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CRA – Monitoring and Coordinating Clinical TrialsCourse # 76
Evening Course
Join the future technologies of the medical world. The accelerated development rate of drugs, biological products and medical devices leads to a steep increase in the number and magnitude of the clinical trials conducted around the world and in Israel. Developers, manufacturers and health authorities need information to enable the marketing of safe and efficient medicinal products. The clinical trial...Continue reading
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Issues to be covered
- Introduction: concepts, terms, definitions
- Regulatory Requirements
- The Israeli Ministry of Health
- The USA, European Community and other Countries
- GCP – Good Clinical Practice: the basic guidelines and rules for conducting a clinical trial around the world
- IRB – International Review Board: Ethical Committees, Helsinki Committees
- The Sponsor, The Investigator
- Monitoring of clinical trials – management of the trial’s protocol and visits for identification and selection of investigators and study sites; site visits for trial initiation, monitoring visits, closure visits.
- Informed Consent, Flow of Information
- Essential Documentations: Trial’s protocol, Amendments, medical records, study data, investigator’s brochure, reports and queries
- Pharmacy, Drug Control
- The rule of the Laboratory in clinical trials
- The Coordinator
- Risk Management
- Electronic Records and Signatures, Validation of Software
- Medical Introductions: Basic Concepts and Updated Information in various Clinical trials fields in different medical professions
Prior Education Requirements:
- Graduate of Life or Nature Sciences, Medicine, Pharmacy, nursing or equivalent fields
- English literate
The Graduate Diploma
will be given to graduates of the course who will complete the following tasks:Grade 70% and up in the final exams
Grade “Pass” in the course’s Project
Participation of 80% and up in classes
Who should attend
Physicians, Professionals from the Life and Nature Sciences, Pharmacists and nursing professionals who are interested in knowing the field of clinical trials and / or looking for a change in their career and becoming CRAs.
Benefits to the Participants
- Understanding terms and concepts of the clinical trials field
- Acquaintance with the regulatory requirements, and ‘in depth’ knowledge of the international requirements of the GCP – Good Clinical Practice
- Acquiring a wide overview of monitoring clinical trials
- Acquiring tools for management of the different stages of the trial
- Acquiring a new, interesting and required profession in a dynamic, developing field with promotion opportunities and a well financial honorarium
About The Lecturer
7 Comments on "CRA – Monitoring and Coordinating Clinical Trials"
Could you send me the dates and the co ditions for the nexr cra course
Hi please can you send me your dates for the CRA course
Thank you Ofra,
The next CRA course will start on March 31. Details here
Hello, is this course still available? I am interested in becoming certified.
Dear Susan,
Thank you for your interest in our CRA course.
please see updated details of the upcoming CRA course here: https://bioforum.org.il/course/cra83/
Bioforum team
Interested in becoming CRA certified. I’m a new Oleh and worked as a nurse for 11 years.
Hi Leah, Thank you for your interest in our CRA course.
Your background in nursing will fit the course and the field.
We’ll send you more information to your email.
– Bioforum staff