Post Graduate Diploma in Clinical Trial Monitoring

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.

It is an online post graduate Diploma course. It includes 3 months online sessions.

Syllabus

Course Curriculum includes

Design and Development of Drug

• Fundamentals of Drug Developments

• CGMP

Preclinical Studies

• Preclinical studies

• Preclinical toxicology

• IND application

Clinical Research Introduction

• History and Introduction to clinical trials

• Definitions and Terminologies

• Types and scope of clinical research

• Evolution of clinical research

• GCP

Clinical trials

• GCP in depth

• Responsibility of Sponsor

• Responsibility of Investigator

• Informed consent

• IP Accountability

• Role and responsibilities of CRA

• Role and responsibilities of CRC

• Essential documents and sources in clinical trial

• Protocol design

• Trial design

• Interim Analysis

• NDA

Quality, Regulations and Ethics

• Quality assurance unit and responsibility

• SOPs

• Assurance of Data quality

• Audits and inspections

• Regulations in clinical trials

• Indian regulatory system

• US-FDA Guidelines for clinical trials

Teaching Mode

• 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