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Safety & Incident Reporting

In accordance with the UK Policy Framework for Health and Social Care Research and The Clinical Trial Regulations (for CTIMPs) Noclor must ensure overarching systems are in place for the sponsor (where the sponsor is a Noclor partner) to record, investigate and report adverse events and incidents to safeguard research participants and ensure the integrity of outcome data.

This safety and incident reporting section looks to provide researchers with an overview of the reporting requirements for heath research sponsored by a Noclor partner. The Principal Investigator must ensure that the dignity, rights, safety and well-being of subjects are given priority at all times and should consider what actions, if any, are required and in what timeframe.

It may be necessary during the course of a study for an Investigator to implement an immediate change to the protocol (Urgent Safety Measure) or for the Chief Investigator/sponsor to implement a Temporary Halt to the study in order to protect patients from immediate hazard, in these instances please refer to the relevant sections for further guidance.

Safety Reporting

The detailed processes (and defined responsibilities) for the recording and reporting of Adverse Events (AES) including Adverse Reactions (ARS), Serious Adverse Events (SAEs), Serious Adverse Reactions (SARs), Suspected Unexpected Serious Adverse Reactions (SUSARs) and Pregnancy should be managed in line with the protocol and the relevant Noclor Safety Reporting SOPs.

For clinical trials, the Chief Investigator will be required to sign to acknowledge that they have read and understood the relevant Noclor SOPs prior to study activation. If sites are required to follow Noclor Safety Reporting SOPs also (i.e where the reporting requirements and procedures are not clearly defined in the protocol or in study specific SOPs this will be identified during risk assessment/sponsorship request and will be included in the study-specific monitoring plan (a checklist item for signature by PI to acknowledge receipt and review of the relevant Noclor Safety Reporting SOPs at site initiation prior to study activation).

Researchers should also consider whether adverse events reported through the Noclor safety reporting procedures also require reporting as an incident or event according to local Trust policy and procedure.

Noclor has devised a Safety Reporting Toolkit which allows researchers to test out various scenarios for the different study types; CTIMPs or all other research that involves participants, to assess the seriousness and relatedness of the event to the research procedures and be presented with the definition of event type and the associated reporting requirements for that event (i.e relevant to the assessment/responses that have been entered into the toolkit).

Incident Reporting

It is important that research related adverse incidents (and near misses) are treated in the same way as non-research related adverse incidents. All Trusts have a responsibility to report adverse incidents relating to research to the National Patient Safety Agency according to their local incident reporting policies. The sponsor also has a responsibility for investigating and reporting serious breaches (unreported incidents could escalate to potential serious breaches further down the line if left unreported).

Research related adverse incidents encompass a whole range of research related activities, unlike safety reporting which relates to medical events for participants receiving IMP or other interventions/study procedures. Incidents (or near misses) may include: incidents that involve staff or a carer/visitor during the course or a research study (for example: - a member of staff maybe injured whilst administering an intervention or the carer may take trial medication in error); incident relating to the premises (for example :- discovery of asbestos, burglary, fire); equipment failure, data loss and breaches in confidentiality etc.

Any research related incident reported locally (within a Trust) for a research study sponsored by a Noclor partner should also be notified to the Noclor Sponsor Representative. This should be done directly through the incident reporting system where possible by including as one of the reviewers of the incident report. Noclor will ensure reported incidents are sufficiently addressed and closed, cross referenced where necessary (i.e where the incident is also an participant specific adverse event requiring reporting within the trial) or further investigated /escalated if a possible serious breach has been identified.

The Chief Investigator should file trial specific incident reports (and related correspondence) in the Study/Trial Master File (S/TMF).