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Throughout the duration of a research study, investigators are required to report research-related incidents and complaints from research participants to the JRO.
This requirement is stated within the JRO Confirmation of Capacity and Capability/Decision to Deliver confirmation issued prior to study commencing recruitment at UCLH. It is the responsibility of the Chief Investigator and or Principal Investigator , or delegated research staff to report these to the sponsor and participating site.
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:
- the rights or wellbeing of a research participant
- the scientific value of the study
- the compliance of the study/research staff with relevant legislation, e.g. General Data Protection Regulation (2018) or the Human Tissue Act (2004)
- 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 (SADE) 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.
- Reporting research incidents in Research Studies hosted by UCLH
All research related incidents occurring at UCLH should be reported through InPhase, the Trust incident reporting system (available on the UCLH intranet myUCLH); please answer Yes to 'Is this a research related incident?'. When completing the InPhase reporting system the incident reporter must also, as a minimum, provide answers to all questions with an asterisk/*.
Researchers must ensure guidelines and requirements from the Sponsor for reporting research incidents are followed. For other participating Trust sites, the incident should be reported through the respective Trust incident reporting system.
Personal data breaches in studies hosted by UCLH
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.
For UCLH hosted studies personal data breaches must immediately be reported to the UCLH Information Governance team, UCLH.IGQueries@nhs.net, and the UCLH Data Protection Officer, and it must be reported on InPhase. Researchers must also fulfil the requirements of the sponsor for reporting incidents.
Please refer to the UCLH SOP for Reporting and Managing Events and Incidents for further guidance.
- Reporting research incidents in UCL/UCLH Sponsored Studies
In addition to specific site host reporting requirements, it is mandatory the JRO (as sponsor representative) is informed when an incident occurs 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 also take into account reporting requirements of your protocol and Sponsor:
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 should be reported directly to the respective Unit, via their reporting guidance and SOPs. UCL sponsored CTIMPs and Medical Device Clinical Investigations All research incidents should be reported to the JRO by emailing jro.sponsorship@ucl.ac.uk UCL sponsored non-CTIMPs (JRO managed studies) For UCL sponsored studies hosted at UCLH , you must report research incidents using both JRO REDCAP Incident Reporting Form and InPhase. All completed reports, queries and letters should also be sent to research-incidents@ucl.ac.uk.
For UCL sponsored studies where UCLH is not the host you must report using the JRO REDCAP Incident Reporting Form and follow the host sites procedures for reporting research incidents. All completed reports, queries and letters should also be sent to research-incidents@ucl.ac.uk.
UCLH sponsored non-CTIMPs (JRO managed studies) For UCLH sponsored studies incidents should be reported using InPhase. All completed reports, queries and letters should also be sent to research-incidents@ucl.ac.uk. 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 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 (DPO) (as per form and guidance: Report a Breach of Personal Data | Data Protection - UCL – University College London), and to the Sponsor via the JRO REDCAP incident reporting form. If UCLH is the host site it must also be reported on InPhase and other participating research sites must additionally follow their Trust incident reporting mechanisms and document any breaches within their TMF/ISFs.
UCLH sponsored studies: Personal data breaches must immediately be reported to the UCLH Information Governance team, UCLH.IGQueries@nhs.net, and the UCLH Data Protection Officer, and to the Sponsor via InPhase.
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.
Please refer to the UCLH SOP for Reporting and Managing Events and Incidents for further guidance.
- 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; copying in jro.sponsorship@ucl.ac.uk.
Where the sponsor is UCLH, the complaint should be reported via uclh.randd@nhs.net .
UCLH Site: Complaint from NHS patient NHS Trust Complaint Manager
UCL/UCLH Sponsored Study: UCL: research-incidents@ucl.ac.uk and jro.sponsorship@ucl.ac.uk
UCLH: uclh.randd@nhs.net
