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pJKefaYqNoFx6hNrdQcJ262CVVNTAHg8Hcjv3EBVe6thzMfqLzp4EPvgozEAstpoYX97zJnUoPaY6KEq2QeJWKQMfXyjrFTDy

Clinical Trials Protocol Feasibility Checklist

Please complete the Protocol Feasibility Checklist below and submit with the application form.

Thank you!

Other

Is qualified staff available?

* must provide value

Yes

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If needed, is training available?

Yes

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Does the PI have adequate time to devote to the protocol?

* must provide value

Yes

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If additional specialists needed, are there individuals prepared to participate?

* must provide value

Yes

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Is a draft consent form provided by the sponsor? (Staff-written consent forms take time.)

* must provide value

Yes

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Are study visits manageable given current scheduling environment? (Consider how many different study staff will subjects encounter in a given visit)

* must provide value

Yes

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Is projected query turnaround time workable?

* must provide value

Yes

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Does sponsor's preliminary budget appear adequate?

* must provide value

Yes

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If sponsor contracts to pay for "evaluable: subjects, is the definition of an evaluable subject clear and acceptable?

* must provide value

Yes

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If the study is canceled prior to enrollment, will the sponsor pay for pre- study activities, e.g., IRB submission, meetings, chart reviews?

* must provide value

Yes

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If not paying for a full-time coordinator, will sponsor pay for events that are difficult to budget in advance?

* must provide value

Yes

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Protocol amendments (may require consent form revisions)?

* must provide value

Yes

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Re-consenting subjects?

Yes

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Unanticipated monitoring visits?

* must provide value

Yes

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Will sponsor pay for an adequate number of screen failures (especially important for difficult protocols)?

* must provide value

Yes

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Will the proposed payment schedule allow you to keep afloat, e.g., adequate up-front payment; payments paced according to work required by protocol?

* must provide value

Yes

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Will sponsor pay for study record storage?

* must provide value

Yes

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Will sponsor pay for informed consent translations?

* must provide value

Yes

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Is adequate clinic and office space available?

* must provide value

Yes

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If the sponsor acknowledges that the study may be
audited by the FDA, is extra time built into the budget for audit preparation? (FDA audits take staff time.)

* must provide value

Yes

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Will the sponsor provide additional time reimbursement for their own audit procedures (and
is this acceptable)?

* must provide value

Yes

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Will electronic or remote data retrieval systems be used? If so, will sponsor provide training?

* must provide value

Yes

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Have you considered the sponsor's site monitor visit schedule? (Frequent visits will consume staff time may help to minimize the number of data queries).

* must provide value

Yes

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If the monitor needs to meet with the PI at every site visit, is this level of cost built into the budget?

* must provide value

Yes

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Is time spent at an investigator meeting fully covered as a non-refundable start-up expense?

* must provide value

Yes

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Audits?

* must provide value

Yes

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Unexpectedly high number of SAEs?

* must provide value

Yes

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Has your previous experience with this sponsor/CRO been satisfactory?

* must provide value

Yes

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If you have had no previous experience with this sponsor/CRO, does the sponsor's/CRO's reputation check out with colleagues?

* must provide value

Yes

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Do you have access to the right population?

* must provide value

Yes

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Will you be able to recruit patients from internal sources?

* must provide value

Yes

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If not, will sponsor provide funding?

* must provide value

Yes

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Is the proposed enrollment goal realistic?

* must provide value

Yes

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Will enrollment compete with other studies seeking the same patients?

* must provide value

Yes

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Is the proposed enrollment period realistic?

* must provide value

Yes

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Are inclusion/exclusion criteria reasonable? (Consider the likely screen failure ratio and the number of screen failures for which the sponsor will pay).

* must provide value

Yes

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Do you expect that the adverse event profile is reasonable? (Consider the health status of the population.)

* must provide value

Yes

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Is the protocol well designed?

* must provide value

Yes

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Is the protocol ethical? (Or, will the IRB have concerns....)

* must provide value

Yes

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Is the study question important?

* must provide value

Yes

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Will the subjects benefit from participating in the study?

* must provide value

Yes

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Is the protocol in final form? If not, how many amendments can be expected before it is in final form? (Consider your time required to review each amendment.)

* must provide value

Yes

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Will coordination with other departments/services be required for study visits or procedures?

* must provide value

Yes

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Can other services (e.g., lab, radiology) meet the protocol requirements?

* must provide value

Yes

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Is necessary equipment available?

* must provide value

Yes

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Is this a Phase III b protocol? (drop-outs may be more likely if the study drug becomes commercially available while the study is still underway.)

* must provide value

Yes

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Is the study of reasonable length in duration? (Drops-outs are more likely in long studies).

* must provide value

Yes

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If an inpatient study and floor staff are needed, has this been cleared appropriately?

* must provide value

Yes

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Is patient compliance anticipated? (Consider additional time and expenses to monitor subjects' compliance with time consuming phone calls or postcards)

* must provide value

Yes

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Are case report forms reasonable (Not overly complex)?

* must provide value

Yes

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Is the number of case report forms per subject reasonable?

* must provide value

Yes

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Are drug or device storage/accountability requirements clearly defined and manageable?

* must provide value

Yes

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Will the drug be available for patients at the end of the study? (This can impact patient satisfaction.)

* must provide value

Yes

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Are procedures carefully planned to avoid inconvenience, where possible?

* must provide value

Yes

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Are procedures not too difficult? (e.g. elderly patients asked to swallow large pills)

* must provide value

Yes

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Are procedures carefully considered to avoid pain?

* must provide value

Yes

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If subject diaries are used, will staff time for transcription or interpretation be available and covered by the sponsor?

* must provide value

Yes

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Is the dosing scheduling reasonable

* must provide value

Yes

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Is the sponsor willing to consider suggestions or modifications?

* must provide value

Yes

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