Research Feasibility Checklist

Revised: March 13, 2018

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
Washington Adventist Hospital Adventist
Rehabilitation Hospital of Maryland / Home Health
Reginald S. Lourie Center for Infants
& Young Children
Other:
  1. Qualifications of Principal Investigator and Study Coordinator
/ Yes / No / N/A
  1. Is the study being submitted by the Center for Cardiac & Vascular Research at SGMC or WAH?

  1. Are the Principal Investigator and Study Coordinator capable of performing and managing the procedures required by the protocol?

  1. 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
  1. Is this a Retrospective/prospective chart review study?
If yes, skip to E. Recruitment Feasibility
  1. Is this an observational study?
If yes, skip to E. Recruitment Feasibility
  1. Sponsor / Clinical Research Organization (CRO)
/ Yes / No / N/A
  1. Has your previous experience with the sponsor been satisfactory?

  1. If you have no experience with the sponsor, have you checked the sponsor’s reputation with colleagues?

  1. Is the sponsor the “responsible party” to register the trial on
If yes, has the study been registered? Yes No
  1. Is the Principal Investigator the “responsible party” to register the trial on
If yes, has the study been registered? Yes No
  1. Budget & Sponsor Obligations
/ Yes / No / N/A

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

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

3.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?

4.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

5.Will the sponsor’s preliminary budget cover all study-related costs?

6.Does the research team know how to schedule procedures/tests that are to be billed to the study?

7.Are there standard of care procedures listed in the study that will be billed to insurance?

8.Does the research team know how to schedule procedures/tests that are to be billed to insurance?

9.Will sponsor pay for an adequate number of screen failures?

10.Will sponsor pay for any informed consent translations?

11.Will sponsor pay for translations of subject brochures, instructions, and all other documents?

12.Is the patient stipend provided by sponsor reasonable and includes enough for travel, patient time, parking and other necessary expenditures?

13.Does the sponsor provide appropriate support for advertising and recruitment?

14.Is the sponsor providing adequate funding for recruitment expenses?

  1. Recruitment Feasibility
/ Yes / No / N/A
  1. Do you have access to the appropriate patient population?

  1. Will you need to recruit patients from external sources?

  1. Is the proposed enrollment goal and period realistic?

  1. Will enrollment compete with other studies seeking the same patients?

  1. Are the inclusion/exclusioncriteria overly restrictive?

  1. Are vulnerable populations involved, e.g. children, impaired adults with special consent issues?

  1. Based on a review of the protocol, are the number of reportable serious adverse events likely to be minimal?

  1. Operational Feasibility
/ Yes / No / N/A
  1. Is there adequate clinical, hospital, or research space to support the protocol?

  1. Does the protocol appear ethical?

  1. Will coordination with other departments/services be required for study visits or procedures?
If yes, please list those departments:
  1. Do hospital clinical departments (e.g. lab, radiology, pharmacy) meet the protocol requirements?

  1. Is the necessary equipment, including ancillary service equipment in other hospital clinical departments, available?
If yes, please list the equipment:

6.Is hospital staff capable of performing and managing the procedures required by the protocol?

7.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: ___/____/___

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Research Feasibility DecisionForm

Revised: March 13, 2018

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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