Version 10.0 14 August 2014 Member GCP Training Solutions Meeting the Minimum Criteria Company Meets Minimum Criteria Version(s)/Date(s) AbbVie v06 June 2014 AbbVie v04 April 2013 AstraZeneca v1.1 7Feb 2013 AstraZeneca v1.1 7Feb 2013 Boehringer Ingelheim v1.1 7Feb 2013 Boehringer Ingelheim v1.1 7Feb 2013 BMS does not currently provide GCP trainingInvestigator's responsibility when signing the 1572 and Bristol-Myers Squibb only provides study-specific training, byut will accept other TransCelerate members GCP training Certificates Version Number/Date Training Effective Date V06 6-Jun-14 V04 5-April-2013 Rolled Out 2 5-April-2013 Rolled Out 2 29-Aug-2013 Rolled Out V global 2.0 13 Nov 2013 Rolled Out V global 2.1 N/A N/A N/A 13-Aug-2013 Rolled Out N/A 16-May-2013 Rolled Out Title of Training Good Clinical Practice for Clinical Investigators and Trial Sites (online) Good Clinical Practice for Clinical Investigators and Trial Sites (F2F) International Conference on Harmonisation E6 Good Clinical Practice (ICH GCP) Investigators Training - Presentation International Conference on Harmonisation E6 Good Clinical Practice (ICH GCP) Investigators Training - E-Learning GCP for Investigators & Site Staff (superseded but any V2.0 certs issued are acceptable) GCP for Investigators & Site Staff Bristol Myers Squibb V1.1 7Feb 2013 Note *BMS does not provide GCP training but will accept TransCelerate certification Eli Lilly v1.1 7Feb 2013 ICH E6 GCP Investigator Training - E- v1.0 May 2013 and Learning v1.1 March 2014 Eli Lilly v1.1 7Feb 2013 ICH E6 GCP Investigator Training Presentation v1.0 May 2013 and v1.1 March 2014 12-Aug-2013 Rolled Out Forest v1.1 7Feb 2013 ICH GCP Investigator Training 1 13-July-2013 Rolled Out 16-May-2013 Rolled Out Version 10.0 14 August 2014 Member GCP Training Solutions Meeting the Minimum Criteria Meets Minimum Criteria Version(s)/Date(s) Title of Training Version Number/Date Training Effective Date GlaxoSmithKline v1.1 7Feb 2013 “GCP & The Investigator Responsibilities – Standard Slides” version Aug 2013 E-Learning Good Clinical Practice Investigator Responsibilities_Aug 2013 Standard Slides August 2013 E-Learning Aug 2013 April 10, 2014 GlaxoSmithKline Yes/Version 2 April 10, 2014 Janssen v1.1 7 Feb 13 Pfizer v1.1 7Feb 2013 Roche v1.1 7 Feb 13 Company Roche Roche Sanofi Version 3, February 18, 2014 Version 3, February 18, 2014 v1.1 7Feb 2013 As of Jan 2010 for paper based; as of GCP Presentation 2 12/22/2010 for eLearning Good Clinical Practice (GCP) and Best 28-June-2013 Practices when managing clinical trials, Rolled Out Date ver. Jan 2010 ver. Jan 2010 of Acceptance 01 Jul 2013 Good Clinical Practice for 1-July-2013 Rolled v2.0 / 28June2013 Investigational Site Staff Out Good Clinical Practice (Investigator v 1.0 Version) Buenas Practicas en Investigacion V3 Clinica - Multi-módulo en línea Buenas Practicas en Investigacion 1st Aug.’13 vs 1st V3 Clinica - Multi-módulo presencial Sept. ‘13 Essential GCP on-line training 1
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