title: A tiered quality assurance review process for clinical data management standard operating procedures in an academic health center.
abstract: OBJECTIVE
  Standard operating procedures (SOPs) were once considered the province of the pharmaceutical industry but are now viewed as a key component of quality assurance programs. To address variability and increase the rigor of clinical data management (CDM) operations, the Cincinnati Children's Hospital Medical Center (CCHMC) decided to create CDM SOPs.
  
  
  METHODS
  In response to this challenge, and as part of a broader institutional initiative, the CCHMC leadership established an executive steering committee to oversee the development and implementation of CDM SOPs. This resulted in the creation of a quality assurance review process with three review panels: an SOP development team (16 clinical data managers and technical staff members), a faculty review panel (8 senior faculty and administrators), and an expert advisory panel (3 national CDM experts). This innovative, tiered review process helped ensure that the new SOPs would be created and implemented in accord with good CDM practices and standards.
  
  
  RESULTS
  Twelve fully vetted, institutionally endorsed SOPs and one CDM template resulted from the intensive, iterative 10-month process (December 2011 to early October 2012). Phased implementation, which incoporated the CDM SOPs into the existing audit process for certain types of clinical research studies, was on schedule at the time of this writing.
  
  
  CONCLUSIONS
  Once CCHMC researchers have had the opportunity to use the SOPs over time and across a broad range of research settings and conditions, the SOPs will be revisited and revalidated.
authors.affiliation: Dr. Ittenbach is professor of pediatrics, Division of Biostatistics and Epidemiology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio. Ms. Baker is manager and certified clinical data manager, Division of Biostatistics and Epidemiology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio. Mr. Corsmo is senior director, Office for Research Compliance and Regulatory Affairs, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.
authors.forename: Richard F
authors.initials: RF
authors.lastname: Ittenbach
authors.forename: Cynthia L
authors.initials: CL
authors.lastname: Baker
authors.forename: Jeremy J
authors.initials: JJ
authors.lastname: Corsmo
mesh_terms: D000046:Academic Medical Centers / Q000458:organization & administration*; D003628:Database Management Systems; D016208:Databases, Factual / Q000592:standards*; D063025:Health Information Management / Q000458:organization & administration* / Q000592:standards; D006776:Hospitals, Pediatric / Q000458:organization & administration; D006801:Humans; D007324:Institutional Management Teams; D016347:Medical Records Systems, Computerized / Q000592:standards*; D015279:Organizational Culture; D009937:Organizational Objectives; D011785:Quality Assurance, Health Care / Q000592:standards*; D014481:United States