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Clinical Research Toolbox

The sections below provide information and resources that may be required for initiating and conducting research procedures. If you are new to research, please review the "Getting Started with Clinical Research" presentation.

You can find information about hospital capacity and statistics in Quick Facts About WFBMC.

For questions, please contact Nancy Lawlor, nlawlor@wakehealth.edu.

ClinicalTrials.gov Guidance

The Food and Drug Administration Amendments Act of 2007 (FDAAA or US Public Law 110-85) was passed on September 27, 2007. This law requires mandatory registration and results reporting for certain clinical trials of drugs, biologics, and devices. To comply with all regulations, we strongly recommend registering your trial prior to any enrollment of participants. In addition, the International Committee of Medical Journal Editors and other journals require registration of clinical trials prior to enrollment of the first participant. 

ClinicalTrials.gov is a web-based registry of federally and privately supported clinical trials conducted in the United States and around the world. It is sponsored and supported by the National Institutes of Health and its National Library of Medicine in conjunction with the FDA. Each listing in ClinicalTrials.gov outlines the purpose of the study, defines its recruitment status, lists the disease or condition associated with the study, gives an overview of the study design, and provides the participation criteria and contact information.

The CTSI offers support and consultation in ClinicalTrials.gov processes. To request a ClinicalTrials.gov service, please complete the CTSI Service Request Form and select the “ClinicalTrials.gov Support/Consultation” option.

For help navigating ClinicalTrials.gov, please contact Issis Kelly Pumarol at ikellypu@wakehealth.edu or (336) 716-8372. 

Determining Feasibility of Research Protocols

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.

External Services

Information about external courier and dry ice services available for researchers.

Courier Services

We have a stat courier service that will pick up and deliver your specimens where the need to go! 

  • Call for information: 336- 413-1231
  • Call to schedule pick up: 1-855-933-6368
  • Prior to 3:30 pm: no fee 
  • After 3:30 a new service has come on board: DeliveryonTime (DOT). DOT can accommodate any time required 24/7.

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 Delivery

  • 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 cragsdal@wakehealth.edu. 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 ea 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.

Long-term Storage

  • 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.

Establishing External Monitor Access

Guidance on collaborating with external entities and monitors.

External Monitor Access

The WakeHealthLink Third Party/Reviewer Access Request 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 so that they can be handled in a swift fashion:

jbmoore@wakehealth.edu
sstanfie@wakehealth.edu

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.

The IRB will notify you once the form has been approved and forwarded to Health Information Management (HIM) (Medical Records). You should receive an email from HIM including temporary password and User ID within 5 days. You can then email Debbie (Schultz) Mayfield, djmayfie@wakehealth.edu  to request study subjects to be added to monitors' access. 

Equipment, Labs, and Pharmacy Information

Information about equipment, laboratories, and pharmacy services available for research at the medical center.

  • Equipment Calibration:
    Scales can be calibrated by the Clinical Engineering Department you make 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, ReynoldsTower: 336-716-4741 
  • Research MRI and CT Scanning: Debra Fuller | dfuller@wakehealth.edu | 336-716-9141  
  • Research Pharmacy, Storage/dispensation: Brian Strittmatter | bstrittm@wakehealth.edu | 336-716-3258
    Please include PI name, protocol, and pharmacy manual. 336-716-3258 
  • Stock Room Pharmacy, Sub-basement pharmacy, Reynolds Tower: 336-716-3374 
  • Store Room Supplies, Front Desk: 336-716-3362
    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. 
    • 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 | fax: (919) 733-0176 | azzie.conley@NCmail.net

In-house Services to Assist with Research

Support services and programs available for biomedical and clinical research.

