Restarting Clinical Research at CUH: Feasibility Questionnaire

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The clinical research portfolio running at Cambridge University Hospitals Foundation Trust was largely suspended in March of this year as a result of the impact of the Public Health Emergency and the need to focus R&D resources to deliver front-line COVID19-related research and care. We are now commencing a phased return to inpatient and outpatient clinical research activity.

Study re-start will take place via an application process, for all studies seeking to be set up at CUH. This form should be completed by study PI's and will be reviewed by the CUH R&D who will assess whether the study is suitable for restart according to our prioritisation process. Delivery of front-line COVID19 research and care remains the priority, and all research delivery teams working within CUH will be allocated studies with this in mind. R&D will formally re-confirm continued Capacity and Capability (C&C) for existing studies.

Email *

Study Title *

R&D Reference or IRAS Number *

Principal Investigator (PI) Name *

Sponsor Organisation Name *

Please confirm the study/trial has been assessed as ‘viable’ by the the Sponsor, Funder, CI in regard to restarting / starting the study? (Please note that sponsor support for restart will be required prior to a study restart/start date being agreed) *

Yes - sponsor supports the request to restart the study at CUH

No - sponsor is still to be approached

CUH and/or University of Cambridge is Sponsor

Other:

Current Study Status *

In Set Up

In Recruitment

Closed to Recruitment, in Follow up

Other:

In light of the pandemic will the study require amendments to the re-design of the protocol? *

Will the study require an extension to existing grant funds or changes to Excess Treatment Costs and have these been accepted? *

Please confirm which clinical support services are required to deliver your study at CUH. Email confirmation of clinical support services confirming there is capacity to deliver your study within the Trust restart/start process must be received before a decision on restart is made *

Pharmacy

Radiology

Laboratory Services

Cambridge Clinical Research Centre (CRF)

Cambridge Clinical Trials Unit

University facilities

Other:

Required

Will you require CRN nurse support and have you confirmed staff availability and capacity? *

Yes

Other:

Is access to CL3 labs/university lab service and facilities required in this study to process samples/tests? *

Please describe steps you will take to minimise extra visits, for example can any study visits EITHER be integrated into routine inpatient clinical encounters OR be conducted remotely (e.g. via video or telephone call) without the need for face to face interaction. If this is not possible explain why and where visits will take place. *

Does the participant cohort have additional risk to the exposure to COVID-19 (e.g. immunosuppression, diabetes, elderly, other shielded groups). Consider also the involvement of BAME participants (risks vs benefits). If so please describe how these will be mitigated. *

Are clinical areas required in COVID or non COVID areas? *

Will research staff require PPE? Please describe how the risks to staff will be mitigated and detail any additional risks you foresee *

If PPE is required, how will the costs for this be met? *

To restart the study do you need to access a CUH bed (e.g. intensive care)? *

Yes

Is there an additional risk of COVID-19 posed by the intervention based on the participant’s condition? (e.g. does the intervention suppress immunity)? How will this risk be mitigated? *

Please describe the physical access arrangements for participants in terms of social distancing, method of transport - hospital/taxi/public transport. Will they need others to bring them in for appointments? *

How will re-opening/any new access procedures be communicated to participants?

Please detail any additional risks you foresee.

What date do you propose restarting / starting your study? *

YYYY

Do you have confirmation from the clinical service (e.g. outpatients clinic) that they will be able to receive study participants within their service from the start date you propose? This includes integration of research visits into the clinical pathway and the clinical space required. *

Yes

Other:

What plans are in place if the study needs to re-pause? *

How many participants do you anticipate seeing in the next 3 months? *

What is the revised study expected end date? *

YYYY

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