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Risk Assessment

There are risks associated with specific activities and tasks during the course of any research study.  The sponsor should be aware of the potential risks and hazards associated with a specific study (and the ‘harm’ that the hazard would result in should it occur) prior to agreeing to act as sponsor. 

Noclor (where a Noclor partner is requested to act as sponsor) must be assured that any monitoring plans to mitigate the identified risks for a study are proportionate to those risks (i.e to lessen the likelihood of their occurrence) and that they will be able to maintain oversight /discharge their sponsor responsibilities on the study thus ensuring that participants are safeguarded and results are reliable.

Noclor apply risk-proportionate and adaptive management systems to research sponsored by a Noclor partner and will ensure that potential (foreseeable) risks associated with a study are assessed prior to sponsor declaration (as part of the sponsorship request process) and on an ongoing basis (for example further to review of study procedures/documentations or as a result of revisions to the protocol, reports of non-compliance etc). 

Although risk management is the responsibility of all parties involved and is a continuous process, the key contributor to the early identification of potential risks will be the Chief Investigator. S/he will be asked for their initial contribution to the risk assessment through the online sponsorship request form.

Depending on the study type a further bespoke risk assessment may be required prior to sponsorship being declared.

CTIMPs

The Chief Investigator should consider the risks of the proposed research during protocol development so that mitigation plans can be built into a workable and ethical protocol from the outset.  The Chief Investigator must populate the sponsors' CTIMP protocol template and  involve Noclor as early as possible in the study design and development phase to ensure that any sponsor requirements or procedures in regards to The Clinical Trial Regulations can be incorporated within the protocol.

In the sponsorship request form the Chief Investigator will be asked to categorise the IMP risk of the proposed CTIMP into Type A, B or C (A lowest risk, C highest risk). This category relates to risks of participant safety in relation to the IMP. The  IMP should be categorised according to how much is known about the IMP and balanced against the level of risk that the trial participant would be exposed to outside of the trial.  The IMP risk should be assessed according to the categories in Risk-adapted Approaches to the Management of Clinical Trials of Investigational Medicinal Products. The IMP risk category will be confirmed by Noclor during the risk assessment process (after a sponsorship request has been submitted).

The IMP risk category can help to provide an indication of overall risk to a participant (patient safety), however the potential risks associated with the management and conduct of the study/reliability of data must not be overlooked (the ‘other’ risks such as Chief Investigator/Study team experience can often pose a higher risk to the sponsor organisation’s reputation as the likelihood of a hazard occurring maybe higher and therefore oversight and monitoring measures will need to be adapted to minimise the risks).

Noclor will review the sponsorship request and depending on the status of the study at the time of the request (i.e the stage of development or set-up ) will arrange a meeting with the Chief Investigator (and others as appropriate).  The Chief Investigator will receive a response from Noclor (either a request for further information or to arrange a meeting) within 5 working days of Noclor receiving a valid sponsorship request form.

The sponsorship request form will act as the foundation on which a full bespoke CTIMP risk assessment will be built.  A full risk assessment that involves a multi-disciplinary team (Chief Investigator, Noclor Sponsor Representative and Clinical Trial Pharmacist/Technician (as a minimum)) will need to be conducted and documented prior to any decision on sponsorship being made.

The initial risk assessment will be used to inform the overall approach for managing the study and the monitoring plan that must be finalised ready to implement prior to study activation

The risk assessment should be clearly documented, authorised (signed off by relevant parties) and retained in the Trial Master File (TMF) as a key document. Any reviews /revisions to the initial risk assessment should be documented (made clear on version /date) and signed off before being filed in the Trial Master File (TMF)

Clinical Trials

The Chief Investigator should consider the risks of the proposed clinical trial during protocol development so that mitigation plans can be built into a workable and ethical protocol from the outset.

The Chief Investigator will be asked for their initial contribution to the risk assessment through the online sponsorship request form.

Noclor will review the sponsorship request and depending on the status of the study at the time of the request (i.e the stage of development or set-up) will arrange a meeting with the Chief Investigator (and others as appropriate). The Chief Investigator will receive a response from Noclor (either a request for further information or to arrange a meeting) within 5 working days of Noclor receiving a valid sponsorship request form.

The sponsorship request form will act as the foundation on which a full bespoke clinical trial risk assessment will be built.  A full risk assessment will need to be conducted with the Chief Investigator and documented prior to any decision on sponsorship being made.

The initial risk assessment will be used to inform the overall approach for managing the study and the monitoring plan that must be finalised ready to implement prior to study activation

The risk assessment should be clearly documented, authorised (signed off by relevant parties) and retained in the Trial Master File (TMF) as a key document. Any reviews /revisions to the initial risk assessment should be documented (made clear on version /date) and signed off before being filed in the Trial Master File (TMF).

Other Research

The Chief Investigator should consider the risks of the proposed research during protocol development so that mitigation plans can be built into a workable and ethical protocol from the outset.

The Chief Investigator will be asked for their initial contribution to the risk assessment through the online sponsorship request form.

The level of risk assessment required for studies that are not categorised as clinical trials will be adapted to the specifics of the study for which the sponsorship request is being made.  Various factors will be considered from the information submitted via the online sponsorship request form (such as study type, study population, Chief Investigator expertise, complexity, whether third parties are involved, whether protocol has been peer reviewed, funding) in reaching the decision as to whether further risk assessment is required or whether Noclor have enough information and evidence on which to base the sponsorship decision from review of the online form. 

Noclor will respond to the Chief Investigator with either a sponsorship decision or a request for further information within 5 working days of receiving a valid sponsorship request form.

A copy of the submitted sponsorship request form should be retained by the Chief Investigator in the Study Master File (SMF) as a key document.