Evaluate elements to successfully conduct a clinical research based on site resources, qualifications, patient population, and infrastructure.
Prior to agreeing to conduct a clinical trial, it is recommended that study teams conduct a feasibility assessment to evaluate if they have adequate resources (personnel, equipment, infrastructure, ancillary support, time commitment, patient population, etc.) as well as interest to successfully complete the study.
Use the questions on this Protocol Feasibility Checklist along with the resources listed under Ancillary Departments and Institutes as a guide to assist in assessing whether MSHS resources or patient populations exist to conduct your potential study.
Sponsor – Site Feasibility Questionnaire
CRO’s or sponsors send out site feasibility questionnaires to potential sites as a means to assess whether the site will be a suitable candidate to participate in the study.
Typical feasibility questions include:
- Qualifications and Experience of the Investigator
- Investigator Success Recruiting for Other Studies
- IRB and Timelines
- Contracting and Budgeting Timelines
- Site Resources and Logistics
- Equipment, Space, IT
- Personnel (Sub-investigator, study nurse, coordinator, regulatory staff)
- Patient Population
- Eligible Patient Population
- Competing Studies
It is recommended that study teams consult with the appropriate ancillary departments and institutes, as well as collaborating investigators, when completing site feasibility questionnaires. Refer to the Find Your Patient Population tool under Resources.
Ancillary Departments, Institutes and CoREs
Biorepository and Pathology CoRE
The Biorepository and Pathology CoRE provide services to support clinical and basic research including:
- Histology, Special Stains and Tissue Microarray Generation
- Immunohistochemical and Immunoflourescent Staining
- Laser Capture Microdissection
- Whole Slide Scanning and Image Analysis
- Molecular DNA/RNA Extraction
- Biorepository – Tissue/body fluid procurement, storage and tracking
Investigators who plan to utilize the Biorepository and Pathology CoRE for their clinical studies are encouraged to contact Rachel Brody, MD, PhD, Director, Institutional Biorepository, to discuss the intended study and research fees.
Transfusion Medicine and Cellular Therapy Laboratories
The Transfusion Medicine and Cellular Therapy Laboratories in the Department of Pathology, Molecular and Cell-Based Medicine provide therapeutic apheresis (TA), blood bank and clinical therapy laboratory services to support clinical research. Investigators planning to use these services should complete and email the Mount Sinai Research Request Form to Jeffrey Jhang, MD, Director of Blood Bank and Transfusion Services. Upon review the study team will be contacted to discuss the study and budget.
Research studies requiring cardiology services or collaboration with a cardiologist should contact Debra Fitzpatrick in the Cardiovascular Institute to discuss the intended study and research fees.
Clinical Research Unit (CRU)
The Clinical Research Unit (CRU) provides infrastructure to perform clinical and translational research studies including:
- Outpatient Space
- Nursing Support
- Specimen Processing
- Walk-in Phlebotomy
Investigational Drug Services (IDS)
If a trial involves complex circumstances pertaining to drugs or biologics, it is encouraged that study teams contact Investigational Drug Services (IDS) to confirm feasibility.
BioMedical Engineering and Imaging Institute (BMEII) provides biomedical imaging support for basic and clinical research including MRIs, and PET scans. Investigators who plan to utilize BMEII services for their projects must reach out during study feasibility to discuss the intended project, protocol feasibility, and any other technical or operational issues.
Research studies requiring ophthalmological services or collaborations should contact Jill Slutsky-Sanon in the Department of Ophthalmology to discuss protocol feasibility, required certifications for procedures (OCT, visual fields), and research fees.
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