Post approval conduct

Trust sponsored studies

The Trust has a comprehensive monitoring programme which monitors its own studies on a risk assessed basis through its monitoring programme.

All amendments to Trust sponsored studies are reviewed by the DRM prior to sponsor authorisation via the Research Office, before submission to the ethics committee (or HRA).  It is the lead researcher’s responsibility to distribute amendments to other sites for multi-site studies.

It is the chief investigator’s responsibility to comply with Research Ethics Committee (or HRA) requirements for an annual progress report, end of study notification and final report.  The Research Office should be copied in when these are submitted.

All researchers should comply with the Trust’s Research Policies and SOPs available on the intranet policies pages.

All patient recruitment data should be entered on to R-Peak, the Trust’s research management system, in a timely manner.

The Research Office must be notified when recruitment is closed and when the study has finished (follow up has closed).

Researchers must respond to queries regarding data for the NIHR Performance in Initiation and Delivery (PID) submissions.

All adverse events for our patients or Trust sponsored trials must be sent to the Research Office at adverse.events@cmft.nhs.uk.

Trust sponsored CTIMPS

All Trust sponsored CTIMPs are managed via the Research Office and Chief Investigators should discuss any aspect of their management as directed at trial initiation.

Trust hosted studies

The Trust expects sponsors to conduct appropriate monitoring of their studies.

All amendments should be notified to the Research Office at R&D.applications@cmft.nhs.uk and have received R&D approval (or appropriate local process under HRA approval guidance) prior to implementation unless patient safety would be compromised.

All researchers should comply with the Trust’s Research Policies and SOPs available on the intranet policies pages.

All patient recruitment data should be entered on to R-Peak, the Trust’s research management system, in a timely manner.

The Research Office must be notified when recruitment is closed and when the study has finished (follow up has closed).

All financial matters must be settled prior to finishing on site.

Researchers must respond to queries regarding data for the NIHR Performance in Initiation and Delivery (PID) submissions.

All adverse events for our patients must be sent to the Research Office at adverse.events@cmft.nhs.uk.

All site inspections by statutory bodies (eg. MHRA, FDA) must be notified in advance to the Research Office.