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Sets of 52 question and answer cards on a range of topics.
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ICH GCP Investigators' ResponsibilitiesISBN 978-1-903712-88-7 £9.99 per set (ex VAT) Perfect combination with our 12 Golden GCP Rules for Investigators book. |
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ICH GCP Sponsors' ResponsibilitiesISBN 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) Perfect combination with our ICH GCP Guidelines indexed pocketbook. |
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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. £9.99 per set (ex VAT)
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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. £9.99 per set (ex VAT) Buy Part 1 and Part 2 together .... £2 discount
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Best Practices for Phase I studiesISBN 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)
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FDA Regulations (Part 1): 21 CFR Parts 312 & 54ISBN 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. £9.99 per set (ex VAT) Buy FDA Regulations Part 1 and Part 2 together .... £2 discount
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FDA Regulations (Part 2): 21 CFR Part 50, 56 & investigator responsibilitiesISBN 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. £9.99 per set (ex VAT) Buy FDA Regulations Part 1 and Part 2 together .... £2 discount
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