Georgia CTSA Clinical Research Centers (GCRCs)


 

The Georgia CTSA Clinical Research Centers (GCRCs) offers a dedicated space, experienced research staff, and resources ranging from core laboratory services to a bionutrition unit to support research at a competitive cost. Investigators from Emory University, Morehouse School of Medicine, Georgia Institute of Technology, Children’s Healthcare of Atlanta, and the University of Georgia are eligible to request GCRC’s support. Learn more information about protocol submission below.

CR-Assist Login

GCRC's Resources

Laboratory Services

To effectively serve the Georgia CTSA, the Bionutrition Unit of the Emory University Clinical Research Network is staffed 8:00 a.m.-5:00 p.m. Monday through Friday. The Metabolic Kitchen also operates 8:00 a.m.-5:00 p.m. Monday through Friday.

The Bionutrition Unit, including a Body Composition Lab and an Exercise Lab, is available for investigators interested in conducting well-controlled human feeding studies, assessing body composition, and conducting exercise tests on various populations. The unit is staffed by an experienced, technically skilled research dietitian with expertise in exercise studies. The unit consists of a full-scale Metabolic Kitchen providing experimental research diets for both inpatient and outpatient studies.

The unit also provides support for protocol development, food compositing, food record analysis, dietary data management, and technical support. The Body Composition and Exercise Labs are available for objective determination of resting energy expenditure, body fat percentage, extracellular/intracellular fluid volume, and VO2 max and anaerobic threshold measurements.

The Body Composition Lab is equipped with a Dual Energy X-ray Absorptiometry (DXA) machine, a BOD POD body composition tracking system, and three separate bioimpedance analysis machines. Anthropometry is available as well.

The Exercise Lab is equipped with a Vmax Encore metabolic cart for resting energy analysis, and a new state-of-the-art Vyntus CPX metabolic cart (with treadmill and bike options) for VO2 Max and VCO2 measurements.

Please contact Bionutrition Research Manager for pricing.

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Contact

Erin Millson, MS, RD, LD

404-712-7239

erin.johnson2@emory.edu

Clinical Data Extraction Service Center

Self Service via the ACT Network

If you are an Emory or Morehouse School of Medicine investigator then you are eligible for access to the ACT Network which is a real-time platform allowing researchers to explore and validate feasibility for clinical studies across the NCATS Clinical and Translational Science Award (CTSA) consortium. Access for Georgia Tech and UGA investigators is in development.

ACT helps researchers design and complete clinical studies, and is secure, HIPAA-compliant and IRB-approved. Please visit the ACTNetwork website to learn more about the ACT Network and to register for the service.

Fee-Based Data Extraction Service Requests

The CTSA Clinical Data Extraction Service Center provides investigators seeking access to information residing within the Clinical Data Warehouse of Emory Healthcare. Fee-based services include:

  • Aggregate population queries for pre-research
  • De-identified clinical data extraction
  • Defining cohort populations for retrospective studies or patient recruitment
  • Extraction of clinical information for current study populations
  • Assisting with the migration of clinical data to research data repositories

The service center is organized to work with an investigator initially to determine the scope, deliverables, timeframe, and cost of a project.

Required documentation for data extraction requests:

  • IRB approval or renewal letter
  • A copy of the research proposal
  • HIPAA waiver or consent documents
  • Recommended: Complete a Studio Consultation prior to submission to speed process

Note: The Georgia CTSA Clinical Research Centers (GCRCs) partner with the Clinical Data Extraction Service Center to offer this resource at a reduced cost to the investigator. To request GCRCs support for Clinical Data Extraction Service Center projects, please mark the appropriate box on the Protocol Submission Form and the request for support will be reviewed at the Scientific Advisory Committee meeting.

For additional information on data extraction requests please contact datasolutions@emory.edu.

Laboratory Services

The Core Laboratory offers:

  • Sample processing to fit your protocol needs
  • Short- and long-term sample storage (4°C, -20ºC, -80ºC)
  • Sample barcoding and tracking using sophisticated Laboratory Information Management Software (LIMS)
  • Laboratory expertise for your protocol planning, set-up, and initiation

* Limited after-hours processing - Contact laboratory for specific details

Locations and Hours of Operation

Emory University Hospital

1364 Clifton Road, Ground floor, Room GG-07
Atlanta, GA 30322
Hours: Monday - Friday 7:00 a.m. - 3:30 p.m.
(Samples are accepted until 2:30 p.m.)
404-727-7350

Grady Memorial Hospital

80 Jesse Hill Jr. Drive, Room 8A012
Atlanta, GA 30303
Hours: Monday - Friday 7:00 a.m. - 3:30 p.m.
(Samples are accepted until 2:30 p.m.)
404-616-5400

