Notification of studies - Survey results - June 2021 - Sorina Puiu Transformation Services Unit - EFSA
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08/06/2021
Notification of studies –
Survey results – June 2021
Sorina Puiu
Transformation Services Unit
Type of Organisations Answering the Survey
Business Operator 6
27%
Laboratory 2 55%
3rd Party operating on behalf of business operators 3
3rd Party operating on behalf of laboratories 0
National competent authority (MS) 0
18%
Anonymous survey
Total participants: 9
2Most Appreciated Aspects of Notification of Study
Database (1/2)
3rd Party
Business
Laboratory on behalf Comment
Operator
of BO
The panel on the right which explains mandatory fields
X
when doing a notification
X The info-fields that can be clicked on for additional help
Pre-filling fields and drop-down menus intended to
X
make choices easier
General layout gives a good overview, mandatory fields
X
easy to find
X All-in-all, a workable platform
X X Concept is good
X X Some areas easy to use
3Most Appreciated Aspects of Notification of Study
Database (2/2)
3rd Party
Business
Laboratory on behalf Comment
Operator
of BO
Use of system seems to be getting smoother with users
X
gaining experience in the system
X Flexibility for assigning business operator
X User friendly
X Very intuitive and self-explanatory
The recommendations on the right side of the screen for
X
each section
X The possibility to track down public consultations
X Receiving emails about public consultations open
4Less Appreciated Aspects of Notification of Study
Database (1/3)
Areas of
Comment
improvement
Communicate in advance to users:
Change
• What will change
Management
• When changes are planned
• Selection of Laboratories (legal entity) or Internal testing facilities
• Create relationship with 3rd parties
Clarity
• Information in the notification emails (in case notified lab and mail
address do not match)
• Automatic data upload
• Reject notifications from the co-notifier
• ‘Unlink' study notification from pre-application IDs, if a study notification is
added in error to a pre-application ID
Missing features
• Remove draft notifications
• Organisation structure in account registration (headquarters, departments)
• Change laboratory in notified study
• Missing study id or pre-application id in email alerts
5Less Appreciated Aspects of Notification of Study
Database (2/3)
Areas of
Comment
improvement
• Field Size definitions
Information • Pick List contents
elements • Missing items from drop-down menus (e.g., EFSA guidance, or "Purity"
under Study Types)
• 3 users per company account is too few, even with less than 50
Licenses
notifications per month
Registration • Issues with validation of accounts and contacts
Test environment • Availability of a test environment to allow users to practice
6Less Appreciated Aspects of Notification of Study
Database (3/3)
Areas of
Comment
improvement
• Drop-down menu study type includes too many options
• Option "go back to the previous page" on the browser
• Mark a study as "in-house" after notification
Usability • Limited dropdown for labs
• Look up if a laboratory is already available to choose or not
• Manual entries of unregistered laboratories are not saved in the system for
future use
7Top Suggestions for Enhancement (1/2)
Areas of
Comment
improvement
• Inform users on the changes planned to be made to the database/new
Change
requirements before
Management
• Clear development roadmap and change log for the IT tools from EFSA
• Automatic data upload
• "Export" function via excel
• Changes made before "submission" should not be traced (it’s confusing)
• Create "reject notification" option
• Include Business Operator information (contact person and e-mail
address) in the notification e-mails
• Improve search in dropdown Lists
Enhancements
• Allow draft notifications to be removed without consequence.
• Draft notifications should not be visible by the performing laboratories
before being submitted
• Allow study notification to be removed from pre-application IDs, when
added by error
• Overview tables of studies and pre-application IDs
8Top Suggestions for Enhancement (2/3)
Areas of
Comment
improvement
• Extend the number of characters in several fields (study title, study
Information
internal code...)
elements
• Publishing of Pick List values
Licenses • Increase number of users (contacts) per organization (account)
Registration • Reduce time for accounts and contacts validation
Test environment • Availability of a test environment to allow users to practice
9Top Suggestions for Enhancement (3/3)
Areas of
Comment
improvement
• Improve the user interface to show notification status
• Simplify the selection options for submitting a notification of a study
• Remove fields that do not apply to renewal of authorisations from sections
Usability
that do not correspond to renewals
• Improve drop down menus & divide into REPRO areas (food, feed,
pesticides...)
10Satisfaction Level for the Support
22.2% 33.3%
11.1% 33.3%
Anonymous survey
Total participants: 9
11Opportunities for Improving the Support (1/2)
Business Laboratory 3rd Party on Comment
Operator behalf of BO
A technical support function where quick responses can be obtained as well as a
X training environment would be crucial features to improve the support for this
database
It may also be a good idea to hold another webinar or Q&A session with any
questions that are still coming up and have come up since EFSA published the Q&A
X
document on the practical arrangements to follow up on the learnings from the
first few months of actual use of the Notification platform
Overall, I would like to mention that I appreciate EFSA's efforts to support
applicants by way of Webinars and the Q&A document as well by making the forms
in the Notification platform quite easy to fill. It is an unfortunate - both for
X
applicants and EFSA - that there was relatively little time for implementation of the
Notification platform, which left, e.g., no time for actual users to test or possibility
to point out technical issues before implementation of the transparency regulation
X EFSA could solve IT issues/provide support within days
The person in charge of solving the issue could send email to the "client" explaining
X
that the issue was solved and requesting feedback through a direct email
Publish an enhancement request/management process, so common requests by
X X
multiple parties can be identified and prioritization of requests is enabled
12Opportunities for Improving the Support (2/2)
Business Laboratory 3rd Party on Comment
Operator behalf of BO
Initial support was very fast and helpful. Since then, support answers have slowed
X
down and some questions are still unanswered
X X Faster response to problems & questions
X X Install interactive training & practise area for NoS (& dossier submissions)
X X Provide EFSA templates for dossier sections
It would be beneficial to keep a live version of the FAQ which was published at the
X end of March 2021, to reflect any changes in the guidance, or clarifications which
may come to light through use of the system over time
X Increase opportunities for explain the technical issues
A lot of support was already provided.
X Increased interaction with applicants and their representatives (real target of new
rules and EFSA new tools) should take place
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