brookwood’s online gcp training solutions€¦ · essential gcp a narrated online, on demand...
Post on 16-Apr-2018
217 Views
Preview:
TRANSCRIPT
www.brookwoodtraining-online.netwww.brookwoodtraining-online.net
KEY FACTS Our ICH E6 GCP investigator site
training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors.
Some of our courses have been awarded CPD credits by the Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians of the United Kingdom.
Regulators, major sponsors, academic units use the training for their clinical research teams.
More than 30,000 investigators have now undertaken our online GCP training and received certification.
Essential GCP with exam and certification – available in 11 languages
Learn and Refresh GCP using Q&A – versions for sponsors, administrators, investigators and senior managers
Learn & Refresh UK Clinical Trial Regulations
GCP Problem Solving
Investigator Oversight
Good Laboratory Practice
OUR COURSES
Want to test drive any of the courses? Contact us at:
info@brookwoodacademy.org
ABOUT USBrookwood International Academy is an independent Academy specialising in clinical research and Good Clinical Practice (GCP) training and certification. We provide Training – Examinations – Certification – Continuing Education – Online learning with certification.
Brookwood’s excellent reputation as a training organisation has been gained since 1985. We have undertaken training at individual and corporate levels for many major pharmaceutical companies, universities and other academic organisations, regulators, inspectors and members of ethics committees. We have trained investigators from more than 60 countries worldwide and continue to provide education to two major regulatory authorities.
We introduced GCP examinations and certification as early as 1996. We provide training combined with a test of knowledge – not just certification.
Our online courses are designed to provide good core training in GCP and uphold our principles of providing high quality at a cost effective price.COSTS
See our website for one off costs. Alternatively ask about our package prices for multiple users. There are really attractive costs for groups of participants. The larger the group, the better the price.
2
www.brookwoodtraining-online.netwww.brookwoodtraining-online.net
ESSENTIAL GCPA narrated online, on demand course available in 11 languages
Narrated in the chosen language … slide and sound presentations
Five interactive quizzes between sections
Final online multichoice exam for the ‘Certificate in Essential GCP’
Takes about one hour plus additional optional study
Progress reporting and tracking of individuals and groups
Ideal for core GCP training of sponsor teams as well as investigators
Available in English, French, German, LatAm Spanish, Brazilian Portuguese, Italian, Polish, Turkish, Chinese, Japanese, Russian
Safe and secure access using passwords
99%rated this as meeting
their needs
All language versions of this ICH E6 GCP investigator site training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors.
“I would rank this amongst the top general GCP modules around in terms of content, palatability, and knowledge checks. A course of high quality thank you.”
ICH GCP guidelinesINDEXED POCKETBOOK
Providers of online clinical research &
GCP training
3
www.brookwoodtraining-online.netwww.brookwoodtraining-online.net
90 to 100 questions in various formats, made interesting with the use of characters
Can be used as either initial or refresher training
No narration, can be done at a speed and pace to suit the user
Feedback given after submitting each answer
Tabs in player allow participant to study the key areas at any time
Takes up to one hour continuous training plus additional study time if the participant reads the tab interactions
An 80% pass mark set for certification. Can be repeated until a pass mark is attained
Participant can log on and off and do the training progressively
Progress reporting and tracking of individuals and groups
Safe and secure access using passwords
LEARN AND REFRESH GCP USING Q&AFully interactive courses with questions covering all aspects of GCP.
*This ICH E6 GCP investigator site training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors.
4
www.brookwoodtraining-online.netwww.brookwoodtraining-online.net
FOR INVESTIGATORS*
90+ questions check GCP knowledge in the key areas relating to GCP principles, investigator responsibilities and the Declaration of Helsinki.
FOR SPONSORS
This version teaches and refreshes both key investigator and sponsor GCP responsibilities, as well as the Declaration of Helsinki.
GCP REFRESHER
A shortened form with 50 Q&As testing the most important areas of GCP.
Ideal as a refresher for the more those with previous GCP training.
FOR ADMINISTRATORS
This version has a lower degree of difficulty and covers only the key areas of GCP that an administrator needs to know.
FOR SENIOR MANAGERS
This version provides high level GCP training and a refresher for senior managers.
5
www.brookwoodtraining-online.netwww.brookwoodtraining-online.net
LEARN & REFRESH UK CLINICAL TRIAL REGULATIONSDesigned for those who need to learn about and demonstrate their UK Clinical Trial Regulations knowledge. UK inspectors ask about ‘UK regs’ training!
Questions in various formats, made attractive with the use of characters
Can be used as either initial or refresher training
No narration, can be done at a speed and pace to suit the user
Feedback given after submitting each answer
Tabs in player allow participant to study the key areas at any time
Takes under one hour to complete the Q&A
An 80% pass mark set for certification. Can be repeated until a pass mark is attained
Participant can log on and off and do the training progressively
Progress reporting and tracking of individuals and groups
GOOD CLINICAL LABORATORY PRACTICE This 30 minute narrated course is based on the guidance given in the European Medicines Agency: “Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples”, adopted by the GCP Inspectors Working Group in 2012 1.
It is ideal for laboratory staff needing an insight into GCLP requirements as well as sponsors’ monitors, medical experts and auditors who utilise laboratory services in clinical trials
It covers the most important aspects in the Reflection Paper and offers practical advice on how and when a laboratory should comply
The programme also covers some GCP basics to fulfil the requirement that laboratory staff have relevant GCP knowledge
1. European Medicines Agency. GCP Inspectors Working Group. Reflection paper on guidance for laboratories that perform the analysis or evaluation of clinical trial samples. Document reference EMA/INS/GCP/532137/2010
Canary
The UK Clinical Trial Regulations
Indexed and Consolidated
Incorporating Statutory Instruments 2004 No. 1031,
2005 No. 2754, 2005 No. 2759, 2006 No. 1928, 2006 No. 2984, 2007 No. 289, 2008 No. 941,
2009 No. 1164, 2010 No. 1882
TH IRD ED I T ION
6
www.brookwoodtraining-online.netwww.brookwoodtraining-online.net
INVESTIGATOR OVERSIGHTAdequate oversight of trials and proper delegation of trial-related responsibilities is vital in every clinical trial. It is carefully checked by regulatory authority inspectors.
This 20 minute course is relevant to principal investigators, investigator study team members, study monitors, contract research organisations, auditors and inspectors.
This course presents information on
what are good and poor practices relating to delegation of study-related tasks by principal investigators
what is adequate oversight of studies by principal investigators
what makes up adequate training of study personnel
why adequate oversight is so important
A Q&A section with case studies will to help you to test knowledge on what is good and poor practice
GCP PROBLEM SOLVINGIdeal basic training or as a refresher for sponsors and investigators who need to learn about solving GCP problems using a root cause and CAPA method.
The 30 minute course is narrated, with interactions, and presents information on
using risk assessment to predict and minimise breaches of GCP and protocol violation
commonly observed breaches
identifying the root cause
corrective actions (CA)
preventative actions (PA)
using the CAPA approach to manage breaches and violations
a SMART way to write your audit and inspection responses
Study
Personnel
Log
7
top related