Select an Author Barnard, J Bates, A D'Arcy, E Doyle, S Fagan, M Gray, S Hammond, J Hosken, J James, B Kermani, F Lai, Rene MacKintosh, A Nolan, C Pozniak, E Rea, M Robson, A Rod, M Wager, E Williams, D Wyse, R Select a Topic Clinical Research Drug Safety Management Skills Sales and Marketing Conference Insights Expert Reviews Improving Practices email address password  More Information  Activate  Forgotten Password  News  New Issue alert  Contact Us  Tell a Friend   You are here > questionnaire for FDAAA Legislation: Global Implications for Clinical Trial Reporting and Publication Planning FDAAA Legislation: Global Implications for Clinical Trial Reporting and Publication Planning This quiz has been prepared by Liz Wager, author of a KeywordPharma Expert review FDAAA Legislation: Global Implications for Clinical Trial Reporting and Publication Planning, which describes the new requirements for trial registration and the reporting of results, and explains what companies need to do now. Q.1 FDAAA stands for A.1 The FDA Advertising Act A.2 The FDA Modernisation Act A.3 The FDA Amendments Act A.4 Federal Drug Administration Authority Act Q.2 FDAAA A.1 doesn't apply to trials in Europe A.2 applies to Phase II to IV trials of applicable products A.3 only applies to Phase I trials A.4 doesn't apply to medical devices Q.3 FDAAA will require details of adverse events in applicable trials to be posted A.1 from 2009 A.2 never A.3 from September 2008 A.4 if the sponsor wants to do this Q.4 Results summaries posted on clinical trials.gov A.1 will not prevent publication in a journal A.2 will prevent publication in a journal A.3 will replace abstracts at meetings A.4 will not be available to the public Q.5 clinicaltrials.gov A.1 is the only register recognised by ICMJE (journal editors) A.2 only accepts US trials A.3 only accepts NIH funded studies A.4 is the only register recognised by FDAAA Q.6 FDAAA means that A.1 all trials on applicable products must be published in journals A.2 Phase II-IV trials on applicable products must be registered A.3 all US trials must be registered A.4 Phase I trials on applicable products cannot be registered Q.7 Results summaries for lay people should be posted on clinicaltrials.gov A.1 from 2010 (so long as they are not promotional) A.2 as soon as possible A.3 for all trials currently registered on clinicaltrials.gov A.4 within 30 days of the end of the trial Q.8 Members of the International Committee of Medical Journal Editors (ICMJE) A.1 oppose trial registration A.2 require trial results to be posted before publication in a journal A.3 will only allow results to be posted after publication in a journal A.4 may refuse to publish results that have been posted on company websites Q.9 If the FDA rejects a licensing application for a new product A.1 results of relevant trials do not have to be posted on clinicaltrials.gov A.2 results of relevant trials cannot be posted on clinicaltrials.gov A.3 results of relevant trials still have to be posted on clinicaltrials.gov A.4 results of relevant trials should be posted on the sponsor's website Q.10 Phase II-IV studies of drugs licensed for treatment in the US A.1 must be registered on clinicaltrials.gov within 12 months of the 1st patient enrollment A.2 must be registered on clinicaltrials.gov within 21 days of the 1st patient enrollment A.3 must be registered on clinicaltrials.gov within 12 months of the study end A.4 must be registered on clinical trials.gov as soon as possible The International Publication Planning Associations 2010 Midwest Meeting: tackling the authorship debate in publication planning written by Clare Nolan Free sample pages (1.28MB) 0 item in your cart Change Currency US Dollars British Pounds Euro All transactions conducted independently by WorldPay   Managed by NetworkPharma © Copyright 2010 NetworkPharma Ltd Other services managed by NetworkPharma [www.europeanCMEforum.eu] [www.MedCommsNetworking.co.uk] [www.ThePharmYard.com] [www.ThePublicationPlan.com] Site design Swimming Hippo Digital