Date Received:
Instructions: The Feasibility Checklist is completed by the Research Administrator and Principal Investigator and submitted to the Entity Leadership conducting the Research Operations Evaluation (“ROE”) along with the following documents: (1) Preliminary Budget; (2) Study Synopsis; and (3) Schedule of Events.
|Date: |Location: |Dept. |
|PI Name: |Employer (if not AHC): |Telephone: |Email: |
|Study Coordinator: |Employer (if not AHC): |Telephone: |Email: |
|Protocol Name: |
|Estimated No. of Subjects |Enrollment Start Date: |Enrollment End Date: |
|Funding Source: Sponsor (specify) | Internally Funded |
|Study Site(s) |
|Please check applicable study site(s): |
| Shady Grove Medical Center | Home Health |
|Washington Adventist Hospital |Reginald S. Lourie Center for Infants |
|Adventist Rehabilitation Hospital of Maryland |& Young Children |
| |Other: |
|Qualifications of Principal Investigator and Study Coordinator |Yes |No |N/A |
|Is the study being submitted by the Center for Cardiac & Vascular Research at SGMC or WAH? | | | |
|Are the Principal Investigator and Study Coordinator capable of performing and managing the procedures required by the protocol? | | | |
|Please review the AHC Research Conflict of Interest Policy and related Disclosure Form. The Disclosure Form is submitted to the IRB for | | | |
|each “investigator” (defined by the policy to include the investigator, research nurse, and/or study coordinator). Is the answer “YES” | | | |
|to any of the questions listed on the Disclosure Form? | | | |
|If the answer is “YES” to any of the questions, you must submit a copy of the completed Disclosure Form to the ROE. | | | |
|B. Budget & Sponsor Obligations Budget & Sponsor Obligations |Yes |No |N/A |
|Is this a Retrospective/prospective chart review study? | | | |
|If yes, skip to E. Recruitment Feasibility | | | |
|Is this an observational study? | | | |
|Sponsor / Clinical Research Organization (CRO) |Yes |No |N/A |
|Has your previous experience with the sponsor been satisfactory? | | | |
|If you have no experience with the sponsor, have you checked the sponsor’s reputation with colleagues? | | | |
|Is the sponsor the “responsible party” to register the trial on ? | | | |
|If yes, has the study been registered? Yes No | | | |
|Is the Principal Investigator the “responsible party” to register the trial on ? | | | |
|If yes, has the study been registered? Yes No | | | |
|Budget & Sponsor Obligations |Yes |No |N/A |
|If sponsor contracts to pay for "evaluable" subjects, is the definition of an evaluable subject clear and acceptable? | | | |
|If the study is canceled prior to enrollment, will the sponsor pay for pre-study activities, e.g., IRB submission, meetings, chart | | | |
|reviews? | | | |
|Will the non-refundable start-up fee cover our initial costs if the trial isn't started due to poor recruitment or some other factor? | | | |
|Will sponsor pay for events that are difficult to budget in advance, such as: | | | |
|Protocol amendments | | | |
|Re-consenting subjects | | | |
|Unanticipated monitoring visits | | | |
|Additional advertisements for recruitment proves difficult | | | |
|Audits (e.g., FDA) | | | |
|Serious Adverse Events | | | |
|Will the sponsor’s preliminary budget cover all study-related costs? | | | |
|Does the research team know how to schedule procedures/tests that are to be billed to the study? | | | |
|Are there standard of care procedures listed in the study that will be billed to insurance? | | | |
|Does the research team know how to schedule procedures/tests that are to be billed to insurance? | | | |
|Will sponsor pay for an adequate number of screen failures? | | | |
|Will sponsor pay for any informed consent translations? | | | |
|Will sponsor pay for translations of subject brochures, instructions, and all other documents? | | | |
|Is the patient stipend provided by sponsor reasonable and includes enough for travel, patient time, parking and other necessary | | | |
|expenditures? | | | |
|Does the sponsor provide appropriate support for advertising and recruitment? | | | |
|Is the sponsor providing adequate funding for recruitment expenses? | | | |
|Recruitment Feasibility |Yes |No |N/A |
|Do you have access to the appropriate patient population? | | | |
|Will you need to recruit patients from external sources? | | | |
|Is the proposed enrollment goal and period realistic? | | | |
|Will enrollment compete with other studies seeking the same patients? | | | |
|Are the inclusion/exclusion criteria overly restrictive? | | | |
|Are vulnerable populations involved, e.g. children, impaired adults with special consent issues? | | | |
|Based on a review of the protocol, are the number of reportable serious adverse events likely to be minimal? | | | |
|Operational Feasibility |Yes |No |N/A |
|Is there adequate clinical, hospital, or research space to support the protocol? | | | |
|Does the protocol appear ethical? | | | |
|Will coordination with other departments/services be required for study visits or procedures? | | | |
|If yes, please list those departments: | | | |
|Do hospital clinical departments (e.g. lab, radiology, pharmacy) meet the protocol requirements? | | | |
|Is the necessary equipment, including ancillary service equipment in other hospital clinical departments, available? | | | |
|If yes, please list the equipment: | | | |
|Is hospital staff capable of performing and managing the procedures required by the protocol? | | | |
|Is the Principal Investigator and research staff capable of performing and managing the procedures required by the protocol? | | | |
Additional Comments:
|Signature of Principal Investigator and Research Coordinator |
| |
|PI Signature: _____________________________ Date: ___/____/___ |
| |
| |
|Coordinator Signature: _____________________ Date: ___/____/___ |
|RECOMMENDATION |
| Approve Study for Submission to IRB |
| Approve Study with Conditions (Explain Below) |
| Deny Study (Explain Below) |
| |
|Recommendation Comments: |
| |
|Signature of the Research Operations Evaluation Chair or Entity President |
| |
|Chair/Entity President: ___________________________________ |
| |
| |
|Date: ___/____/___ |
| |
|VP, CNO: ___________________________________ |
| |
| |
|Date: ___/____/___ |
| |
|VP, CFO: ___________________________________ |
| |
| |
|Date: ___/____/___ |
| |
|VP, Quality: ___________________________________ |
| |
| |
|Date: ___/____/___ |
| |
|CMO: ___________________________________ |
| |
| |
|Date: ___/____/___ |
| |
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