Learn & Refresh Q & A Card Sets

Sets of 52 question and answer cards on a range of topics.
Suitable for members of the study site, academic units and universities, monitors, auditors, members
of ethics committees and trainers.

These cards are easy to carry around and provide an ideal way to learn a subject or refresh and test your knowledge when on the train, plane or just having a coffee ....
Great as a competitive team game ....perfect for training sessions
Investigator topics can help facilitate compliance at study site.


Scroll down for more details of .....

  • ICH GCP Investigators' Responsibilities
  • ICH GCP Sponsors'  Responsibilities
  • UK Clinical Trial Regulations (Part 1)
  • UK Clinical Trial Regulations (Part 2)
  • Best Practices for Phase I studies
  • FDA Regulations (Part 1)
  • FDA Regulations (Part 2)


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    Sample cards

ICH GCP Investigators' Responsibilities

ISBN 978-1-903712-88-7

A set of 52 cards containing questions and answers about the responsibilities of investigators conducting trials in accordance with ICH GCP. Ideal for all members of the study site, as well as monitors, auditors and ethics committee members.

£9.99 per set (ex VAT)
Ask about discounts for orders of 50 sets or more.

Perfect combination with our 12 Golden GCP Rules for Investigators book.

 

ICH GCP Sponsors'  Responsibilities

ISBN 978-1-903712-89-4

A set of 52 cards containing questions and answers about the responsibilities of sponsors conducting trials in accordance with ICH GCP. Ideal for all sponsor teams, academic units and investigator-sponsors.

£9.99 per set (ex VAT)
Ask about discounts for orders of 50 sets or more.

Perfect combination with our ICH GCP Guidelines indexed pocketbook.

 

UK Clinical Trial Regulations (Part 1)

ISBN 978-1-903712-90-0

A set of 52 cards containing questions and answers about the UK Clinical Trial Regulations. Based on Statutory Instrument SI No. 1031 of  2004 and all subsequent amendments to 2010.
Ideal for anyone involved in clinical trials in humans on medicinal products in the UK.
This set focuses on the regulations. A complementary set (Part 2) with even more questions is also available.

£9.99 per set (ex VAT)
Ask about discounts for orders of 50 sets or more.

Buy Part 1 and Part 2 together .... £2 discount
Perfect combination with our UK Clinical Trial Regulations, Indexed & Consolidated book

 

 

UK Clinical Trial Regulations (Part 2)

ISBN 978-1-903712-91-7

A set of 52 cards containing questions and answers about the UK Clinical Trial Regulations. Based on Statutory Instrument SI No. 1031 of  2004 and all subsequent amendments to 2010.
Ideal for anyone involved in clinical trials in humans on medicinal products in the UK.
This set focuses on the Schedules and guidance on reporting serious breaches (October 2010).
 A complementary set (Part 1) provides even more questions.

£9.99 per set (ex VAT)
Ask about discounts for orders of 50 sets or more.

Buy Part 1 and Part 2 together .... £2 discount

Perfect combination with our UK Clinical Trial Regulations, Indexed & Consolidated book

 

 

Best Practices for Phase I studies

ISBN 978-1-903712-95-5

A set of 52 cards containing questions and answers about best practices relating to the conduct of Phase I studies. The questions are based on “Guidelines for Phase I Trials”, Association of the British Pharmaceutical Industry (ABPI), September 2007 and European Medicines Agency 2007 “Guideline on Strategies to Identify and Mitigate Risks For First-in-human Clinical Trials with Investigational Medicinal Products” (EMEA/CHMP/SWP/28367/07).

Ideal for all members of a Phase I unit, as well as monitors, auditors and ethics committee members.

£9.99 per set (ex VAT)
Ask about discounts for orders of 50 sets or more.

 

 

FDA Regulations (Part 1): 21 CFR Parts 312 & 54

ISBN 978-1-903712-92-4

A set of 52 cards containing questions and answers about the FDA Investigational New Drug Regulations and financial disclosure requirements. The questions are based on 21 CFR Part 312 and Part 54, current on the FDA website in February 2011.
Ideal for anyone needing to learn or brush up their skills on the IND regulations.
 A complementary set (Part 2) provides even more questions.

£9.99 per set (ex VAT)
Ask about discounts for orders of 50 sets or more.

Buy FDA Regulations Part 1 and Part 2 together .... £2 discount

Perfect combination with our 15 Golden IND/GCP Rules for Investigators book.

 

 

FDA Regulations (Part 2): 21 CFR Part 50, 56 & investigator responsibilities

ISBN 978-1-903712-99-3

A set of 52 cards containing questions and answers about the FDA  Regulations relating to consent and ethics, investigator responsibilities and Form FDA 1572. The questions are based on 21 CFR Parts 50 and 56 (current on the FDA website May 2011, FDA Guidance on Investigator Responsibilities (October 2009) and FDA Guidance on Form FDA 1572 (May 2010).

Ideal for anyone needing to learn or brush up their skills on the FDA regulations.
 A complementary set (Part 1) provides even more questions.

£9.99 per set (ex VAT)
Ask about discounts for orders of 50 sets or more.

Buy FDA Regulations Part 1 and Part 2 together .... £2 discount

Perfect combination with our 15 Golden IND/GCP Rules for Investigators book.

 

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