Future Training Programme SME info day: The new clinical trial regulation, 20 March 2017 Presented by: Ana Rodriguez, Head Clinical and Non-clinical Compliance An agency of the European Union
Training purpose • Training plays a critical role in providing stakeholders with the skills, capabilities and knowledge needed to implement the changes required for a successful transformation and adoption of the new ways of working. • A programme training strategy has been developed for the Clinical Trial programme which provides an overview of how training needs have been analysed and how training will be designed, developed, delivered and evaluated. • Training will be delivered in line with a training framework: EU P&DB system training - content delivery plan 1
Training fram ew ork The training framework sets out the steps through which training requirements are defined and material is designed, delivered and evaluated. Design & Analyse Deliver Evaluate Develop • Analyse the gaps • Deliver e ffective • Build tailored, focused • Measure between the skills, training and user-friendly training • Enable all knowledge, training content to effectiveness impacted users to capability and bridge the identified behaviours of adopt new w ays skills, knowledge, • Identify of w orking . system users today capability and behaviour additional • Establish a Super and requirements of gaps training needs User netw ork for them in the future • Prepare for training and areas for state. ongoing support deployment improvement to post Go Live • Assess existing factor in the infrastructure to next training support training roll-outs efforts 2
Training fram ew ork Outputs • Training needs assessment • Training channel assessment Analyse • Detailed plan for Design & Develop stage • High level plan for Deliver and Evaluate stages Outputs • Training templates Design & • Training material • Detailed plan for Deliver and Evaluate stages Develop Outputs • Trained end users Deliver Outputs • Updated training material where required • Lessons learned for training material development for Evaluate future programmes 3
Guiding principles The following guiding principles underpin the Clinical Trial Programme training. Not m andatory for users to com plete training prior to accessing the system 1 Training m aterial should be developed and dissem inated in a w ay to enable 2 sponsor users to subm it a Clinical Trial Application w ithin 1 w orking day Existing EMA capabilities and facilities including current query m anagem ent 3 system s to be utilised w here possible Training m aterial tem plates should w here possible be consistent w ith other Agency program m es to ensure that external stakeholder receive a 4 consistent training experience Training to be supplem ented w ith robust, ongoing online support and 5 query m anagem ent Opportunities and budget for Face – to – Face training is lim ited and 6 therefore should be targeted at key processes. 4
Targeted Audience EC EMA MA Applicant Public Member States Sponsors NCAs and Ethics Committees Secure Access Open Access Public DB CT DB
Training Needs Assessm ent- Outcom e • Understand the impact of the CT regulation implementation on the different stakeholders groups • Conducted a survey to identify training requirements • Overview of the training modules identified Training content Audience to be targeted Module Module Title Module Description Ref CTTM0 1 I ntroduction to the • Overview of the Regulation • Member States Clinical Trial Regulation • Sponsors • Explanation of key changes from the Directive • EMA 2001/ 20/ EC • Public • Overview of the transition period CTTM0 2 I ntroducing the EU • Overview of the functionality available to Public Users • Public Portal and Database for • Guides on how to search and download data and the Public Users pre-defined reports on Clinical Trial information CTTM0 3 I ntroducing the EU • Overview of the core functionality available to • Member States Portal and Database for Registered Users • Sponsors Registered Users • EMA • Overview of the different roles which can be assigned to Users and the functionality that each of these roles provides CTTM0 4 Managing Registered • Guides on how to assign a role/ clinical trial access to • Administrators Users a registered user affiliated to an organisation • Guides on how to amend/ revoke the roles/ CT access assigned to a user 6
Training Needs Assessm ent- Outcom e Training content Audience to be targeted Module Module Title Module Description Ref CTTM0 5 Creating and • Overview on how to prepare and submit a • Sponsors subm itting a Clinical Clinical Trial Application Trial Application • Introduction to the Assessment process and associated timelines CTTM0 6 Managing a Clinical • Overview of the Sponsors reporting • Sponsors Trial through the EU responsibilities throughout the Clinical Trial • MAH Portal and Database lifecycle (Request for information, notifications, withdrawals etc.) • Overview of the functionality available to Sponsors to manage a Clinical Trial through the EU Portal and Database CTTM0 7 Assessing a Clinical • Overview of the stages and associated • Member States Trial Application timelines for assessing a Clinical Trial Application • Overview of the functionality available to Member States to assess a Clinical Trial Application CTTM0 8 Supervising a Clinical • Overview of how Clinical Trials are supervised • Member States Trial through the EU including initiation of corrective measures Portal and Database (revoke , suspend or modify the trial) and the available functionality CTTM0 9 Supervising- Creating • Overview of how to exchange inspection plans • MS Inspectors I nspection Records in and prepare and submit inspection reports the EU Portal and and the available functionality Database 7
Training Needs Assessm ent- Outcom e Training content Audience to be targeted Module Module Title Module Description Ref CTTM1 0 Managing publishing • Remove data that contains commercially confidentially • EMA confidential information or personal data from public Administrators view • Publish CT data when there is an overriding public interest • Leave a public comment on a clinical trial CTTM1 1 Managing Union • Overview on how to create and submit a union control • European controls plan report as well as the submission of Union controls Commission and the functionality available in the system to facilitate this 8
Training channel assessm ent- Outcom e Channel Sum m ary of scope • User Manual • Full and comprehensive system guide – addresses happy and all alternate paths • To understand the • MS Word or pdf document potential means by • Addresses discrete functionality or topic • Overview video • Level of detail varies by video type which training • Presented in an online MS PowerPoint presentation with voice over material can be • Step by step process • Videos in similar format to UAT videos, produced using the video “Snag It” tool disseminated • Process overview • Quick guide • 1-2 page A4 MS Word or pdf document including screenshots of key steps. • Typically only covers the happy path • I n-system help • Short “pop up” explanation of fundamental items • Templates to provide guidance on when tool tips should be provided in the system including length and purpose • Content to be derived from user manual Online presentation • Detailed walk-through of functionality • • Addresses happy path, and commonly-used alternate paths • MS PowerPoint presentation with no voice over/ video W ebinar • • Interactive delivery of the material within online PowerPoint presentation • Face-to-face training • Split by stakeholder group i.e. Sponsors/ Member States
Training approach Online Training On-going Face - to - face training colleagues support Details Details Details Details • Lead trainers use • The EMA provides • Enable submission of • Tailored training of dossier in 1 day Lead trainers knowledge and online on- going support material to train • Online material: • Provided by training through Webinars, colleagues concessionaire - demo videos, Query • Online material (refer - test environment, • 2-3 days for management, etc. to the Online training - user manuals, commercial sponsors section) - guidance documents • 1 day for SME’s & - in-system information non-commercial sponsors Targeted at: Targeted at: Targeted at: Targeted at: • Member States • Member States • All stakeholders • All stakeholders • Large commercial • Large commercial sponsors sponsors • SME’s • SME’s • Non-commercial • Non-commercial sponsors sponsors Primary focus of training
EUPD m axim um project tim elines: Training Plan 11
Thank you for your attention Further information Ana Rodriguez Ana.rodriguez@ema.europa.eu European Medicines Agency 30 Churchill Place • Canary Wharf • London E14 5EU • United Kingdom Telephone + 44 (0)20 3660 8449 Facsim ile + 44 (0)20 3660 5555 Send a question via our w ebsite www.ema.europa.eu/ contact Follow us on @EMA_ New s
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