Conduct of the Sponsored Research

Safety Reporting

Take appropriate urgent safety measures in order to protect research participants against any immediate hazard to their health or safety, without prior authorisation from a regulatory body. Notify the main REC immediately and in any event within three days, in the form of a substantial amendment, that such measures have been taken and the reasons why. Provide copies of the information to the REC that approved the study and LJMU REG.

Report Serious Adverse Events (SAEs) that are related to the study (i.e. they resulted from administration of any of the research procedures) and are unexpected (i.e. not identified in the protocol as an expected occurrence) to the REC that approved the study and the Sponsor within 15 days of becoming aware of the event. Unblind double-blind trials where there are reports of SAEs.

For further information, please refer to Roles and Responsibilities for LJMU Sponsored Research.

Amendments

All substantial and non-substantial amendments should be approved in principle by the sponsor. For substantial amendments to HRA approved LJMU sponsored research, email the following documents to sponsor@ljmu.ac.uk:

Please allow at least 10 working days for sponsor approval of amendments.

Substantial amendments should be notified using a Notice of Substantial Amendment Form. These forms are generated in IRAS by navigating to the Amendments tab of your project form, and clicking 'Create Notice of Substantial Amendment' button. Access to the form will be enabled in IRAS as soon as your Submission History for the REC form shows there is a completed version of your initial application for ethical review. The response you have given to IRAS Filter Question two will ensure that IRAS generates the appropriate type of substantial amendment form for your study. The same Notice of Substantial Amendment form should be used to notify the amendment to all the appropriate bodies i.e. REC, MHRA (CTIMPs) and NHS/HSC.

Non-substantial amendments should be notified using the Non-substantial amendment for NHS studies form. Investigators will receive a categorisation email confirming HRA approval for the amendment confirmed or pending.  In both cases, applicants should communicate this outcome to sites, along with the amendment application that was submitted. This should be sent to both the site research team and the R&D office, and the local CRN. If any amendments are category A or B, sites have 35 days to raise any objections, after which if no objections have been raised, the amendment can be implemented. Category C amendments can be implemented immediately.

Where a HRA review is required, the HRA will review the amendment and issue HRA Approval of the amendment. Applicants should then notify sites of the outcome and provide the final approved documents. The HRA have produced a series of email templates to support sponsors when notifying NHS organisations in England of an amendment and to confirm when an amendment can be implemented. The use of these email templates are optional, however their contents will allow investigators to provide NHS organisations with the information they need to enable amendments to be implemented. The templates can be found below:

  • Category A or B site notification email template where HRA Approval is pending at categorisation
  • Category A or B site notification email, where HRA Approval is issued at categorisation
  • Category C site notification email
  • Amendment implementation email

For further information, please refer to SOP009 Study amendments to NHS REC and HRA Approved Research.

Progress Reports

Studies approved by NHS REC and HRA

Submit Annual Progress Reports to the NHS REC which gave the favourable opinion, the HRA and the Sponsor on the anniversary of NHS REC Favourable Opinion, and annually thereafter until the End of Study Declaration has been submitted to the NHS REC which gave the favourable opinion, the HRA and the Sponsor.

Studies approved by NHS REC only

Submit annual Progress Reports to the NHS REC which gave the favourable opinion and the Sponsor on the anniversary of HRA approval, and annually thereafter until the End of Study Declaration has been submitted to the NHS REC which gave the favourable opinion and the Sponsor.

Studies approved by HRA only

Submit annual Progress Reports to the HRA and the Sponsor on the anniversary of the HRA Approval, and annually thereafter until the End of Study Declaration has been submitted to the HRA and the Sponsor.

For further information please refer to SOP003 Roles and Responsibilities for LJMU Sponsored Research.

Early end/temporary halt to the research

Report early termination or suspension of the research to all relevant review bodies and the Sponsor within 15 days

For further information please refer to SOP003 Roles and Responsibilities for LJMU Sponsored Research.

Research Completion

All studies approved by NHS REC

Upon the completion of the study (in most cases, the date of the last visit of the last participant or the completion of any follow-up monitoring and data collection described in the protocol) submit an End of Study Declaration (within 90 days of the end of the study) and End of Study Report to the NHS REC which gave the favourable opinion (within 12 months of the end of the study) and LJMU REG.

Studies approved by HRA ONLY

Notify the HRA and LJMU REG that the research has ended (in most cases, the date of the last visit of the last participant or the completion of any follow-up monitoring and data collection described in the protocol).

For further information please refer to SOP003 Roles and Responsibilities for LJMU Sponsored Research.