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Interactive play tournament
ICH-GCP E6 R2 refresher
Course particularities:
- In any convenient time, from any point and any device. ·
- The course is held as a play tournament which significantly increases the quality of information acquirement. ·
- The training is developed by experts in quality assurance for clinical trials (GCP auditors). ·
- The course contains real-life examples from clinical trials. ·
- During the course, numerous practical examples which are accumulated by the course author during inspections and audits, and discussion of problems occurring in clinical trials, will be reviewed. ·
- During the tournament, you can undergo 7 modules in all sections of Good Clinical Practice (introduction, GCP principles, Independent Ethics Committee, Investigator's responsibilities, Sponsor' responsibilities, monitoring, essential study documents including the Protocol and Investigator's Brochure). ·
- The course is held in English, and its program is maximally adapted to the requirements of international (including USA and EU) legislation in clinical trials. · You will get the opportunity to obtain maximum scores and receive presents, and prizes (e.g., free participation in The QARP seminars, and considerable discounts for participation in partners' seminars, for example, those held by association RQA). ·
- You will also get access to online canal where you can ask any question in any time and get response from our experts. · Completing 7 course modules, you will get certificate Transcelerate. · Become one of the first 10 participants and get a 30% discount. · We also provide considerable discounts for several participants (with the order starting from 3 persons)
It is useful for:
- Study investigators and coordinators with work experience at least one year.
- Employees of Sponsor companies or CRO, as well as clinical trial vendors with work experience in clinical trials at least one year.
.
Special offer for Sponsor companies and CRO!
- We can customize our course to the needs of your project (e.g., within the starting meeting or investigators' training in the beginning or during the project).
.
- Study investigators and coordinators with work experience at least one year.
- Employees of Sponsor companies or CRO, as well as clinical trial vendors with work experience in clinical trials at least one year.
.
Special offer for Sponsor companies and CRO!
- We can customize our course to the needs of your project (e.g., within the starting meeting or investigators' training in the beginning or during the project).
.
Course program
Course author - our expert.
Maxim Bunimovich
A member of the Research Quality Association, Great Britain (RQA)
QA consultant (TMQA) with a vast experience in audits and inspections of study sites in various countries worldwide, as well as, practical experience in establishment of quality management systems of CRO and sites.
QA consultant (TMQA) with a vast experience in audits and inspections of study sites in various countries worldwide, as well as, practical experience in establishment of quality management systems of CRO and sites.
Module #1
Module #1
Introduction to ICH-GCP.
Module #2
Module #2
Good Clinical Practice Principles.
Module #3
Module #3
Independent Ethics Committee/Institutional Review Board.
Module #4
Module #4
Investigator Responsibilities. Source Documents. Investigational Product. Safety Reporting. Informed Consent.
Module #5
Module #5
Sponsor Responsibilities.
Module #6
Module #6
Monitoring.
Module #7
Module #7
Clinical Trial Protocol. Investigator's Brochure. Essential Documents for the Conduct of a Clinical Trial.
What will you get?
New vision
On clinical trials planning and conduct
Real tools
We will give you real woking tools
Practical case-scenarios
Lessons-learned will help you to avoid typical mistakes in the future
Maxim Bunimovich
International GCP auditor
A member of the Research Quality Association, Great Britain (RQA)
QA consultant (TMQA) with a vast experience in audits and inspections of study sites in various countries worldwide, as well as, practical experience in establishment of quality management systems of CRO and sites.
QA consultant (TMQA) with a vast experience in audits and inspections of study sites in various countries worldwide, as well as, practical experience in establishment of quality management systems of CRO and sites.
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Registration
Do have any questions? Please write us on trainingcenter@crptrials.com
or call us in WhatsApp +34666216978 or +79119998460
or call us in WhatsApp +34666216978 or +79119998460
Any time
· In any convenient time, from any point and any device.
45 euro
The price is 45 euro. · We provide considerable discounts for several participants (with the order starting from 3 persons).
e-learning
The course is developed on the interactive game training elearning platform.
Completing 7 course modules, you will get certificate Transcelerate.
Completing 7 course modules, you will get certificate Transcelerate.
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