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)
Course Content:
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:
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To be aware of the ethical issues involved in human subjects research.
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To become familiar with the roles and responsibilities of the principal investigator and the institution.
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To have an understanding of Food and Drug Administration (FDA) oversight of clinical research.
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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.
Register Now Hurry up! Limited Seats Available.
Contact Us Now!
USA: info@clinicalresearchacademy.com
INDIA: afathima@clinicalresearchacademy.com
drwadood@clinicalresearchacademy.com
USA: 001 (312) 823-6800
INDIA: +91 7032779158