Important COVID-19 update: Please see the below tab for important updates and information regarding clinical and translational research at Emory and Children's during this time.
The Center for Clinical and Translational Research is the virtual home for pediatric clinical and translational research. The Center supports innovative clinical research studies and the translation of basic science discoveries into improved child health.
The Center integrates closely with the Georgia Clinical and Translational Science Alliance (Georgia CTSA), an NIH/NCRR-sponsored component of the CTSA network.
A COVID FORCE (Feasibility and Optimization of Research at Children’s) Collaborative was formed in March 2020. The mission of the COVID FORCE collaborative is to provide strategic coordination to facilitate the best possible research and remove barriers to move all research in this area forward. The collaborative has helped to provide feasibility analyses, harmonized IRB requests, coordinated sample and data utilization and sharing, helped with resource identification and allocation, and more. All investigators engaged in COVID projects or interested in submitting new projects are asked to submit their information via the REDCap COVID survey. This is for any projects conducted by Department of Pediatrics or Children's Healthcare of Atlanta researchers, and/or that will take place in Children's facilities or will involve Children's patients or data. As of May 10, 2020 this collaborative is tracking 49 COVID-related studies. If you are needing information about the studies for communications or other purposes, please contact Julie Sullivan.
The COVID FORCE leadership team:
•Miriam B. Vos, MD, MSPH
•Rajit Basu, MD, MS, FCCM
•Evan Anderson, MD
•Inci Yildirim, MD, PhD, MSc
•Evan Orenstein, MD
•Ann Mertens, PhD
•Stacy Heilman, PhD
•Ann Chahroudi, MD, PhD
For all other non-COVID related research efforts during this time, please refer to your appropriate IRBs, sponsors, and PIs regarding individual research study recruitment, enrollment, visit changes, etc. Note that this situation is rapidly changing, and links and documents will be updated frequently.
Emory's Department of Pediatrics intranet site has a section on Clinical Research during the COVID-19 pandemic. Note that you will need your Emory ID to login to this site.
Emory's Office of Research Administration page is regularly updated with information from sponsors and others regarding research during this time.
Should you have any questions or difficulties accessing these pages, please reach out to Nadine Spring.
To request more information about any of the below CCTR services, please e-mail us.
- Protocol Scientific Consultation: CCTR provides individual scientific consultations for investigator-initiated studies. Please note: a draft proposal or protocol must be submitted prior to the meeting.
- Research/Data Safety Monitoring Plan: CCTR assists investigator-initiated studies by providing remote/on-site interim monitoring visits, assisting in the creation of the data and safety monitoring plan, and the development, implementation and closure of corrective and preventive actions (CAPA). If you would like to set up monitoring visits for your investigator-initiated studies, please contact Nadine Spring.
- FDA regulatory consultations are available to investigators interested in submitting a Pre-IND or IND application. Please contact Kristen Herzegh with any questions surrounding your application or general questions regarding FDA regulatory strategies and submissions.
- Clinical Research Resources: CCTR provides investigators and their teams with a wealth of clinical research resources. To learn more, please click here
- The Center for Clinical and Translational Research periodically hosts special speakers and seminars. These events will be posted on the main Pediatric Research calendar.
- The Pediatric EducAtion Research Lunch Series (PEARLS) was created specifically for and by coordinators and research nurses working in the Department of Pediatrics Emory and at Children's Healthcare of Atlanta. Formats for sessions vary and can include panels, a single speaker, or multiple speakers. All sessions are followed by a discussion or questions and answer. PEARLS is offered monthly on the second Friday of the month at noon. A light lunch is often served. If you would like to suggest a topic or volunteer to present, please email Nadine Spring.
- If you would like to submit a topic or have a suggestion for a seminar, please email the CCTR team.
