Katharine Bergstrom, MS, CCRP

IRB and Regulatory Specialist

Ms. Bergstrom is CCGHE's IRB and Regulatory Specialist for the Indo-JHU research partnership. She brings more than 15 years of experience to the University, including preclinical and clinical research support, focusing on regulatory, monitoring, and the coordination and management of the development of clinical trial protocols. She provides protocol support, training, and closely collaborates with the US study team and international research site investigators and study personnel to ensure compliance with institutional, local, and national regulatory standards. She provides regulatory support for new and ongoing research studies, as well as for the AIDS Clinical Trials Group Network and the International Maternal Pediatric Adolescent AIDS Clinical Trials Network, assisting with all IRB submissions including new submissions, continuing reviews, progress reports, protocol amendments, adverse events, violations/deviations, and she ensures all required occurrences are reported and reviewed in a timely manner. Additionally, she takes part in research grant coordination and preparation.

Ms. Bergstrom previously worked for Social & Scientific Systems, Inc. with the ACTG Network Coordinating Center managing multiple clinical trials from development of the protocol and opening to enrollment through study completion and manuscript writing. She received a BA in Public and Urban Affairs with a concentration in Non-Profit Management from Virginia Tech and an MS in Biotechnology from Johns Hopkins University. She is a Certified Clinical Research Professional (CCRP) with the Society of Clinical Research Associates (SOCRA).


TREAT Asia Observational Database

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The TREAT Asia Observational Database's primary study objective is to: Examine HIV natural history, including the relationship between access to ART, demographics, and disease progression; short- and long-term responses to ART; impact of co-infections; HIV drug resistance patterns; and toxicity of...

TREAT Asia: Pediatric HIV Observational Database

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TREAT Asia Pediatric HIV Observational Database (TApHOD) is a collaborative observational cohort study of infants, children, and adolescents living with HIV. TApHOD study participants are enrolled and followed at selected TREAT Asia Network clinical sites in the Asia-Pacific region. Participating...