CRC / CRA
The one week intensive boot camp training is to immerse students and help them gain understanding of clinical research and to prepare them for a job in medical research.
Following are the objectives of the course:
- GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus)
The CITI Good Clinical Practice Course for Clinical Trials Involving Drugs and Devices
Completing the CITI GCP Course:
- Overview of New Drug Development.
- Overview of ICH GCP .
- ICH – Comparison Between ICH GCP E6 and U.S. FDA Regulations .
- Conducting Investigator-Initiated Studies According to FDA Regulations and GCP .
- Investigator Obligations in FDA-Regulated Clinical Research .
- Managing Investigational Agents According to GCP Requirements.
- Overview of U.S. FDA Regulations for Medical Devices.
- Informed Consent in Clinical Trials of Drugs, Biologics, and Devices.
- Detecting and Evaluating Adverse Events.
- Reporting Serious Adverse Events.
- Monitoring of Clinical Trials by Industry Sponsors.
- Audits and Inspections of Clinical Trials
- NIH ( National institute of health) – Certification
Objectives of the course are:
To be aware of the ethical issues involved in human subjects research.
To become familiar with the roles and responsibilities of the principal investigator and the institution.
To have an understanding of Food and Drug Administration (FDA) oversight of clinical research.
To become familiar with how developments in science and health are reported by the media and how to work effectively with reporters.
- IATA – Certification
Upon completion of this course, participants should be able to:
- Describe the regulations imposed on most laboratories and the importance of following them.
- Classify infectious substances for transport.
- Demonstrate the procedures for legally and safely shipping various infectious specimens.
- Integrate dangerous goods procedures into a laboratory.
- Complete the self-assessment quiz, which enables participants to obtain the “Dangerous Goods Shipping” certification.
- CITI – Certification
- CRC (Level 1) – Certification
The programme offers a comprehensive introduction to the operations of clinical trials. The application of core CRC skills is reinforced through classroom discussions, case scenarios, demonstrations and practice-based activities. This is also valuable for individuals seeking a new career as CRC.
- Counselling for opportunities abroad such as United States of America
- On site job support for 6 months
The one week intensive course is offered in India in the following cities:
Hyderabad, Delhi, Mumbai, Bengaluru, Chennai and in USA.
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USA: 001 (312) 823-6800
INDIA: +91 7032779158