ESUSAR Website Guide Uk E SUSAR User
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eSUSAR Online Reporting
A Quick Guide
A Quick Guide to the eSUSAR Website
Introduction
The eSUSAR website is a reporting tool that enables clinical trial sponsors and other
institutions responsible for safety reporting to electronically report Suspected Unexpected
Serious Adverse Reactions (SUSARs) that are relevant to ensuring the safety of the UK clinical
trial population, to the MHRA.
This includes;
•
•
SUSARs occurring in the UK
Global SUSARs occurring where the sponsor for that trial also has a UK trial involving
the same IMP.
The eSUSAR website provides a free and fast registration process without the need to
complete a testing phase which is favoured by other reporting tools such as the Eudravigilance
Gateway or EVWEB.
In order to prevent duplicate reporting, only UK and third country (defined as being countries
outside the European Economic Area (EEA)) SUSAR reports submitted through the eSUSAR
website are forwarded to the European Medicines Agency’s Eudravigilance Clinical Trial
Module (EMA’s EVCTM).
SUSARS occurring outside the UK but within the EEA can be reported to the MHRA using the
eSUSAR website, but sponsors must also notify the relevant National Competent Authority
(who is responsible for ensuring the report is received by the EVCTM).
The eSUSAR website consists of 4 sections:
•
•
•
•
Home
About
Reports
Accounts
Home
Users are prompted to input their login details that were provided in the automated
acknowledgement email following institution registration or from the activation of a user
account by the Administrator. Users are required to reset their password immediately following
their initial successful login.
About
This page provides further information on the eSUSAR form.
Report
The report page guides the user through the process of completing the sections of the online
report for active trials with which they are associated. There is also a quick link to the online
report available in the Account page within the user’s recent reports as well as on the home
page. Please note, reports can only be entered for trials that have been created and registered
as active. Likewise, reports can only be created for trials that the user is associated with.
Account
The Account page is displayed as soon as the user logs into their account. This page lists
users own reports as well as those of other users of the same Institution; these reports are
only visible and accessible to the user if they are associated with that trial. Users also have the
option of managing and reviewing created reports. Only Administrators can view all reports for
all of their institution’s trials and also have additional features to create and manage member
accounts as well as create and manage trials.
Users can revisit the Accounts page at any time by clicking on the welcome link on the top
right hand corner.
Getting Started
Managing Users
• Registering as the administrator of an institution
Sponsors can apply to have an eSUSAR account by registering their Institution using the
relevant form found on the Safety Reporting pages of the MHRA website and allocating
staff with administrative rights for reporting.
This form should be emailed to esusar@mhra.gsi.gov.uk where the registration process should
take 2 working days to complete. An acknowledgement email will be sent to the new user with
their login details; a temporary password will be provided by the eSUSAR administrator
however, the new user will be prompted to change this password upon initial login following
registration.
• Registering new users
Only Administrators have the ability to create profiles for new users to the Institution
Account. To create a new user profile, Administrators should go to the Members section
within the Account page where all users of the Institute are listed. Administrators should
then click on the Add a member link and fill in the member form with the relevant
information. The View all members link takes users to the Manage Members page where all
members of the institution are listed. There is also another Add a member link on this page.
There is no limit to the number of users that can be added for each Institution.
It is advised that more than one user is given administrative rights to the Institution Account to
avoid issues with accessing the eSUSAR website in the possible event of an existing
Administrator becoming unavailable (for example sickness, annual leave). The member form
allows the Administrator to mark new users as either an Institution Member or an Institution
Administrator. Please note, Administrators cannot make changes to another Administrator’s
account unless they initially created that account.
• Unregistering users
All new and existing users are marked as Active in order to access the website. In the event
that a user needs to be unregistered from that Institution Account (for example if the user
leaves the institution), the Administrator can select the user from the list of Members on the
Manage Members page and click on the Edit icon to change their status.
• Editing user accounts
Administrators can edit the details of existing active users listed in the Manage Members
page. Users are also free to make changes to their own profile accounts such as marital
status, name changes and contact details.
Managing Trials
• Creating and registering a trial
All clinical trials associated with the Institution are listed in the Trials section within the
Accounts page. From here, Administrators can add a new active trial by clicking on the icon
Add a new trial. This should take the Administrator to the relevant form where all fields
should be filled. By clicking on the Add Trial icon the clinical trial is then registered with the
Institution.
It is recommended that, as soon as the sponsor receives MHRA approval for a clinical trial,
the trial is created by the Institution Administrator in order to avoid delays at the time of
submitting the first SUSAR report. It should be noted that trials must be flagged as active
for SUSAR reports to be submitted.
• Associating users to a trial
Administrators are able to associate existing users for reporting SUSARs to each clinical
trial upon registering a trial. To associate new users to a trial, administrators should click on
the Edit icon next to the relevant active trial where the new user’s name will then appear
listed to be selected.
