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The form should be used when reporting incidents in UCL-sponsored studies which are not managed by a trials Unit.Ìý As a guide:

• Researchers running a non-CTIMP study sponsored by UCL need to use the form to report any incidents in the study to the JRO.Ìý An incident might be loss of data orÌýfailure to comply with the protocolÌýor a serious adverse event (SAE).

• Researchers running a CTIMP study managed by the JRO should use the form to report any incident that is not an SAE or suspected unexpected serious adverse reaction (SUSAR).

Researchers need to fill in the new electronic form which can be found in the post approval section of the JRO web pages and send a brief email to (research-incidents@ucl.ac.uk) notifying the JRO that they are reporting an event. All incidents are reviewed by the Clinical Research Governance Committee.

For studies managed by the UCL Clinical Trials Unit, CR UK and UCL Cancer Trials Centre and PRIMENT, researchers should follow the procedures of those trials units.