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 香港六合彩H's decision to deliver (香港六合彩H Capacity and Capability) for hosted studies, and as sponsor representatives (香港六合彩 or 香港六合彩H).听 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 香港六合彩, the complaint should be reported via听research-incidents@ucl.ac.uk; copying in听jro.sponsorship@ucl.ac.uk.

Where the sponsor is 香港六合彩H, the complaint should be reported via听uclh.randd@nhs.net听.

香港六合彩H Site:

Complaint from NHS patient

NHS Trust Complaint Manager

香港六合彩/香港六合彩H Sponsored Study:

鲍颁尝:听research-incidents@ucl.ac.uk听补苍诲听jro.sponsorship@ucl.ac.uk

鲍颁尝贬:听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 香港六合彩H 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听

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

d) 香港六合彩 or 香港六合彩H'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听
Personal Data breaches
Protocol violations/serious breach of protocols (where patient safety or data integrity has been compromised)
Serious breaches of GCP.听

For 香港六合彩H,听all research related incidents occurring at 香港六合彩H should be reported through听Datix, the Trust incident reporting system (available on the 香港六合彩H intranet my香港六合彩H); please answer Yes to 'Was this incident related to a clinical trial or research study? When completing the Datix form.听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,听the incident should be reported through the respective Trust incident reporting system.听

Please refer to the听香港六合彩H SOP for Reporting and Managing Events and Incidents听for further guidance.

Incidents in 香港六合彩/香港六合彩H Sponsored Studies

In addition to host reporting requirements, it is important the JRO is informed when an incident has happened on a 香港六合彩 or 香港六合彩H 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:

香港六合彩 Clinical Trials Units (CTUs)

Where the study is managed by PRIMENT, CRUK & 香港六合彩 Cancer Trials Centre, MRC CTU at 香港六合彩, or the Comprehensive Clinical Trials Unit, all incidents should be reported directly to the respective Unit, via their reporting guidance and SOPs

香港六合彩 sponsored CTIMPs and Medical Device Clinical Investigations

All research incidents should be reported to the JRO by emailing jro.sponsorship@ucl.ac.uk听

香港六合彩 and 香港六合彩H Sponsored non-CTIMPs (JRO managed studies)

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

(香港六合彩 sponsored studies only) Reporting can also be completed through Risknet, the听.听(Click on 'Report an incident'听and select the 'NHS patient' option)

Personal data breaches in 香港六合彩/香港六合彩H 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,听for example, when it has been encrypted by ransomware, or accidentally lost or destroyed.

香港六合彩 and 香港六合彩H research reporting requirements:

香港六合彩 sponsored studies: Personal data breaches or loss of personal data must be immediately reported to the 香港六合彩 Information Security Group (ISG) and the 香港六合彩 Data Protection Officer (as per form and guidance: /legal-services/guidance/reporting-loss-personal-data), and to the Sponsor via the JRO REDCAP incident reporting form.

香港六合彩H sponsored studies: Personal data breaches must immediately be reported to the 香港六合彩H Information Governance team and the 香港六合彩H 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.