Clinical Trial Risk Assessment Appendices For COVID19 Responses

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    The below information describes the risk assessment activity undertaken to ensure that we appropriate reviewed the proposed actions for each of the clinical trials in our portfolio. The risk assessment activity we conducted started after more stringent advice came from the Government (public advice) and the MHRA (research advice).

    Our risk assessment process is overseen by our internal oversight committee known as the Quality Management Group (QMG) which is made up of senior staff including myself as the Chair.

    We put out a call to all of our trial management teams to create an appendix to their main trial risk assessment which would be known as the COVID19 risk assessment.

    The risk assessment was broken down into 4 columns titled:

    • Proposed action (response to COVID19)
    • Risk of proposed action to patient safety
    • Risk of proposed action to trial data
    • Proposed response risk mitigations

    The trial teams then detailed how their respective trials intended to proceed in as much detail as possible dependent on the proposed response actions which were listed.

    The submitted risk assessment appendices were reviewed initially by the QA manager (myself), at this point specific risks from each trial were filtered for escalation to the QMG for a more collaborative review and discussion.

    Post review, the decisions and responses from the QMG were relayed to the trial teams and the CIs. Where required the CI and the QMG were involved in teleconferences to iron out the details of proposed actions. Ultimately as the delegated sponsor for our trials we maintained the overall responsibility for the decision(s) taken.

    The biggest risk was regarding patients in the at risk category (elderly) for COVID19 who were on CTIMP trials and needed to attend clinic for safety assessments such as bloods, MRI to enable them to be dispensed further IMP. We deliberated this at length with the CIs and were able to assess against the safety profile of the IMP to allow visits to be changed via protocol amendment and AE data to be collected over the phone.

    Have other units encountered the same issues? What were the outcomes and procedures that were followed?

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