Experiences with the Management of Data of iPrEx in Lima:
or How to be part of the Data Management Center
and not Die Trying…
The iPrEx study started at INMENSA back in June of 2007. Since then, the DCT has QCed (data management lingo for performing “quality control”) 23,324 screening and enrollment case report forms (CRF.) Follow-up monthly visits have generated the revision of 17,000 CRFs and 500 clinical charts for about 34 visits for each participant. In all, the team has checked 21,094 Informed Consent Forms (ICFs) for consistency and 100% of the data have been QCed. The list of forms and tools that data managers use at the site level give you some idea of how carefully every participant record is scrutinized to ensure that all data in the Global iPrEx study are completely accurate. (They may also make you glad that you’re not a data manager!) At the site level, data managers use these tools to guarantee data quality control:
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Internal QA / QC, which are conducted after each study visit and in the screening and enrollment phase. Chart review tools: in- house developed tools to conduct QC/QA activities in 100% of CRFs and medical charts. Error tracking logs, to identify and track any CRFs errors. Monitoring reports: generated by the study sponsor. Others: datafax and transmission reports and Queries and QC resolutions reports.
In addition, the data management team continually reviews the following for all Global iPrEx participants:
•• •• •• • •• •• ••
Informed consent form and process Participant education Test of understanding of the protocol Eligibility criteria HIV prevention counseling Lab results follow up and procedures Concomitant medications, vaccines, prohibited medications Missed visits and follow-up Protocol endpoint verification AE / SAE reporting follow-up Adherence report Study product administration / Dosing Verification of consistency between pharmacy records and clinical chart
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Correction procedures:
The team manages the QC and QA, CRF transcription and CRF correction procedures
Data cleaning To prepare for the primary analysis of iPrEx data (the analysis of all data collected through May 1, 2010) the team has been working for the last three months cleaning the data and solving queries in a coordinated way with DF/Net and the study statistician. With all these numbers moving around, the quality of communication and collaboration between the data management team and the clinic staff is particularly important to ensuring that everything is done and checked and rechecked for complete accuracy. We are fortunate to all work together in a very collaborative and participative environment that has as its top priority ensuring that all of the data produced in the iPrEx study is the best it can be. The Data Management Center at INMENSA is like a fine timepiece, working together to improve the health and wellbeing of study participants through research, prevention and treatment of disease. And thanks to their outstanding efforts, the Global iPrEx clock keeps ticking! iPrEx UPDATE • 3rd QUARTER 2010 • NUMBER 5
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