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Assess Protocol Feasibility
Some questions your study team may want to consider before agreeing to do the clinical research study:
- Is the protocol scientifically sound?
- Do we have access to the study subject population for this study?
- Are there any competing studies?
- Can we enroll the number of subjects requested in the allotted time frame of the study?
- How does the study affect subjects care at CHOP?
- Are all the procedures/tests outlined in the study appropriate?
- Is there adequate funding to support this study?
- Are we an add-on site and is the study close to closing to accrual? If so, consider if it is worth the time and effort to start the study for the potential of only enrolling a few subjects or any at all.
- Has the study team consulted with Investigational Pharmacy to assure that the study drug can be formulated for the appropriate patient population?
- Do we have enough staff and resources to support the study?
- Did all the research staff complete CITI and GCP training?
- Does the study have a favorable risk-benefit assessment?
- Have all the risks of the research been minimized?
Examples which may prohibit an investigator from participating in a potential clinical research study:
- There are 5 other studies recruiting the same subject population and we only see 5 children in a year with the condition being studied.
- The entry criteria are too restrictive given our patient population, making enrollment at CHOP not feasible in the study timeframe.
- The study does not have adequate staffing to meet the recruitment needs such as sitting in the ED for 4 hours each day or traveling to other CHOP sites for subject recruitment and visits.
- The study procedures are too intrusive or challenging for the population being enrolled.
- Some procedures for adult patients may not be able to be performed at CHOP.