Moropeng, M.L., Khatija Ahmed, Maria Manuela Williams, B.L. Mohale, Marlena Gehret, and Joseph Skhosana. "The role of the Quality Control (QC) team in a large Phase 3 HIV prevention clinical trial of Carraguard in Soshanguve, Pretoria, South Africa."

Abstract

BACKGROUND: The Phase 3 clinical trial of Carraguard^TM is a multidisciplinary, multicenter study conducted in Soshanguve and two other sites in South Africa. This trial involves enrolling a large sample size (n=6,639) and requires capture of accurate data for evaluation. Quality control (QC) of data has to be effective and ongoing in order to minimize errors. It is important that data generated is of high quality, accuracy, and validity.

METHODS: A total of 2,213 women have to be enrolled in the study and followed up for a minimum of 12 months. Approximately 4,000 participants have to be screened at our site to achieve this, based on the exclusion/inclusion criteria. Case record forms (CRFs) are completed by trained personnel at every visit according to Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and International Conference on Harmonization (ICH) guidelines. The QC team ensures that all data are accurately entered, completed, legible, dated, and signed and that any inconsistency, inaccuracy, error, or omission is queried and addressed with the responsible staff prior to faxing to central study offices at Population Council, New York, for data entry. The QC team also resolves any queries that are generated by the central study office.

RESULTS: There were 4,141 CRFs captured between March and June 2004, with an average of 828 CRFs per month, compared to 85,828 from July 2004 to November 2005, averaging 5,364 CRFs per month. The QC query rate during the first four months was more than eight queries per 100 CRFs captured compared to less than five queries per 100 CRFs currently. This is despite a 7-fold increase in the volume of CRFs generated per month.

CONCLUSION: Since the employment of the QC team in July 2004 there has been a marked improvement on legibility, decrease in omissions, and general consistencies of data faxed. Utilizing the QC team has markedly improved the quality of data submitted and decreased the number of queries from central study office. Capturing of accurate and good-quality data in a large, multidisciplinary clinical trial involves ongoing staff training and compliance to GCP/GLP and ICH guidelines.

Microbicides 2006

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This page updated 3 April 2006

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