Appreciating that data is an integral part of any clinical trial, the main aim of data management in FEAST is to ensure that data delivered is credible and accurate and that data management is done in compliance with ICH-GCP standards.
Source documents and Case Report Forms (CRF) are completed and checked for completeness and accuracy at the six trial sites. CRFs are batched and periodically sent to the central data management centre in Kilifi, Kenya for data entry and storage.Serious Adverse Events (SAE) are reported by sending scanned SAE forms by email to Kilifi within 24 hours of onset of the SAE for review and entry to the database.Source documents are retained at the sites, and CRFs are stored in Kilifi in the course of the trial.After the end of the trial, the study documents will be stored in a GCP-compliant archive in Kilifi.
Openclinica,an opensource clinical data management system is used for entry of data (http://www.openclinica.org/). Quality of data entered is ensured through inbuilt logic and range validation checks and a double data entry system to capture data entry errors.Errors detected are consolidated and sent to the sites as queries for resolution.Access to the database is controlled through access level- based accounts with encrpted passwords.An audit trail keeps record of all changes made to the database.
OpenClinica can export data in various formats however for this trial data is exported using the SPSS option which creates both a plain ASCII data file as well as an SPSS syntax file. The SPSS file is then converted to a Stata format data set for analysis. Monthly extracts are done to generate trial progress reports and for regular data cleaning. Data extraction is also done specifically for data required for the Independent Data Monitoring Committee (IDMC).The protocol specifies for interim reviews to be undertaken after there is available data for 300, 600 and 900 study enrolled patients.
The data management team comprises of the trial manager,a data manager and 3 data entry clerks all based in Kilifi,two monitors, one based in Kenya and another in Uganda and 6 study site co-ordinators all based at the respective sites.