• Unregistering a trial
A trial must be classed as active upon registering onto the Institute Account. Once a trial
has ended, the administrator can edit the trial listed and change the status of the trial as not
active.
Creating and submitting a report
Reports can only be submitted for registered active trials that the user is associated to. The
trial and reporter details are automatically populated by selecting the relevant trial. The user is
guided through each step of the online form:
Edit an existing report that has not previously been submitted to the MHRA
This reporting tool allows users to save and edit their reports at a later date for completion prior
to submission to the MHRA. When saving reports, users will be prompted to provide a valid
email address. A ‘key’ (in the form of a unique identifier) will be generated automatically and
displayed on-screen. Users will be required to input both the email and key when they are
retrieving the saved report.
To edit an existing report, users should go to the Reports section within the Accounts page and
click on the Edit icon next to the saved report.
Submit further information for a submitted report as a Follow-up
Follow-up reports are usually submitted to provide further information to that submitted in the
initial SUSAR report (such as an incomplete initial report detailing a fatal SUSAR, or to notify
the MHRA of upgrading a non-fatal SUSAR to a fatal).
To create and submit a follow-up report, users should go to the Accounts page where the listed
reports are located, before clicking on the Follow-up icon next to the relevant submitted report.
Upon submitting a follow-up report, all validation is removed throughout the report form so that
none of the fields are pre-populated.
Create a new report for a new SUSAR as a Copy of a previously submitted report
Users can create a new report for a new SUSAR by using a copy of a submitted report as a
template; for instance, when the same SUSAR occurs in the same clinical trial but to another
trial patient. To do this, users should go to the Reports section within the Accounts page where
the listed reports are found and click on the Copy icon next to the relevant submitted report to
create this new SUSAR.
When submitting a report, a key will also be generated in the same way when saving a report.
Users can retrieve this submitted report to use as a template copy for the new SUSAR by
entering the required email and key.
Users should ensure that all data fields are correctly updated with the relevant information
relating to the new SUSAR.
Summary
The eSUSAR website enables users to create and submit SUSAR reports as well as reports
based on previous submissions. Users also have the option to edit any saved reports prior to
submission and provide further information as a follow-up report.
The online eSUSAR form is a straightforward process that guides the user through each step
of the report. A summary of the data collected is provided at the end of the process allowing
users to make any amendments before submitting the report.
The full report can be downloaded by the user in a PDF or xml format. The latter enables the
institution to inform Ethics Committees of these SUSARs.
Frequently Asked Questions
1) On the eSUSAR reporting page, under Step 3 – Reaction, there is a field for the Start date.
Should we enter the ‘date of the first sign/symptom of the event’ or the ‘date the event became
a SUSAR.’ If it is the former, please could you confirm that this date will not be used to assess
the timeliness of SUSAR reporting (as it may well be some time after the first sign or symptom
of the event that it then progresses to be a SUSAR and subject to expedited reporting).
The date entered should be the date of the first sign/symptom of the SUSAR. For expedited
reporting, the initial report is to be done within seven days after knowledge by the sponsor of
the SUSAR.
2) Whilst we collect various information about concomitant medications on our SUSAR form,
we do not collect concomitant medication product form - is it possible to have an option for
‘unknown’ for this please? In the Detailed guidance on the collection, verification and
presentation of adverse reaction reports arising from clinical trials on medicinal products for
human use - April 2006 product form for concomitant medications is not one of the items listed
in Section 5.1.6.1 (Minimum criteria for initial expedited reporting of SUSARs) and as such we
would not wish not having this information to hold up submission of a report?
The addition of an option for ‘unknown’ may be added in the future during further development
of the eSUSAR website. At the current time, the applicant is advised to submit initial reports
without details of concomitant medication, so as to avoid delays in submission, and to add
these later as a follow-up when further information is available. The applicant is reminded that
as much information as is available should be included with the initial report.
3) One of our options (and quite a commonly used one) for the question ‘Action taken as a
result of the SUSAR’ is Treatment delayed. Would it be possible to add this as an option or
confirm how you would like this response to be entered as none of the existing options seem
appropriate?
The addition of an option for ‘Treatment Delayed’ may be added in the future during further
development of the eSUSAR website. At the current time, the applicant is advised to select the
option of ‘Dose Reduced’ as this is considered to be the closest current match.
4) Some of the Sponsors we work with have requested to be given access to the site for the
trials which they sponsor; however, as they have registered as members under their own
institutions I am unable to allow them access to our institution. Is there any way around this at
all as it seems entirely appropriate that they have access to both.
Users can be registered with more than one Institution. However, a different email address will
have to be used for each registration since this is used as the part of the login identification.
5) I am about to enter the trial details for one of our Sponsors. There is no field for the name of
the Sponsor but I presume that this information can be concluded by the system due to the trial
details such as EudraCT no. etc. Is this correct?
Yes, this is correct; the trial sponsor can be concluded from the EudraCT number and CTA
number.
