About the eSUSAR Reporting Form

This page is intended to provide an overview of the eSUSAR Reporting Form functionality.

Institution Registration

Institutions will need to register their details with the MHRA before using the eSUSAR website for the first time. This process registers the institution and a representative of the institution as an administrator. In order to commence the registration process, the representative must complete the eSUSAR Registration Form (available on the MHRA website) and email it to esusar@mhra.gsi.gov.uk with the subject line eSUSAR Registration. The MHRA aims to process eSUSAR registration requests within two working days of receipt of a valid application form.

Using the form

The eSUSAR form has been designed to be intuitive, with clear instructions and an easy to use format. It is hoped that users will quickly understand the administrative aspects of registering new members and creating new trials as well as being able to navigate through the steps involved in creating and submitting a SUSAR report to the MHRA.

Help icons have been included to provide hints and advice at key stages throughout the website. To view the help information simply hold the mouse over the relevant icon and the text will be displayed.

Administration

Institution Management: Following the initial registration process, changes to Institution details can only be made by the MHRA's eSUSAR administrator. All requests to change these details should be made by sending an email to esusar@mhra.gsi.gov.uk with the subject line eSUSAR Administration. Documentary evidence may be requested by the MHRA prior to the implementation of any change.

Member/Administrator Management: Following completion of the registration process, new members and administrators (collectively referred to from hereon in as users) of an institution can be added, and existing member details can be edited, by any administrator of that institution. Administrators can amend their own details in the member management section. There is no limit to the number of users that can be added for each Institution.

Users can be flagged as either active or inactive; only active users have the ability to login. Changes to administrator account access (for example inactivation of an account after an employee has left an institution) can be made by the MHRA's eSUSAR Administrator. Requests should be made by sending an email to esusar@mhra.gsi.gov.uk with the subject line eSUSAR Administration. Again, documentary evidence may be requested by the MHRA prior to the implementation of any change.

When a new user is created, an email notification is sent to the new user's registered email address that will include their login details. The new user will be prompted to change their password at first login.

Trial Management: Administrators of an institution have the responsibility to add and edit trials. It is recommended that, as soon the sponsor receives the Notice of Acceptance from the MHRA for a clinical trial, the trial is created by each institution that has a responsibility for safety reporting in that trial to avoid any unnecessary delays at the time of submission of the first SUSAR report.

As for users, trials can also be flagged as either active or inactive; eSUSAR reports can only be submitted for active trials.

There is no limit to the number of trials that can be created for each institution and there is no restriction on the number of institutions that can submit eSUSAR reports for a particular trial. However, each institution will have to create and maintain its own record of the trial and will only be able to view reports created and submitted by its own users.

Administrators also have the responsibility to associate users with each trial; only users associated with a particular trial will have the ability to submit eSUSAR reports for that trial. There is no limit to the number of users that can be associated with each trial.

Creating and Submitting SUSAR Reports

Submitting SUSAR reports using the MHRAs eSUSAR form is a straight forward and logical process. The trial details are automatically populated in the report by first selecting the trial for which the report is to be made. The form then guides the user through a series of steps collecting information on the trial subject, the reaction and the medication (suspect and concomitant drugs). The reporter details are also automatically populated into the report and are defined by the account information of the logged-in user.

Having completed all relevant fields of the form, a summary of the data is presented for the user to check, giving the opportunity to amend any details prior to submission. The user also has the option to download a full report in either PDF format or as an XML file. Institutions may find these reports useful for informing Ethics Committees of SUSARs.

As well as creating and submitting new reports, users can submit follow-up reports, edit draft reports and create and submit copy reports based on previous reports.

Comments or Question?

If you have any questions or comments regarding the eSUSAR form, please send an email to esusar@mhra.gsi.gov.uk with the subject line eSUSAR Reporting Form.

For urgent enquiries relating to problems encountered whilst submitting SUSAR reports using the eSUSAR form, please contact the clinical trials helpline on 020 3080 6456.