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L&R cards ICH GCP Investigators' Responsibilities
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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.
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L&R cards ICH GCP Sponsors' Responsibilities
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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.
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L&R cards FDA Regulations (Part 1)
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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.
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L&R cards FDA Regulations (Part 2)
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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.
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L&R cards UK Clinical Trial Regulations (Part 1)
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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.
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.
Two part set
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L&R cards UK Clinical Trial Regulations (Part 2)
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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.
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.
Contact us directly for large orders and discounts on sets.
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L&R cards Best practices for Phase I studies
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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.
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