Resources and information for determining the feasibility of your proposal, including institutional information and patient demographics.
Common Feasibility Questions from Sponsors
Ethics
1. Will the subjects benefit from participating in the study?
2. Is the protocol ethical?
Population
1. Do you truly have access to the right population? (see Patient Demographics below)
2. Will you be able to recruit?
3. Is the proposed enrollment goal realistic?
4. Will enrollment compete with other current studies seeking the same patients?
5. Are study visits complex, presenting possible scheduling difficulties, e.g., how many different study staff will subjects encounter in a given visit?
Protocol
1. If an inpatient study, will floor staff need to be involved?
2. Does the PI have adequate time to devote to the protocol?
3. Can institutional services meet the protocol requirements?
Facilities
1. Is there space in the department for subject visits?
2. Is it confirmed with department head that space is available? Is the CRU an option?
3. Are drug or device storage/accountability available if not utilizing the research pharmacy? Is there a locked cabinet with monitored temperature log?
Study Staff
1. Are there available sub-investigators to assist with the trial?
2. Are there available raters needed to perform exams/questionnaires?
3. What special training do study staff need (inquire to sponsor)?
Equipment
1. Is the necessary equipment available in-house?
2. Is the sponsor supplying any equipment (e.g., EKG machine, urine pregnancy testing, urine drug testing, or other study specific equipment)?
3. Will coordination with other departments/services be required for study visits or procedures?
Patient Demographics
The Translational Data Warehouse (TDW/i2b2) allows users to query clinical data for simple demographic analysis and cohort identification.You can run a query for generalized criteria in i2b2 prior to receiving IRB approval.
Data available includes: demographics, diagnoses, procedures, medications, lab results, and vitals. The CTSI can also provide training so that researchers and study staff can query the Data Warehouse on their own.
Request access to the TDW and i2b2 through the CTSI Service Request Form.
*Shuttle service - per institutional policy: Shuttle should not be used as a courier service for transporting specimens of any sort.
*Private vehicle: Your private insurance company may not cover you if you are transporting biological specimens in your personal vehicle at the time of an accident. Contact your insurance company to confirm.
Dry Ice may be purchased at the Clinical Research Unit (CRU)
Dry Ice CRU In-House Purchase:
Thank you for your interest in purchasing dry ice. You can pick up the dry ice in the Clinical Research Unit, Main Floor Progressive Care Building. We require a 24 hour notice prior to pick-up. We do understand that circumstances may arise that you need dry ice ASAP so please call (336) 716-9752 to make sure we have enough in stock.
To setup an account please complete the forms below and send to cru@wakehealth.edu. A SPID number will be assigned and emailed to you within 24 hours.
- Contact Missy Parmesano at 336-725-8811 or missy@archiveim.com to order boxes and forms.
- You will need authorization from the Department Business Administrator.
- Address: 1325 Ivy Ave, Winston Salem, NC 27105
The WakeHealthLink Third Party/Reviewer Access Request Form (click view>edit in order to fill out the form) is required for setting up external research study monitor access into for monitor visits. Monitors will be given individual logins and passwords in the Managed Access portion of WakeHealthLink which will allow for appropriate access controls and tracking.
The individual login and password credentials for monitor access to WakeOne WakeHealthLink will be good for the life of the study so you will only need to request access for each monitor once.
The IRB will have a database on monitors and can cross-reference the email addresses provided on request forms to check for those who have existing WakeHealthLink accounts. If a monitor already has an account we will advise you of this so you can set up your pick-list for view in that account.
You will receive an email from the service desk to confirm account has been set up and provide you access to the Wake One “Patient List”.
Request Monitor Access
Release Records to Monitor Process
- Equipment Calibration
- For calibration of Clinical Equipment (Scales, Blood Pressure machines…) Contact Clinical Bio-Management at 833-267-5302.
- Complete Lab, Customer Service: 336-716-2610
- ECG - Lab/Heart Station, Ground Floor, Reynolds Tower: 336-716-4741
- IATA Shipping Certification:
- Course: WFB-Shipping Biological and Infectious Substances
- Description: Required training for personnel who package and ship Class 6 Category B (biological and infectious) substances
- Estimated Time: 15m
- Link: Course available here
- Renew certification every 2 years
You may reach out to John Strong for the certificate after course completion. 336-716-9681
- Research MRI and CT Scanning: Lena Mortez | 336-716-3415 | lmoretz@wakehealth.edu
- Research Pharmacy, Storage/dispensation and fee rates: Brian Strittmatter | bstrittm@wakehealth.edu | 336-716-3258. Please include PI name, protocol, and pharmacy manual.
- Shipping Dock: Check on deliveries: 336-716-9310, ext.11
- Stock Room Pharmacy, Sub-basement pharmacy, Reynolds Tower: 336-716-3374, Open Mon - Fri: 8 am - 4 pm
Pharmacy Request Form - Store Room Supplies, Sub-basement, Front Desk: 336-716-3362, Open 7 days a week, 6 am - 6 pm
Equipment Request Form - CLIA Waivers for Investigators and Departments
- To perform urine pregnancy testing, urine drug testing, etc. in an individual department, the PI or department will need to apply for a CLIA waiver.
- Go to “Point of Care Testing” under Departments on intranet home page
- Resources tab> Resource Links > Regulatory > CLIA Application –Form CMS 116 >
- Scroll to bottom complete the form entitled: CMS 116 PDF.228KB (under related links)
- Remember: If you are applying for CLIA waiver you will need to use only CLIA waived testing devices.
- Lab Director named on the form to complete is the PI who the CLIA will be listed under.
- For questions, please contact:
Azzie Conley
North Carolina Department of Health and Human Services
Division of Health Service Regulation/CLIA Certification
2713 Mail Service Center
Raleigh, NC 27699-2713
919-855-4620 | 919-733-0176(FAX) | azzie.conley@NCmail.net
- To perform urine pregnancy testing, urine drug testing, etc. in an individual department, the PI or department will need to apply for a CLIA waiver.
Here is some new information:
Please send all RFP Vendor Requests to askap@wakehealth.edu going forward. Also, there are three new vendor forms on the Intranet; one for PO Vendors, RFP Vendors, and one for Study Participants.
You can find these forms by going to Depts – Financial Services – Accounts Payable (left hand side) – all three new vendor forms are near the bottom.
We will require a W9 going forward, please do not use a substitute W9. Each form will direct to you to the correct department for setting them up. If you have the old documents attached this time, we will honor them. We understand that there will be a transition period that we will have to adjust to.
Also, per internal audit, all individuals being setup as a vendor require a middle name/initial. Please place N/A or NMN on the vendor form (only if you have verified that they do not have a middle name).
Contact: askap@wakehealth.edu for questions
Resources:
