Resources and information for determining the feasibility of your proposal, including institutional information and patient demographics.
Common Feasibility Questions from Sponsors
1. Will the subjects benefit from participating in the study?
2. Is the protocol ethical?
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?
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?
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?
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)?
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?
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.
- You will need to order a minimum of 10 lbs. of dry ice to avoid losing any.
- Cost per pound is $.49
- Deliveries are available for in house and off campus sites. Contact Catherine Ragsdale at 716-5338 or email@example.com. There are 2 options for deliveries:
- Standing PO: This set up with a specific day to deliver on and can be done once a week, every other week, etc. I would just need to know what day of the week delivery would need to be on and how much Dry Ice and delivery location. We set those PO’s up at 1 EA and a dollar amount to cover for the time period you need (3 months, 6 months a year, etc.). This one you would automatically receive a set amount of dry ice on the day you request each week or every other week, etc.
- Blanket PO: This is set up also at 1 each and a set dollar amount. In this case a blanket PO you would call me when you needed Dry Ice. You would give me the PO#, how much dry ice you need and delivery location. If order placed before 2 pm it would deliver next day. So then each time you needed dry ice you would have to call to order.
- Dry Ice may also be purchased at the Clinical Research Unit (CRU)
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 completed access request form should be sent to the IRB. The forms should be sent as a pdf to both of the following email addresses: firstname.lastname@example.org and email@example.com.
If a monitor already has a WakeOne WakeHealthLink login and password because they are monitoring other studies here, they will not need an additional set of credentials for your particular study. The monitor will be able to see the pick-list you set up for them in their existing WakeHealthLink home-page. If you are unsure as to whether the monitor is working on another study here, go ahead and complete the form. 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”. Below is the tip link to access your patients for your monitor.
Scales can be calibrated by the Clinical Engineering Department you may request this service yearly by contacting them at: 6-1111, option 3 for Clinical Engineering and then option 2 for Clinical Engineering. Other equipment yearly safety check or calibration questions: 6-1111, option 3 for Clinical Engineering and then option 2 for Clinical Engineering.
Complete Lab, Customer Service: 336-716-2610
ECG - Lab/Heart Station, Ground Floor, Reynolds Tower: 336-716-4741
IATA Shipping Certification: Contact John Strong: 336-716-9681, He will assign training to your peoplesoft learning. Request that he forward you the certificate after completion.
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:
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