Emory University Midtown

550 Peachtree Street
Davis-Fischer Building, 2nd Floor
Atlanta, GA 30308
404-727-7350

Please contact GCRC Administration for more information, GCRC@emory.edu

Laboratory Certifications and Documentation

Georgia CTSA GCRC Laboratories

CLIA Waivers:

Emory Healthcare Medical Laboratory
Grady Hospital Medical Laboratory

All sample processing requests or appointment requests to the Emory University Hospital Clinical Research Site, Grady Clinical Research Site, and Emory Midtown Clinical Research Site must be submitted through the Clinical Research-Assist (CR-Assist) system. CR-Assist complies with Emory University's HIPAA security policies and procedures.

Log in to CR-Assist

Why use CR-Assist?

CR-Assist is designed to help Georgia CTSA investigators/coordinators manage participants, track study visits and submit electronic appointment requests to our Clinical Research Site (CRS) schedulers, and print sample collection labels. Some of the features of the application are listed below.

  • Excel-like participant lists which allows users to add/edit/sort/lookup participants with their visit information
  • Study Calendar to help you plan your team's activities
  • Real-time CRS availability calendar
  • Electronic submission of CRS appointment requests and receipt of pager/email notification on the status of appointment
  • Generation of recruitment report
  • Data export to Excel for generating mailing labels and contact list
  • Secured access from anywhere with Internet connection

What do I need to access CR-Assist?

Your study must be established in CR-Assist and you must be on the list of personnel who has access to the study. You also need an Emory University Network ID or Emory Healthcare ID which should be received at hire. If you are not an Emory employee, you can get a sponsored account. See this link for details. If you need access to an existing study in CR-Assist, please fill out the CR-Assist Access request form. Other than that, all that is needed is a computer that has Internet connectivity.

Starting a new study

We now use RedCap surveys for all new CR-Assist Study, Study Visit, and Study Access forms. Study teams will received an automated survey invitation from RedCap to complete new CR-Assist Study, Study Visits, and Study Access forms after the SAC application is approved. If you need to have a CR-Assist Setup survey resent for completion, please contact Kateisha Oladipo.

CR-Assist Training and Job Aid

If you need CR-Assist Training, please contact Kateisha Oladipo. If you prefer, you may refer to the CR-Assist Job Aid for a step-by-step guide to using CR-Assist.

Nursing Philosophy

We believe our nursing staff have the responsibility to maintain a controlled environment conducive to scientific research and to ensure that all participants receive the highest quality nursing care while participating in research studies. In keeping with the American Nurses Association (ANA) Code of Ethics for Nurses, we hold the belief that “the primary role of the nurse in all research activity is ensuring that subjects are aware of the potential risks and are protected to the greatest extent possible from those risks.” The nursing staff will protect the rights and the confidentiality of the study participant, at the same time ensuring that neither patient safety nor study fidelity are compromised. Nursing staff have the responsibility to report to the investigator and to the Unit Director any component of a study or incident that may compromise the health or rights of the patient.

Nursing Duties
  • Medication administration including research drugs
  • IV access
  • Intravenous infusions
  • Routine and complex vital sign monitoring
  • Admission and shift assessments
  • Phlebotomy
  • Timed specimen collections
  • Telemetry monitoring

Georgia CTSA Clinical Research Centers (GCRCs) Nursing Staff

The GCRCs nursing staff consists of experienced, skilled nurses who demonstrate a high level of clinical expertise, critical thinking, and complex decision making skills. They are attentive to the requirements for precision in sample collection.

Patient Care

As the research participant's advocate, the GCRCs nurse protects and respects the rights of the participant, provides a safe environment, assesses the participant's biophysical and psycho-physical condition on admission to the unit. Also, the nurse assesses the patient's knowledge and understanding of the study, test, and procedures and educate appropriately. Collaboration with the investigator is imperative to ensure all components of the study are implemented as outlined in the research protocol and appropriate flow sheets, forms, equipment, and supplies are available at implementation. The nursing staff is continually developing new skills to meet protocol requirements.

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Contact

Rebecca Shelton-Thomas, DNP, RN

404-727-3538

rebecca.s.thomas@emoryhealthcare.org

GCRCs Phlebotomy 101 Training

Phlebotomy 101 is an introductory training to venipuncture. The two-day classroom and clinical, hands-on training teaches venipuncture. The course is offered to research coordinators bi-monthly.

The Phlebotomy 101 training is led by GCRCs nurses Vani Manoharan, RN, DeBorah Rowser, RN, and Rebecca Thomas, RN. The course is now offered to Morehouse School of Medicine (MSM) and University of Georgia (UGA) faculty and staff.

