Upcoming CCTS Events
Project Panels leverage the community of scholarship across the CCTS Partner Network to work with you to brainstorm ideas, generate research questions, meet possible collaborators, fine-tune study design and sharpen your proposals. Whether you want a multi-disciplinary panel for your proposal or a quickly-deployed, tailored group, we assemble the expertise needed to work with you to strengthen your project.
A Nascent Project Panel (NPP) might be right for you!
A Panel Done Quickly (PDQ) might be right for you!
An Innovation Panel (iPanel) might be right for you!
The Translational Investigator Exchange Service (TIES) might be right for you!
Not sure which approach would be best for you?
Additional CCTS resources:
The UAB Hospital Investigational Drug Service in the hospital's Department of Pharmacy stores and distributes investigational drugs prescribed for patients hospitalized at UAB Hospital. Our investigational drug pharmacist can assist you in planning and executing clinical trials using investigational drugs. The pharmacist can also assist in the randomization and blinding process. Note: Commercially available drugs may be considered investigational if the drug is obtained by the investigator outside of the normal hospital purchasing process.
Investigators are strongly encouraged to meet with the investigational drug pharmacist prior to enrolling subjects in order to develop study-specific orders and review drug dispensing processes. Fees to assist investigators are negotiable; however, this should be done before the study is ready to be implemented.
Pharmacy Facility
We provide limited-access, locked ambient refrigerator and freezer storage for investigational drugs within the central, storeroom, and research pharmacy areas of North Pavilion.
We use appropriate workspaces within the Central Pharmacy 797 clean room for the preparation of injectable doses.
We follow Alabama State Board of Pharmacy laws regarding space, storage and labeling.
Ambient temperature is thermostatically controlled to allow for a temperature range of 68°F (20°C) to 77°F (25°C). Limited space is available for storing drugs at 2-8°C, -20°C, and -80°C. Within-range documentation is provided daily.
Study Approval
Investigators must submit protocols to the pharmacy department at the time the study is submitted to the IRB. A completed Release of Drugs for Human Use Form (FOR217) must accompany the protocol. The current version of this form is available on the IRB website. Completing this brief form provides needed budgetary and logistical information not always contained in a protocol.
Fees
When human use studies are reviewed the current fees that are recognized as applicable will be posted on the Release of Drugs for Human Use Form (FOR217).
For questions related to fees, please email
Subject Enrollment
In order to ensure that drug supplies are available at the time a subject is enrolled, the investigator or the designee must contact the investigational drug pharmacist when screening candidates for a study.
Drug Handling Activities
Prior to dispensing, the pharmacist(s) must be notified in writing of the patient’s enrollment and will be provided a written order. Drug storage, inventory maintenance, preparation and dispensing activities are protocol-specific. Documentation of dispensing will be maintained in the pharmacy until after the study is closed. Records will be transferred to the investigator after the completion of the study
Destruction of Drugs
Immediately after a dose or a prescription is prepared and dispensed, supplies used in the preparation are handled as hazardous waste. Unused drug supplies may be destroyed at the UAB Incinerator. A destruction fee will be assessed.
From study start up through implementation and reporting to close out, our Clinical Research Support Program (CRSP) unit offers flexible, cost-effective services to research teams across the lifecycle of a clinical study. Our goal is to provide a "Best Clinical Practice" environment, facilitating the highest quality clinical research and ensuring rigor and transparency. We offer expertise in NIH, industry, and investigator-initiated trials.
CRSP Services
- Start Up: Feasibility, regulatory requirements, budgeting, contract negotiation
- Implementation: Coordination; recruitment (from screening through consenting, enrollment, and scheduling visits to follow up); monitoring; data collection, entry, QC; specimen collection; helpful tools (sample logs, SOPs, checklists), and IND-IDE, Regulatory support, Coordination (skilled nurse and non-nurse)
- Reporting: ClinicalTrials.gov expertise, FDA and internal audit support
- Training: Our CRSP team comprises certified and highly experienced clinical research nurses, non-nurse coordinators, and regulatory and data personnel who provide guidance via educational workshops, drop-in clinics, and seminars. CRSP staff are also available as consultants or mentors on a per-hour, fee-for-service basis.
To find out about the latest learning opportunities as soon as they are announced, subscribe to CCTS Digest and check our Events and Upcoming Office Hours web pages.
Fees
Access a list of CRSP fees here (BlazerID & login required).
Register
To register for a CRSP service, please complete the CBR-CCTS-OCS Submission Form.
Don't see what you need? Have an urgent request? Contact us at
The Clinical Research Unit (CRU) is committed to providing investigators and their teams a research environment and broad range of services guided by good clinical practice. This contributes to the conduct of excellence in clinical and translational research. The unit equips investigators with essential tools and critical resources, while providing a highly efficient and flexible infrastructure that is sustainable through a comprehensive cost-recovery system. Located within the 15th floor of Jefferson Towers, the CRU consists of:
- Large 6 Chair Infusion Suite
- 5 Exam/Procedure Rooms
- 10 Chairs and 3 Beds
- Max Capacity of 13 Patients
Nursing Services
Our experienced team of clinical research nurses are specially trained to assist you in the conduct of your studies. The nursing staff has a breadth of clinical and research experience that encompasses clinical care on a continuum of healthy volunteers to complex disease processes. Our nursing practice is guided by scientific knowledge, standards of care, and a code of ethics.
We facilitate new studies by working closely with the research nurse coordinators to meet the specific needs of each protocol. We also facilitate staff education by coordinating in-services and ensuring staff have the knowledge needed to effectively carry out a research protocol.
CRU Services & Capabilities
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Register
The first step in accessing CRU services is registering. The following information is required:
- A completed Registration Form
- Human Subjects Protocol (approval may be pending — send stamped approval form when available)
- Consent Form(s) (approval may be pending — send stamped consent form(s) when available)
- Protocol (Grant application, sponsor protocol, study group protocol)
The registration form and accompanying documentation should be sent electronically to:
Study Initiation
After registering, you will receive an official letter from us that details the services to be used and any requirements to initialize the study. This letter must be signed by the PI and returned to us before the study can begin (Step 2).
Study Implementation
The third step is to hold an in-service for CRU nurses. An in-service should be scheduled at least two weeks prior to the first scheduled participant appointment. Email
Scheduling Participants
After the in-service is completed, you can begin scheduling participants to receive CRU services. Call 205-934-6669 or email CRU Nurse Manager Joshua Vernon to schedule appointments for participants. A series of visits may be scheduled at one time to ensure availability of resources.
Outpatient: 15th floor of Jefferson Tower (625 19th Street S.).
Inpatient: 8th floor Medical Education Building (1813 6th Ave. S.).
Coordinator Tools
We offer several helpful tools for study coordinators. Available on request.
- Coordinator Checklist
- IV Infusion Sheet
- Oral Drug Flow Sheet
- OGTT Flow Sheet
Don't see what you need or have an urgent request?
Contact us at
CRU Nurse Manager: Joshua Vernon, RN;
CRU Medical Director: Pankit Vachhani, MD;