Post Graduate Diploma in Clinical Trial Monitoring

Postgraduate Diploma by ACRI (Avigna Clinical Research Institute) Bangalore View Contact

Starting from: INR 25,000 Per Course (Taxes As Applicable) Request Info

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

ACRI (Avigna Clinical Research Institute)

Avigna Clinical Research Institute is modeled on the lines of some of the premier Clinical Research Institutes of India. We are dedicated and committed to provide excellent Clinical Research Professionals to the Clinical Research Industries.
Students and Professionals from the Health Science/Allied Health Science/Life Science can look forward to a robust curriculum and training in the area of Clinical Research coupled with additional training in soft skills and internships in leading Clinical Research Organizations.