including International Medical Graduates (IMGs); Health Care Professionals (HCPs); and Science, Technology, Engineering and Mathematics (STEM) graduates. The program provides theoretical and practical understanding of clinical research and increases opportunities for employment and job advancement.
Students will learn how to generate and validate hypothesis; research bibliographic database; design clinical trial study; write clinical trial protocol; collect clinical research data; apply statistical tests for analysis of collected clinical research data; and work with stakeholders including pharmaceutical, biotechnology, and medical device companies; contract research organizations, regulatory agencies; principal investigators; and research institutions. Students also learn how to deal with ethical challenges, apply quality standards, submit human research ethics application, monitor clinical and safety database, assess received adverse events, familiarize with Medical Coding and MedDRA, submit safety reports to the regulatory authorities and comply with the laws, regulations, guidelines and specifications, write case narrative, Standard Operating Procedures and Internal Working Instructions, Data Safety and Monitoring Board report, Medical Monitor clinical data review checklist, Investigational New Drug Application, and Clinical Trial Application.
Successful graduates are fully prepared for diverse careers in clinical research. With a strong foundation in clinical research fundamentals, and practical experience in the clinical research environment, students will be ready for any number of careers, including jobs in the pharmaceutical industry, contract research organizations, research institutions, regulatory authorities and more.
- Previous Diploma or degree in Health Science, Public Administration, Recreation Administration or Hospital Administration.
- English proficiency requirement for international students.
To successfully meet the program outcomes the student must:
- Achieve a minimum mark of 70% in all of the module assignments and exams
- Achieve a satisfactory rating in the internship evaluation
What You Will Learn
The course consists of 22 modules. These modules are covered in the classroom and the internship.
- Study Designs in Epidemiology
- Statistics in Clinical Research
- Ethics in Clinical Research
- Hypothesis Generation and Validation
- Guidelines: Good Clinical Practice, Good Laboratory Practice, Good Documentation Practice, Good Manufacturing
- Overview: Preclinical Drug Development
- Study Designs in Clinical Research and Protocol Writing
- Clinical Operations: Introduction to Regulatory Affairs and Submission of Human Research Ethics Application
- Clinical Operations: Introduction to Pharmacokinetics
- Clinical Operations: Introduction to Pharmacodynamics
- Clinical Operations: Introduction to Product Management
- Clinical Operations: Introduction to Clinical Study Conduct
- Clinical Operations: Introduction to Clinical Data Management
- Clinical Operations: Introduction to Pharmacovigilance
- Clinical Operations: Introduction to Quality Assurance and Quality Control
- Clinical Operations: Introduction to Clinical Trial Monitoring
- Medical Monitoring
- Clinical Operations: Introduction to Regulatory Submission of Study Reports
- Medical Writing
- Microsoft Word, Excel, Outlook, and PowerPoint
- Resume Preparation, Interview Skills, and Work Ethics
- Internship: The Clinical Research students complete their education with 240 hours of internship practical work experience.
JOB FINDING WORKSHOPS ARE INCLUDED
The Clinical Research Program is approved as a vocational program under the Private Career Colleges Act, 2005.