1. Results of Clinical Trials in EudraCT Sponsor meeting
16 January 2012

2. 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.

3. 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

4. Background and Project Update

5. 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

6. 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

7. 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

8. 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

9. Context Diagram

10. 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

11. Description of Process

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

13. 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

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

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

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

17. 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.