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After the study has been approved, investigators are required to report complaints from participants and incidents in the event of either occurring.
COMPLAINTS FROM PARTICIPANTS
NHS participants: In the first instance, all complaints from participants who are NHS patients should be reported to NHS complaints manager at the Trust where the study procedures or enrollment was undertaken and also to the Sponsor.
Where the sponsor is UCL then the complaint should be reported through research-incidents@ucl.ac.uk.
Complaints from NHS patients are handled under the NHS procedures with involvement from the Joint Research Office where necessary.
Volunteers ie those not recruited through the NHS: Complaints from volunteers should be reported through research-incidents@ucl.ac.uk. The Complaints from Research Subjects about UCL Sponsored Studies and Trials policy should be followed.
INCIDENTS IN RESEARCH STUDIES HOSTED BY TRUSTS
A reportable incident is EITHER something which should have happened in a study but did not OR happened but should NOT have happened which significantly effects
a. the rights or well being or a research subject
b. the scientific value of the study
c. the compliance of the study with relevant legal rules or ethics guidance including the Data Protection Act of the Human Tissue Act
d. UCL's or Trusts reputation
For UCLH such incidents should be reported through the Trust incident system Datix and the box research related should be ticked.
For other Trusts, the incident should be reported through the Trust incident reporting system.
INCIDENTS IN UCL SPONSORED STUDIES
Where the study is managed by PRIMENT, CRUK and UCL Cancer Trials Unit or UCL Clinical Trials Unit then all incidents and adverse events should be reported to those Units.
For other studies sponsored by UCL which are not hosted at NHS site, the following should be reported using the Incident Report Form. When you have completed a form please send an email to research-incidents@ucl.ac.uk.
1. all incidents
2. Serious Adverse Events (SAE) in studies other than CTIMPs
3. Serious Adverse Devices Events (SDAE) in Devices Trials
4. Breaches of study protocol
5. Breaches of GP if applicable
