Monitoring Services Available for Pediatric Research Studies
Clinical research monitoring is a key part of the clinical research process, ensuring the safety and accuracy of results. The Pediatric Research Alliance in Atlanta’s Center for Clinical and Translation Research (CCTR) is offering monitoring services in the following situations:
- The study is conducted by a Principal Investigator that is in the Emory Department of Pediatrics; AND
- The study is investigator-initiated; AND
- The study is limited to a single site; AND
- Monitoring is required but not offered by the sponsor/institution
“We are excited to offer a monitoring service,” says Sarah Marie Huban, MA, CIP, CHRC, Director, Clinical Trials, Department of Pediatrics, Emory. “Compliance covers many areas, but the main things are the safety of the participant, the quality of the data, and trial integrity. You need all of those things to make sure that you have successful research.”
Requests for monitoring must be submitted in advance of IRB submission to Mary Mungai and will be considered on a first-come, first-served basis.
“Investigators should consider using the monitoring services mainly for compliance,” remarks Mary Mungai, Manager, Emory-Children's Center Research Unit. Ms. Mungai oversees the clinical research unit and also provides research education for coordinators at Emory’s Department of Pediatrics. She has robust knowledge from working in the field for many years with extensive experience managing clinical research as a coordinator, supervisor, and clinical manager overseeing teams working on clinical trials including industry-funded and federally-funded studies.
“It is very beneficial especially on the compliance side to have a monitor oversee PI-initiated trials. These trials can be a bit challenging because the physician is acting as both the investigator and the sponsor, so it can be easy to miss things. Not all physicians are extensively trained on the regulatory side or have significant exposure to it. For early-stage investigators, a second set of eyes can be valuable to ensure all research activities are implemented according to approved study protocols and current Good Clinical Practice (GCP) guidelines. If there are inconsistencies or noncompliance issues, those can get addressed earlier during the study versus having a line of protocol deviations that could cause auditing issues later.”
About Pediatric Research Alliance in Atlanta
We are a pediatric research alliance that engages the strengths of a number of institutional partnerships, including Emory University, Georgia Tech, Morehouse School of Medicine, the Georgia Research Alliance, and others. The overarching goal of our strategic plan is to enhance the health of children through innovative research efforts.
About Emory + Children’s Pediatric Research Center for Clinical and Translation Research (CCTR)
The Center for Clinical and Translational Research is the virtual home for pediatric clinical and translational research. CCTR 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).