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Quality Control Measures over 30 Years in a Multicenter Clinical Study: Results from the Diabetes Control and Complications Trial / Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Study.

Lorenzi GM, Braffett BH, Arends VL, Danis RP, Diminick L, Klumpp KA, Morrison AD, Soliman EZ, Steffes MW, Cleary PA, DCCT/EDIC Research Gro - PLoS ONE (2015)

Bottom Line: Implementation of multicenter and/or longitudinal studies requires an effective quality assurance program to identify trends, data inconsistencies and process variability of results over time.The results are reviewed by a data quality assurance committee whose function is to identify variances in quality that may impact study results from the central units as well as within and across clinical centers, and to recommend implementation of corrective procedures when necessary.Details of the quality assurance plan across and within the clinical and central reading units are described, and quality outcomes for core measures analyzed by the central reading units (e.g. biochemical samples, fundus photographs, ECGs) are presented.

View Article: PubMed Central - PubMed

Affiliation: Department of Medicine, University of California San Diego, La Jolla, California, United States of America.

ABSTRACT
Implementation of multicenter and/or longitudinal studies requires an effective quality assurance program to identify trends, data inconsistencies and process variability of results over time. The Diabetes Control and Complications Trial (DCCT) and the follow-up Epidemiology of Diabetes Interventions and Complications (EDIC) study represent over 30 years of data collection among a cohort of participants across 27 clinical centers. The quality assurance plan is overseen by the Data Coordinating Center and is implemented across the clinical centers and central reading units. Each central unit incorporates specific DCCT/EDIC quality monitoring activities into their routine quality assurance plan. The results are reviewed by a data quality assurance committee whose function is to identify variances in quality that may impact study results from the central units as well as within and across clinical centers, and to recommend implementation of corrective procedures when necessary. Over the 30-year period, changes to the methods, equipment, or clinical procedures have been required to keep procedures current and ensure continued collection of scientifically valid and clinically relevant results. Pilot testing to compare historic processes with contemporary alternatives is performed and comparability is validated prior to incorporation of new procedures into the study. Details of the quality assurance plan across and within the clinical and central reading units are described, and quality outcomes for core measures analyzed by the central reading units (e.g. biochemical samples, fundus photographs, ECGs) are presented.

No MeSH data available.


Related in: MedlinePlus

Data Flow in the DCCT/EDIC Study.The CERC was located at the University of Minnesota, Minneapolis, MN between 1983–2004, and at Wake Forest University, Winston Salem, NC from 2005-present.
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pone.0141286.g001: Data Flow in the DCCT/EDIC Study.The CERC was located at the University of Minnesota, Minneapolis, MN between 1983–2004, and at Wake Forest University, Winston Salem, NC from 2005-present.

Mentions: Following the DCCT, the participants were invited to enroll in the EDIC longitudinal observational follow-up study. Two central coordinating centers, each with distinct functions, support and oversee all of the operational aspects of the EDIC study. The clinical centers are responsible for direct interface with the study participants and data collection, and the central reading units provide technical expertise for the evaluation of laboratory samples, fundus photographs and ECGs (Fig 1). Institutional Review Board (IRB) approval was obtained by each of the individual clinical centers as well as the Data Coordinating Center. Written informed consent was provided by each of the study participants at the clinical centers. Consent for minor participants at study screening and randomization was provided by the minor’s parent or legal guardian, as directed by local institutional guidelines.


Quality Control Measures over 30 Years in a Multicenter Clinical Study: Results from the Diabetes Control and Complications Trial / Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Study.

Lorenzi GM, Braffett BH, Arends VL, Danis RP, Diminick L, Klumpp KA, Morrison AD, Soliman EZ, Steffes MW, Cleary PA, DCCT/EDIC Research Gro - PLoS ONE (2015)

Data Flow in the DCCT/EDIC Study.The CERC was located at the University of Minnesota, Minneapolis, MN between 1983–2004, and at Wake Forest University, Winston Salem, NC from 2005-present.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4631458&req=5

pone.0141286.g001: Data Flow in the DCCT/EDIC Study.The CERC was located at the University of Minnesota, Minneapolis, MN between 1983–2004, and at Wake Forest University, Winston Salem, NC from 2005-present.
Mentions: Following the DCCT, the participants were invited to enroll in the EDIC longitudinal observational follow-up study. Two central coordinating centers, each with distinct functions, support and oversee all of the operational aspects of the EDIC study. The clinical centers are responsible for direct interface with the study participants and data collection, and the central reading units provide technical expertise for the evaluation of laboratory samples, fundus photographs and ECGs (Fig 1). Institutional Review Board (IRB) approval was obtained by each of the individual clinical centers as well as the Data Coordinating Center. Written informed consent was provided by each of the study participants at the clinical centers. Consent for minor participants at study screening and randomization was provided by the minor’s parent or legal guardian, as directed by local institutional guidelines.

Bottom Line: Implementation of multicenter and/or longitudinal studies requires an effective quality assurance program to identify trends, data inconsistencies and process variability of results over time.The results are reviewed by a data quality assurance committee whose function is to identify variances in quality that may impact study results from the central units as well as within and across clinical centers, and to recommend implementation of corrective procedures when necessary.Details of the quality assurance plan across and within the clinical and central reading units are described, and quality outcomes for core measures analyzed by the central reading units (e.g. biochemical samples, fundus photographs, ECGs) are presented.

View Article: PubMed Central - PubMed

Affiliation: Department of Medicine, University of California San Diego, La Jolla, California, United States of America.

ABSTRACT
Implementation of multicenter and/or longitudinal studies requires an effective quality assurance program to identify trends, data inconsistencies and process variability of results over time. The Diabetes Control and Complications Trial (DCCT) and the follow-up Epidemiology of Diabetes Interventions and Complications (EDIC) study represent over 30 years of data collection among a cohort of participants across 27 clinical centers. The quality assurance plan is overseen by the Data Coordinating Center and is implemented across the clinical centers and central reading units. Each central unit incorporates specific DCCT/EDIC quality monitoring activities into their routine quality assurance plan. The results are reviewed by a data quality assurance committee whose function is to identify variances in quality that may impact study results from the central units as well as within and across clinical centers, and to recommend implementation of corrective procedures when necessary. Over the 30-year period, changes to the methods, equipment, or clinical procedures have been required to keep procedures current and ensure continued collection of scientifically valid and clinically relevant results. Pilot testing to compare historic processes with contemporary alternatives is performed and comparability is validated prior to incorporation of new procedures into the study. Details of the quality assurance plan across and within the clinical and central reading units are described, and quality outcomes for core measures analyzed by the central reading units (e.g. biochemical samples, fundus photographs, ECGs) are presented.

No MeSH data available.


Related in: MedlinePlus