Quantitative Health Sciences Department of the LRI has established the QHS Regulatory Compliance Office (RCO) and the Regulatory Compliance Advisory Committee (RCAC) under the RCO’s direction to provide a program that establishes best practices and regulatory compliance to ensure data integrity in electronic research (e-research). Efforts have focused on the Department’s computing environment, the establishment of a validation master plan (VMP) and standard procedures for the computing environment in addition to validating core software used in conducting federally regulated clinical research studies. The RCO centralizes QHS’ efforts for developing and implementing best practices by bringing together data management, research informatics, statistics and systems expertise to ensure data integrity in research studies.
Please contact Jeanne Mattern, Ph.D., QHS Regulatory Compliance Officer, at 216-445-5775 or matterj@ccf.org for more information about how QHS can assist with your future research study needs.
Lerner Research Institute
Cleveland Clinic, Mail Code NB21
9500 Euclid Avenue
Cleveland, Ohio 44195