Current Phlebotomy 101 Training Schedule

Registration
Phlebotomy Course Registration Documents
Pre-Registration Requirements
  1. Cost for the training course is $580 paid with a valid department speedtype.
  2. Complete HLC Module “Venipuncture Reminders” #40039x for University employees or #40039 for Emory Healthcare employees.
  3. Complete and pass Post-test module with at least 80% score.
  4. Print module certificate to be submitted as for Phlebotomy Training 101 participation.
Registration Instructions
  1. Register through Emory Learning Management Systems (ELMS). Under "Find Learning" search for course number 312233 or Phlebotomy 101. 
  2. Complete Registration Form 
  3. Submit the following to: GCRC@emory.edu
  4. HLC module certificate of completion
  5. Principal Investigator or Supervisor's recommendation letter
  6. Registration Form
  7. Current Resume
  8. Copy of CPR Card*

*Note: The Office for Clinical Research offers CPR only for those who need it for Emory Healthcare credentialing purposes. If you do not fit, you can obtain CPR certification from AHA trainer Derek Johnston who provides training on Emory campus.

Register

Investigators must apply to the Georgia CTSA Clinical Research Centers (GCRCs) Scientific Advisory Committee (SAC) for use of the inpatient and/or outpatient nursing units and/or use of resources provided by the Core Laboratory and Bionutrition services. Investigators from Emory University, Morehouse School of Medicine, Georgia Institute of Technology, and University of Georgia are eligible to request resources from the GCRCs. All other designated Georgia CTSA investigators who have representation from one of these institutions as part of their investigator team are also eligible. Information for investigators and on specific Clinical Research Sites can be found here.

Forms and Templates

SAC Application

Protocol Application and Review Process

  1. Please complete the SAC application online in REDCap. You will be prompted to upload a copy of the study protocol, a draft of the day-to-day orders, a consent form, etc. If you have any questions about this form, please email GCRC@emory.edu. We offer an expedited review process for qualifying studies. You will be notified if your protocol requires a full SAC review.
  2. For UGA protocol submissions please email Bradley Phillips, Pharm D-bgp@uga.edu.
  3. For MSM protocol submissions, please click here to be directed to the application submission page.
  4. When writing your study proposal, remember that in order for any costs of the study to be paid by the GCRCs, projects must be either original hypothesis-driven projects or clearly intended to obtain pilot data for a hypothesis-driven project. Industry-sponsored research may be performed in the GCRCs, but all costs must be paid by the sponsor, please see GCRCs Cost Recovery Policy and Fee Schedule above. The funding agency award must be reviewed with the GCRCs management, before the SAC review. Please email GCRC@emory.edu or call (404)712-1993/(404)727-3845 for budget review.
  5. The support requested of the GCRCs should only represent coverage of an unmet need. The resources committed by GCRCs cannot duplicate support from other sources. It is the responsibility of the investigator to ensure that what is requested does not duplicate existing sources of support, but the GCRsC management will work with you to review your award(s) during the review process. Emory's Office for Clinical Research (OCR) may also need to review your proposal. Billing forms that direct charge to your award as well as billing forms directing charges to the GCRCs grant may be required.
  6. Please email GCRC@emory.edu or call (404)727-3845/(404)712-3581 with any questions regarding your protocol submission. We also suggest that you contact one of the GCRCs program directors to discuss your planned protocol and research needs in advance. The GCRCs staff is happy to assist you with all aspects of the protocol submission process. You may be contacted for submission clarifications by the GCRCs nursing, core lab, bionutrition, or business managers during the review period. A checklist of required documents along with forms and templates can be found above.
  7. For Grady-based protocols: In addition to materials presented in this section, see above for the additional form required by the Grady Research Oversight Committee (ROC).
  8. All patient-oriented research and proposed budgets must be approved through the GCRCs SAC. The protocol must also be approved by the Emory University Institutional Review Board (IRB). Application to both the GCRCs and the IRB may be made simultaneously. The actual research protocol submitted to the IRB does not need to be modified for submission to the GCRCs. The IRB letter of approval, along with the IRB-approved consent form must be submitted to the GCRCs Administrative Office before a research participant can be admitted to the patient care unit.
  9. All GCRCs protocols that go through a full-SAC review must be approved by the GCRCs Biostatistician. New protocol submissions will be pre-screened by the Biostatistics, Epidemiology, & Research Design (BERD) program of the Georgia CTSA. The investigator will be contacted should any questions or concerns arise with the statistical design and analysis plans.

Contact

GCRCs Clinical Research Sites:

Site Contact Information:
  • Center for Advanced Pediatrics:
  • Emory University Hospital/Emory University Hospital - Midtown/Grady Hospital:
  • Morehouse School of Medicine:
  • University of Georgia: