Important COVID-19 update: Please see tabs below 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.
The 6/22/20 Emory IRB Guidelines: Resuming Non-Essential In-Person Human Subjects Research outlines the safety measures required for in-person study activities (for both the participant and the researcher), and describes if and when IRB modifications are required to resume these activities.
- COVID-19 SCREENING QUESTIONNAIRE/SCRIPT
- COVID Research Subject Health Screening Form CCTR template
- Copy of CCTR Template COVID Staff Health Daily Screening Form
- Aflac COVID Wellness Screen SOP
Specifically, we want to draw your attention to the following section:
RESEARCHERS AND PARTICIPANTS SCREENING REQUIREMENTS BEFORE STUDY VISITS
All in-person research requires COVID-19 pre-screening of both researchers and participants:
PLEASE NOTE: While you have flexibility in how you document, the main message is that you NEED to document. See above template examples for screening of research subjects and research staff you may want to use if you haven’t already developed a system. Alternatively, if you are interested in a more centralized system, Aflac, on behalf of Children’s, has created a REDCap form (QR Code below) that they are happy to share (SOPs above). Please contact Leann Schilling with questions.
- Researchers must complete and document a symptom screen, plus the temperature reading if available, on each day that in-person contact is planned with one or more research participants. The symptom screen must be completed prior to in-person contact with a research participant. If your facility does not already provide them, please see the sample screening questions and information script/email (or the other templates/links provided above).
- If your facility is asking every person entering the building to fill out questionnaires that contain similar questions like the ones in sample screening questions and information script/email, please save an unfilled copy for your study records and document that your study team member completed the questionnaire when entering the facility.
- Researchers must take their temperature at home before coming to work and provide the information to the research staff keeping the screen log. If the facility is taking the temperature of employees, researchers may use that reading to their research record, as above.
- If your facility does not already screen patients, you may use the sample screening questions and information script/email (or the other templates/links provided above).
- The participant screening questionnaire, and or other materials must include information about risk factors for severe illness to allow participants to evaluate their individual risk.
- If your facility is asking every person entering the building to fill out questionnaires that contain questions similar to the ones in sample screening questions and information script/email, (or the other templates/links provided above) save an unfilled copy of the questionnaire for your study records and document that participants completed the screen when entering the facility.
- Check the participants’ temperature before they enter the building or area where the research will be conducted (if not done by the facility already).
- If your facility is taking the temperature of every person entering the building, document that subjects likely had a temperature lower than 38c or 100.4 as they were permitted to enter the facility.
- If you are obtaining them, the completed screening questions and temperature reading should be saved in the research record.
This information is also posted at the following link: http://www.irb.emory.edu/forms/COVID-19%20Guidance.html
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 June 12, 2020 this collaborative is tracking 65 COVID-related studies. If you are needing information about the studies for communications or other purposes, please contact Barbara Kilbourne.
The COVID FORCE leadership team:
•Ann Chahroudi, MD, PhD
•Stacy Heilman, PhD
•Miriam B. Vos, MD, MSPH
•Rajit Basu, MD, MS, FCCM
•Evan Anderson, MD
•Evan Orenstein, MD
•Ann Mertens, PhD
•Nitika Gupta, MD
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 Ada Chong.
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 Dr. Miriam Vos.
- 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
CCTR Speakers and Seminars
- 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 Series (PEARS) 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 answers. PEARS is offered monthly on the second Friday of the month at noon. If you would like to suggest a topic or volunteer to present, please email Barbara Kilbourne (interim contact).
- 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 Dr. Miriam Vos.
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
- Tiffany Hughes 404-727-5364
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.
Online Course Catalog with Free Trainings for Clinical Research Professionals
The Georgia Clinical and Translational Science Alliance (Georgia CTSA) and the University of Southern California Clinical and Translational Science Institute (SC CTSI) are collaborating on an exciting new educational venture geared toward clinical research professionals at every stage of their professional development. There is a new Online Course Catalog with free course and program offerings available to clinical research professionals and principal investigators. These courses and programs are created and vetted by experts in cross-disciplinary fields such as instructional design, technology, workforce development, regulatory science, clinical and translational science, and operations.
On completion of a course or program (series of courses), participants earn a certificate or badge with contact hours (continuing education – CE) from an accredited provider. Contact hours can be used to meet requirements for Clinical Research Professional (CRP) certification renewal.
Free, one-time registration to the Georgia CTSA Online Course Catalog is available to the first 400 registrants. Registration provides unlimited access to all courses and programs in the Georgia CTSA Online Course Catalog now and in the future. View the Online Course Catalog to get started.
Currently Available Programs
Legal Aspects for Conducting Clinical Trials, a six (6) course program (6.5 CE- contact hours)
Clinical Trials with Medical Devices, a seven (7) course program (7 CE- contact hours)
Quality by Design (QbD) in Clinical Trials, a six (6) course program (5.5 CE- contact hours)