Is qualified staff available?
* must provide value
Yes
No
If needed, is training available?
Yes
No
Does the PI have adequate time to devote to the protocol?
* must provide value
Yes
No
If additional specialists needed, are there individuals prepared to participate?
* must provide value
Yes
No
Is a draft consent form provided by the sponsor? (Staff-written consent forms take time.)
* must provide value
Yes
No
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
No
Is projected query turnaround time workable?
* must provide value
Yes
No
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
No
If not paying for a full-time coordinator, will sponsor pay for events that are difficult to budget in advance?
* must provide value
Yes
No
Protocol amendments (may require consent form revisions)?
* must provide value
Yes
No
Yes
No
Unanticipated monitoring visits?
* must provide value
Yes
No
Will sponsor pay for an adequate number of screen failures (especially important for difficult protocols)?
* must provide value
Yes
No
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
No
Will sponsor pay for study record storage?
* must provide value
Yes
No
Will sponsor pay for informed consent translations?
* must provide value
Yes
No
Is adequate clinic and office space available?
* must provide value
Yes
No
Will the sponsor provide additional time reimbursement for their own audit procedures (and
* must provide value
Yes
No
Will electronic or remote data retrieval systems be used? If so, will sponsor provide training?
* must provide value
Yes
No
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
No
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
No
Is time spent at an investigator meeting fully covered as a non-refundable start-up expense?
* must provide value
Yes
No
Audits?
* must provide value
Yes
No
Unexpectedly high number of SAEs?
* must provide value
Yes
No
Has your previous experience with this sponsor/CRO been satisfactory?
* must provide value
Yes
No
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
No
Do you have access to the right population?
* must provide value
Yes
No
Will you be able to recruit patients from internal sources?
* must provide value
Yes
No
Is the proposed enrollment goal realistic?
* must provide value
Yes
No
Will enrollment compete with other studies seeking the same patients?
* must provide value
Yes
No
Is the proposed enrollment period realistic?
* must provide value
Yes
No
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
No
Do you expect that the adverse event profile is reasonable? (Consider the health status of the population.)
* must provide value
Yes
No
Is the protocol well designed?
* must provide value
Yes
No
Is the protocol ethical? (Or, will the IRB have concerns....)
* must provide value
Yes
No
Is the study question important?
* must provide value
Yes
No
Will the subjects benefit from participating in the study?
* must provide value
Yes
No
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
No
Will coordination with other departments/services be required for study visits or procedures?
* must provide value
Yes
No
Can other services (e.g., lab, radiology) meet the protocol requirements?
* must provide value
Yes
No
Is necessary equipment available?
* must provide value
Yes
No
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
No
Is the study of reasonable length in duration? (Drops-outs are more likely in long studies).
* must provide value
Yes
No
If an inpatient study and floor staff are needed, has this been cleared appropriately?
* must provide value
Yes
No
* must provide value
Yes
No
Are case report forms reasonable (Not overly complex)?
* must provide value
Yes
No
Is the number of case report forms per subject reasonable?
* must provide value
Yes
No
Are drug or device storage/accountability requirements clearly defined and manageable?
* must provide value
Yes
No
Will the drug be available for patients at the end of the study? (This can impact patient satisfaction.)
* must provide value
Yes
No
Are procedures carefully planned to avoid inconvenience, where possible?
* must provide value
Yes
No
Are procedures not too difficult? (e.g. elderly patients asked to swallow large pills)
* must provide value
Yes
No
Are procedures carefully considered to avoid pain?
* must provide value
Yes
No
If subject diaries are used, will staff time for transcription or interpretation be available and covered by the sponsor?
* must provide value
Yes
No
Is the dosing scheduling reasonable
* must provide value
Yes
No
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