Results of Clinical Trials in EudraCT Sponsor meeting 16 January 2012

Results of Clinical Trials in EudraCT This meeting is a brainstorming on possible approaches. This is an interactive session and we should all actively participate by providing inputs, thoughts on the approaches. We are addressing technical implementation and we are not reviewing the regulatory requirements or guidance.

Agenda Background and Project Update Interactive discussion on user account and log in including Registration Security and authentication User account management including identification of roles (preparation, posting and delegation) Preparation for results and posting A.O.B 2

Background and Project Update

Background & Project Update Implementing Technical guidance of the commission: “…List of fields for result-related information to be POSTED to the 'EudraCT' clinical trials database, and to be made public, in accordance with Article 57(2) of Regulation (EC) No 726/2004 and article 41 of regulation (ec) no 1901/2006 and their implementing guidelines 2008/C168/02 and 2009/C28/01…” To support reporting of Clinical Trial Results in EudraCT, EMA to introduce Sponsor Login to EudraCT to post Results (as described in draft Results guidance) 4

Background & Project Update Draft workflows being prepared, key points: Individuals will be able to register in EudraCT and be provided with a user account (user Id/password) Individuals must be “fully” registered to prepare & post results for a CTA with: Authentication to be defined Delegation of role to be defined

Background & Project Update Delivering Results functionality through 2012 Harmonise with US clinicaltrials.gov and international standards Sponsors will need to be registered in EudraCT to Post Results Preparation and Posting of Results by Sponsors in EudraCT Auto-population of some Results fields from CT protocol data Technical validation of Results data in EudraCT Publication of Results in EU Clinical Trials Register Notifications to NCAs when Results posted Planning for extensive prototyping & piloting before go-live 6

Definitions Prepare results: actions of entering data within EudraCT - responsibility of the sponsor Post results: action that request results to be published in the EU CTR -responsibility of the sponsor Publish results: action of making results publicly available in the EU CTR

Context Diagram

High Level Plan EudraCT 9 2012 2013 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Post Results Prototyping Develop & Test Pilot & Feedback Publication of Results Prototyping Develop & Test Pilot & Feedback 9

Description of Process

Step 1: Registration – Option for ‘simple’ registration Goal – To create a user account that is not yet associated with a role/permissions

Step 2: Security and Authentication “take ownership for clinical trial results” How to assign the roles of preparing and posting results in EudraCT for a particular clinical trial? Define an authentication process: Goal – To assign the role of preparing and posting results for a particular clinical trial

Step 2: Security and Authentication Scenario 1: the registered user was a contact person on one of the CTAs (identical name and email address) Scenario 2: the registered user is a PIP addressee and is a contact person in the Paediatric Database (PedRA) (identical name and email address) Scenario 3: unknown individual in the context of CTAs linked to a EudraCT number

Step 3: Delegate The user that has been “authenticated” can delegate the role of preparing and posting results for a particular clinical trial

Step 4: Prepare and post results Responsibility: the user who has been authenticated or delegated the roles

Identify Sponsor A necessary step will be to identify the Sponsor linked with the EudraCT number before posting results. We could consider to have in the system a register of known Sponsors, i.e. company and address.