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Research Complaints and Incidents

Throughout the duration of a research study, investigators are required to report complaints from research participants and research-related incidents to the JRO, as part of the conditions of UCLH's decision to deliver (UCLH Capacity and Capability) for hosted studies, and as sponsor representatives (UCL or UCLH).  It is the responsibility of the Chief/Principal Investigator (as applicable), or delegated research staff to report these to the sponsor and participating site.

Complaints from Research Participants

In the first instance, all complaints from participants who are NHS patients should be reported to the NHS Complaints Manager at the Trust where the study procedures or recruitment has been undertaken. Complaints from NHS patients are handled under NHS complaints policies and procedure, with involvement from the JRO where necessary.

Complaints should also be reported to the study sponsor; where the sponsor is UCL, the complaint should be reported via research-incidents@ucl.ac.uk. The UCL Complaints from Research Subjects About UCL Sponsored Studies and Trials policy should be followed.

Where the sponsor is UCLH, the complaint should be reported via uclh.randd@nhs.net .

UCLH Site:
Complaint from NHS patientNHS Trust Complaint Manager
UCL/UCLH Sponsored Study:
NHS Patients

UCL: research-incidents@ucl.ac.uk

UCLH: uclh.randd@nhs.net

Healthy volunteers (i.e. those not recruited through the NHS)

UCL: research-incidents@ucl.ac.uk

UCLH: uclh.randd@nhs.net

Incidents in Research Studies Hosted by Trusts

Research related incidents are all unintended or unexpected events that could have led, or did lead to harm for participants, staff or members of the public receiving care, delivering services or visiting any UCLH site for the duration of the research study. A reportable incident may significantly affect:

a) the rights or wellbeing of a research participant

b) the scientific value of the study 

c) the compliance of the study/research staff with relevant legislation, e.g. General Data Protection Regulation (2018) or the Human Tissue Act (2004).  

d) UCL or UCLH's organizational reputation

Examples of reportable research related incidents are:

  • Incidents/near misses/research concerns
  • Reportable serious adverse events (SAEs) related to the research protocol
  • Suspected unexpected serious adverse events (SUSARs) (for CTIMPs)
  • Serious Adverse Devices Events (SDAE) in Devices Trials
  • Urgent safety measures 
  • Personal Data breaches
  • Protocol violations/serious breach of protocols (where patient safety or data integrity has been compromised)
  • Serious breaches of GCP. 

For UCLH, all research related incidents occurring at UCLH should be reported through Datix, the Trust incident reporting system (available on the UCLH intranet myUCLH); please answer Yes to 'Was this incident related to a clinical trial or research study? When completing the Datix form. The incident reporter must also as a minimum provide the study R&D number, study title, and name of Principal Investigator.

For other participating Trust sites, the incident should be reported through the respective Trust incident reporting system. 

Please refer to the UCLH SOP for Reporting and Managing Events and Incidents for further guidance.

Incidents in UCL/UCLH Sponsored Studies

In addition to host reporting requirements, it is important the JRO is informed when an incident has happened on a UCL or UCLH sponsored research study or trial, this also applies when the study or trial is not hosted at an NHS site.

Please refer to the below reporting streams, and report as per your protocol/sponsor SOPs:

UCL Clinical Trials Units (CTUs)Where the study is managed by PRIMENT, CRUK & UCL Cancer Trials Centre, MRC CTU at UCL, or the Comprehensive Clinical Trials Unit, all incidents and adverse events should be reported directly to the respective Unit, via their reporting guidance and SOPs
UCL sponsored CTIMPsPlease follow UCL SOP for Recording, Management and Reporting of Adverse Events by Investigators
UCL and UCLH Sponsored non-CTIMPs (JRP managed studies)

Complete and submit the JRO Redcap Incident Report Form; alternatively, please email through incident details to research-incidents@ucl.ac.uk.

(UCL sponsored studies only) Reporting can also be completed through Risknet, the UCL incident reporting system. (Click on 'Report an incident' and select the 'NHS patient' option)

Personal data breaches in UCL/UCLH sponsored studies

In some instances, despite risk management and mitigations, personal data breaches may occur throughout the duration of the study. The General Data Protection Regulation (2016/679) broadly defines personal data breaches as a security incident that has affected the confidentiality, integrity or availability of personal data. In short, there will be a personal data breach whenever any personal data is lost, destroyed, corrupted or disclosed; if someone accesses the data or passes it on without proper authorisation; or if the data is made unavailable, for example, when it has been encrypted by ransomware, or accidentally lost or destroyed.

UCL and UCLH research reporting requirements:

UCL sponsored studies: Personal data breaches or loss of personal data must be immediately reported to the UCL Information Security Group (ISG) and the UCL Data Protection Officer (as per form and guidance: https://www.ucl.ac.uk/legal-services/guidance/reporting-loss-personal-data), and to the Sponsor via the JRO REDCAP incident reporting form.

UCLH sponsored studies: Personal data breaches must immediately be reported to the UCLH Information Governance team and the UCLH Data Protection Officer, and to the Sponsor via the JRO REDCAP incident reporting form.

The following information must be provided:

- full details as to the nature of the breach

- an indication as to the volume of material involved, and the sensitivity of the breach (and any timeframes that apply).

Participating research sites must additionally follow their Trust incident reporting mechanisms, and document any breaches within their TMF/ISFs.