get started with eudract to prepare and post results
DESCRIPTION
Get started with EudraCT to prepare and post results. Noémie Manent Compliance and Inspection. Agenda. Introduction How to register How to become a results user How to request trial assignment Manage users Q&A. Introduction. Launch of EudraCT V9 in October 2013 and V10 in May 2014: - PowerPoint PPT PresentationTRANSCRIPT
An agency of the European Union
Get started with EudraCT to prepare and post results
Noémie ManentCompliance and Inspection
Agenda
• Introduction
• How to register
• How to become a results user
• How to request trial assignment
• Manage users
• Q&A
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Introduction• Launch of EudraCT V9 in October 2013 and V10 in
May 2014: – initial step of a process through which summary clinical trial
results will be made publicly available through the EU Clinical Trials Register (EU CTR)
• Clinical-trial sponsors can register on the EudraCT website to start uploading summary results
• Guidance on posting and publication of result-related information on clinical trials in relation to the implementation http://ec.europa.eu/health/files/eudralex/vol-10/2012_302-03/2012_302-03_en.pdf
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How to register
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How to register• https://eudract.ema.europa.eu/
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Register for a EudraCT Account
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Agreement with data protection statement
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Enter personal details
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Registration
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Registration
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Registration
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Registration
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How to become a results user
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How to become a results user
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How to become a results user
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How to become a results user
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How to become a results user
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How to become a results user
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How to request trial assignment
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How to request Trial Assignment20
Log in EudraCT
Request Assignment
How to request Trial Assignment21
Step 1: Identify trial (up to 50)
How to request Trial Assignment22
Step 2: select the request method
Presentation title (to edit, click View > Header and Footer)23
Step2A: Requested method: via a letter from the sponsor
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Step2A: Requested method: via a letter from the sponsor - Enter trial details
How to request Trial Assignment25
Step2A: Requested method: via a letter from the sponsor - Attach letter
How to request Trial Assignment26
Step2A: Requested method: via a letter from the sponsor - Attach letter
How to request trial assignment27
Step2A: Requested method: via a letter from the sponsor - Attach letter
How to request Trial Assignment28
Step2A: Requested method: via a letter from the sponsor - Attach letter
How to request Trial Assignment29
Step2A: Requested method: via a letter from the sponsor - Request assignment – screen confirmation
How to request Trial Assignment30
Step2A: Requested method: via a letter from the sponsor - processing
How to request Trial Assignment31
Step2A: Requested method: via a letter from the sponsor - End of process
How to request Trial Assignment32
Step2A: Requested method: via a letter from the sponsor - Once the request is approved
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Step2B: Requested method: based on protocol information
• A user, for whom the email address was included in the CTA submitted to the national competent authority, can request the trial assignment by selecting the option “request assignment based on protocol information”.
• This request will be automatically granted if the email address of the requestor/user matches the one included in the CTA.
• This method is fast and effective and if there is a match between the email addresses, the requestor has immediate access to the result user interface for the trial.
Presentation title (to edit, click View > Header and Footer)34
Step2B: Requested method: based on protocol information
The following CTA fields are verified against the requestor email during this process:
B.1.6 Sponsor Contact email
B.2.6 Legal Representative email
C.1.4.6 Request for the competent authority email
C.2.5.6 Request for the ethics committee email
Presentation title (to edit, click View > Header and Footer)35
Step2A: Requested method: via a letter from the sponsor - Request assignment – screen confirmation
How to request Trial Assignment36
Step2B: Requested method: based on protocol information – click confirm
Presentation title (to edit, click View > Header and Footer)37
Step2B: Requested method: based on protocol information – outcome of assignment request
Presentation title (to edit, click View > Header and Footer)38
Step2B: Requested method: based on protocol information–end of process return to your page
Presentation title (to edit, click View > Header and Footer)39
Manage users
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Manage users
- Done at the trial level - Performed by the sponsor via the primary user- The primary user assigns other users (who are results users) to a trial- The other roles are:
- Primary user back up- Preparer and poster- Preparer
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Q&A
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