Patient Transportation and Research Assessments Services

Clinical Research Unit (CRU)

Dermatology Department

  • Contact: 336-716-3926

Main Campus Operating Room

Medical Plaza, Miller Facility (Comp Rehab) Procedure Room

Ophthalmology Services

  • Contact: 336-716-3937

Pathology Department

  • Contact: 336-716-2610

Phlebotomy Training Courses

  • Provided at Wake Forest through the American Society of Phlebotomy Technicians
  • Classes offered twice yearly: Spring and Fall 
  • For further information, please contact: Issis Kelly Pumarol | ikellypu@wakehelth.edu | 336-716-1352

Study Coordinator Pool

The Study Coordinator Pool is available to assist with study start-up, implementation, and close-out. Learn more

Regulatory Guidance

Regulatory Bodies

  • Human Research Protection Program (HRPP)
    The HRPP serves participants in human research by coordinating the safety, ethics, and regulatory reviews of research projects. In addition, the HRPP oversees the conduct of research projects to ensure ongoing compliance with the approved protocol, federal regulation, state and local laws, and institutional policy. Learn more.
  • Institutional Review Board (IRB)
    The IRB reviews all research involving humans to ensure that participants are informed of all known risks posed by a research study and that these studies are conducted in accordance with the ethical standards put forward by the Belmont Report, and federal, state, and local regulations, and policies governing human research. Learn more.

Non-Compliance Citations

The Office of Human Research Protections (OHRP) and the U.S. Food and Drug Administration (FDA) both conduct site inspections to ensure compliance with the regulations that govern human subject research. OHRP has jurisdiction over all Public Health Service funded human subjects research, while the FDA’s Bioresearch Monitoring Program (BIMO) focuses on research that involves drugs, biologics, and devices used in the diagnosis, cure, mitigation, treatment, or prevention of disease. Review common findings of noncompliance discovered during routine and for cause audits by the OHRP and FDA.

Guidance Documents

Reporting Procedures (AE's and Protocol Deviations)

Adverse Events (AEs)
An adverse event (AE) is an unanticipated occurrence that results in increased pain, distress, or health risk to an animal(s) or human(s). Reporting AEs assists the research team, provider or veterinary staff, to determine the cause and to prevent re-occurrence. 

Protocol Deviations
A protocol deviation is any departure from the procedures approved in the IACUC or IRB protocol.

Safety Events
Access the eIRB User's Guide for instructions on how to report a safety event. 

Research teams are required to promptly report adverse events and protocol deviations to the IACUC or IRB, as appropriate. The HRPP assists in resolving issues, developing action plans, and reporting to appropriate federal authorities when necessary. 

Use the resources below for additional help.

Study Log Templates

The logs/templates offered here are samples that you can revise to fit your needs. A study's documentation may or may not benefit from the use of each specific log depending on the logistics required to run the study, the requirements of a study sponsor, and the risk to study participants.

Using Medical Devices in Research

Information on the requirements for using medical devices in research.

Track Core

Devices need to be entered into a Wake Forest system entitled Track Core. This system keeps track of the actual device that was placed into the individual. If issues were to arrive down the road the institution would have record of patient, device and lot #. 

Contact: Kristen Harper | kharper@wakehealth.edu | 336-712-8081

INDs and IDEs

Regulatory support and assistance navigating FDA regulations for Investigational New Drug (IND) and Investigational Device Exemption (IDE) applications is available. Learn more

Working with External Collaborators

Information for Baptist Health Affiliates

Wholly-owned affiliates of Wake Forest Baptist Health should contact the IRB at 336-716-4542 before conducting research involving human participants or allowing human research to be conducted on facility property.  The Wake Forest School of Medicine IRB will determine whether the institution is engaged in the research under the regulations.  If so, IRB review of the study or reliance on the review of another accredited IRB will typically be required.

All affiliate personnel must follow the practices set forth on the "How to Guidance" page in order to conduct research involving people.

Unless otherwise noted below, an investigator at Wake Forest School of Medicine who is familiar with human leading research studies must be identified to serve as an oversight person on the project. 

Resources for External Use/Collaborators