brookwood’s online gcp training solutions€¦ · essential gcp a narrated online, on demand...

Brookwood’s online GCP

training solutions

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:

[email protected]

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.

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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

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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


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.

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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.

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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


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

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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

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5 Studley Court Mews, Chobham, Surrey GU24 8EB Tel: +44 1483 811383 Fax: +44 1483 812163

[email protected] www.brookwoodacademy.org

www.brookwoodtraining-online.net

Artwork: LIMA Graphics, Guildford, Surrey, UK

brookwood’s online gcp training solutions€¦ · essential gcp a narrated online, on demand...

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