PG Diploma in Clinical Trial Monitoring :
It is an online post graduate Diploma course. It includes 3 months online sessions.
At the conclusion of this training program participants should be able to
- Identify and define the principles and requirements for GCPs.
- Define the basic roles and responsibilities of sponsor, monitor, investigators and FDA as they relate to the quality of clinical trials.
- Learn the similarities and differences in GCP for drugs, device and biologic studies.
- Understand how GCPs can impact clinical research progress and ensure that GCPs are implemented.
- Clearly put into practice the regulatory, source documentation and record-keeping requirements for clinical trials.
- Comply with informed consent and human subject protection requirements.
- Learn how to detect and prevent fraud and misconduct in clinical trials.
Applicants are recommended to have one of the following Life Science degree
Bachelor’s / Master’s / PhD / MBBS / B.D.S / B.A.M.S / B.H.M.S / Pharmaceutical Science) / B.Pharmacy / M.Sc. / B.Pharmacy / M.S
- Electronic copies will be shared to students
- Lecture slides in PowerPoint format, as used for on-campus classes, made available for Online sessions
- Additional notes arising from on-campus lectures and tutorials will be shared via mail
Weekly and Monthly Evaluation
- Test paper will be shared with the candidates on weekly basis and Monthly basis.
- A feedback barometer, through which students are enabled to provide anonymous feedback as to how the subject is progressing on a weekly basis.
Additional Features of the course
- E books and SOP’S will be shared via mail to the candidates.
- Recent updates of clinical research will be provided to the students via mail.
System Requirement for Students
- The broad band connection (512kbps and above)
- Head Set
- Link will be sent to the students email id, they have to click on the link and get connected