6) Does the field CTA number refer to the reference number issued by your Authority for the
particular trial? For the Sponsor in question, we as the CRO are responsible for two trials
conducted by the Sponsor with the same study drug. In case of a SUSAR, would we need to
enter the SUSAR details twice, separately for each trial or is it possible to choose more than
one trial when creating a report?
Yes, the CTA number refers to the reference number issued by the MHRA for a particular trial.
Each SUSAR report should only be submitted once. Therefore, if the applicant is responsible
for reporting for two or more trials involving the same IMP, the report should only be submitted
for one trial. Details of any other relevant trials can be included in the additional information
section of the eSUSAR web form.
7) Regarding the field CTA no: for the one of the trials which I have added the CTA number is
12345/1234/001-0001. The 3rd field of the CTA number on the website is shorter than 0010001. This is the same for two other trials I have just added. Could you please clarify how the
number should be entered?
The CTA number field should be completed with just the first three sets of digits. In the above
example ‘12345’, ‘1234’ and ‘001’. The final four digits ‘0001’ are not required to identify the
trial. For information, ‘-0001’ refers to the initial application, ‘-0002’ refers to the first
amendment, ‘-0003’ to the second amendment etc. etc.
8) For an investigational (not yet marketed) product, how can we report cases from a clinical
trial that is conducted outside of the EEA through the eSUSAR portal? These studies do not
have a EUDRACT number or CTA.
At the current time, SUSARs originating in trials that do not have a EudraCT number or CTA
number should be reported under a trial that uses the same IMP, which is being carried out in
the UK and which, therefore, does have an EudraCT number and CTA number. The report
should include a note in the additional information section explaining the origin of the SUSAR
and the Country of Origin field should be selected to indicate the correct origin of the report.
The MHRA are currently developing a more robust method for reporting these SUSARs and it
is anticipated that this will be available in the near future.
9) Is there a mechanism for us to set up a “test” trial and report to use for staff training
purposes?
There is no 'test' function on the eSUSAR website. However, it is possible to fill in an eSUSAR
report up to the point of submission in order to make screen shots for staff training
purposes. Once this new report has been started, it can not be deleted or removed from the
website. However, the information can be edited. Therefore, what we have suggested to other
users is that you edit the 'test' SUSAR data and replace it with the data from your first 'real'
SUSAR (when it occurs) in order to remove the test from your records.
10) What are alternative procedures that sponsors should follow in the incidence of system
failure i.e. the eSUSAR website or the sponsor’s computer facilities including internet/e-mail
access? The European Medicines Agency has very specific procedures to follow in case of
EudraVigilance system failure. These procedures are also suitable for use where the
sponsor’s computer facilities have gone down.
In either of these situations you must contact the MHRA before taking action. If your own IT
has failed then please contact us and we will discuss options with you.
11) We have recently tried to submit a SUSAR via the eSUSAR Reporting Form however, we
have experienced difficulty when a CTA number has been requested as the SUSAR we are
reporting does not have a UK site and therefore does not have a relevant number. The UK
does however; have a clinical trial using the same investigational product. Please could you
advise on how we can proceed with such reports and how we should be reporting them to
you?
In this instance please put in the CTA number of the trial running in the UK.
12) When adding follow-up information to a previously reported SUSAR on eSUSAR, is a new
eSUSAR reference number generated or is this number unique to the event and stay the same
regardless of how many follow-ups are added?
Yes the eSUSAR ID relates to the worldwide case ID to Eudravigilance and this number
changes with each follow-up report.
13) I would like to enquire about how you can delete a report and you have created in error?
The eSUSAR does not currently have the functionality to delete a report. Please simply update
the report when you have a new SUSAR to report.
14) How do I inform the MHRA that an event previously submitted as a SUSAR has been
reclassified and no longer fulfils the requirements for reporting to the competent authority?
If you have a downgraded an adverse event and it is no longer considered a SUSAR then
please email detail of the event including the EudraCT number of the trial involved, the
reference number of the SUSAR and reasons for the down grading of the event to this
address.
15) I need to edit a SUSAR which my colleague started entering onto eSUSAR the other day
but it doesn’t appear to give me the option to edit it. Can you confirm if this can be done as I
know you can do a follow up report for a SUSAR which someone else has entered?
You will need to have administrator user rights.
References
For further information on the eSUSAR form, please send an email with the subject line
eSUSAR Reporting Form to esusar@mhra.gsi.gov.uk.
For urgent enquiries relating to problems issued whilst submitting eSUSAR reports, please
contact the Clinical Trials helpline on 020 3080 6456.
Safety reporting – SUSARs and ASRs:
►www.mhra.gov.uk/Howweregulate/Medicines/Licensingofmedicines/Clinicaltrials/Safetyrepor
ting-SUSARsandASRs/index.htm
eSUSAR Registration Form May 2010:
►www.mhra.gov.uk/home/groups/l-ctu/documents/websiteresources/con082186.doc
eSUSAR website:
► www.esusar.mhra.gov.uk
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