Guidance for New CDAs/NDAs received by Emory Department of Pediatrics and Pediatric Institute Faculty
Confidential Disclosure Agreements, sometimes referred to as an NDA (Non-Disclosure Agreement) or an RDA (Restricted Disclosure Agreement). Generally speaking these types of agreements outline what information is confidential, what and how information can be shared, and what information should be restricted from other parties. These agreements allow parties to discuss details of their business and inventions without the fear of making important information public.
For new confidential disclosure agreements (CDA) and non-disclosure agreements (NDA), approval is required by the appropriate office. Please review the list below to determine which category best fits the purpose of the new CDA or NDA. When you send an email, please remember to list the Emory PI for the CDA along with the Sponsor’s name and email contact to return the executed CDA.
Where to route CDAs/NDAs
1. CDAs for Industry/Clinical Trials
- For industry clinical trials with a Children’s component (most will fit this), route to Children’s Office of Sponsored Programs
►Process: Send email with the CDA attached to Children's Office of Sponsored Programs
- For industry clinical trials without a Children’s component, route to Emory Office of Sponsored Programs (OSP)
►Process: Send email with agreement attached to Emory Office of Sponsored Programs
2. CDAs for Foundations/Non-Profits and Federally funded trials
- Route to Emory Office of Sponsored Programs (OSP)
►Process: Send email with agreement attached to Emory Office of Sponsored Programs
3. CDAs for Pre-Clinical Studies or anticipation/discussion of potential research
- Route to Office of Technology Transfer (OTT) - including investigator-initiated studies
►Process: Send email with agreement attached to Emory Office of Technology Transfer
4. CDAs for Consulting Agreements
- These need review by your Department and the Dean's office as an external activity
►Process: Submit the agreement as an external activity request in the Emory electronic Conflict of Interest site
- You can view the eCOI submission instructions here.
*If the CDA or NDA does not appear to fit the above categories, contact Nadine Spring.
The Emory-Children's Center Research Unit (ECC-RU) is located on the first floor of the Emory-Children’s Center Building, within the Children’s Specialty Services Clinic. It is Emory University space, managed by the Department of Pediatrics. The ECC-RU is dedicated to clinical research activities and is available for IRB approved protocols conducted by Emory Department of Pediatrics faculty and their team members. The unit contains a research staff work room, storage room, phlebotomy chair, two exam rooms and one interview room which can also be used as an exam room.
The ECC-RU is self-service. Once an appointment is booked in the dedicated on-line scheduling system, the IRB status is verified and the study team is given badge access to the workroom. The study staff is responsible for all subject interactions, including informing the subject of the visit and escorting them to the unit. The rooms are equipped with basic supplies: gloves, sharps containers, foaming hand sanitizer and sanitizing wipes. Anything else will need to be provided by the study team and the room must be cleaned after use. The PI is responsible for overseeing the research activities performed and insuring all staff is appropriately trained and credentialed.
- 2 exam rooms
- 1 consult room
- Research staff work room
- Supply storage room
- Emory Children’s Center, 2015 Uppergate Drive Atlanta, GA 30322
- 1st Floor, Rooms: 164, 170, 172, and 173
- ECC-RU@emory.edu; 404-727-4888
- Nadine Spring, MPH, MS, CCRC; 404-772-5234
For more information, or to schedule an appointment, please click here.
The Pediatric Research Unit (PRU) is the pediatric clinical interaction research site of the Georgia Clinical and Translational Science Alliance (Georgia CTSA), a multi-institutional partnership established to effectively translate scientific discoveries into the clinical setting. The Children’s Pediatric Research Center is designed to provide the necessary infrastructure for investigators to conduct pediatric clinical research.
For more information on the services and facilities, please click here
The Research Office at Scottish Rite supports child health investigators throughout the planning and implantation of their research. The office provides individual consultations, biostatical support, IRB guidance, and Study Coordinator support. The office, located on the ground floor within the medical library, is accessible to investigators around the clock. Computers and workstations are available.
To submit an appointment request, please email us.