Training Goals & Objectives

The CRA Training Course provides students with the training and Certification necessary for the monitoring of clinical trials globally 

Graduates will be able to:- 

• Understand the drug development process and the roles and responsibilities of the CRA.

• Identify ethical issues in clinical research and their impact on the development of new products.

• Institute and obtain proper Informed Consent.

• Understand the latest Good Clinical Practices (ICH-GCP).

• Learn to employ efficient subject recruitment methods.

• Develop suitable clinical trial protocol and study budget.

• Identify adverse effects and proper reporting format.

• Appreciate the types of sponsor-investigator site visits

• Analyze and evaluate clinical data, to ensure investigator and site compliance with the protocol.

• Develop qualifications sought by the Pharmaceutical, Biotech & Medical Device industries.

Essential duties of the CRA include:

• Verify that the research site investigator(s) and study personnel are conducting the study according to the clinical protocol, “Good Clinical Practices”, and regulatory requirements to ensure protection and ethical treatment of human subjects;

• Ensure identification and reporting of safety issues, when applicable, from research site staff to the sponsor and the IRB/IEC;

• Perform monitoring activities per the monitoring plan (e.g. verification of source documents and eCRF/CRFs, site communications, follow up on data anomalies, etc.)

• Review accuracy and completeness of site records (i.e., essential documents, query resolution, and other data collection tools);

• Ensure that accountability of Investigational Product and related supplies are performed, when appropriate;

• Ensure complete reporting and proper documentation of monitoring activities;

• Conduct routine monitoring visits (on site or remotely) independently from the investigative site study staff;

• Ensure the site is identifying issues and implementing corrective and preventive actions to ensure inspection readiness.