Aim: To develop and implement a scalable, GCP-compliant, robust data management/ICT infrastructure suitable for resource-poor settings in SSA.
WP3 are continuing to provide support for the ALERRT CCP study and will provide additional support for the nested study, including collection of additional variables on steroid use and long-term follow up.
The WP3 team have released the CDISC mapping of the FISSA study Case Report Forms (CRFs) for public download.
A news item disseminating this new resource has been issued across the ALERRT partners and wider scientific community. This tool will serve as a guide for FISSA sub-studies and for other future studies on emerging infections to support data quality and data standards for better research. The tool is available in English and French.
Following the initial library of Standard Operating Procedures (SOPs) developed in Year 1, it was deemed necessary to develop additional SOPs to cover the following critical areas: Remote IT Support, Site Database Deployment, Site Systems Upgrade, and Change Management.
The REDCap Central Server that hosts the central databases of all studies has undergone complete validation and the final validation certificate was shared in September 2020. The WP3 team are hosting additional projects on the server as well as providing data management and IT support to them and these projects include the Africa CCP and the Healthcare Worker Survey.
The first data transfers using the Data Transfer Tool (DTT) commenced in May 2020, by the Cote d’Ivoire and Gambia FISSA Study sites.
The WP3 data manager has worked with the Senegal and Cameroon teams in customizing and deploying the HCWS REDCap database for them as well as providing training to their data collection staff.
The WP3 team have taken over responsibility of the XML files for the REDCap databases for both the Africa CCP Study and the Healthcare Worker Survey (HCWS).
Training of Trainers on the ALERRT DM/IT Platform was conducted successfully in February 2020. A suite of training materials was developed and shared with all sites. These included user guides of the various systems and tools, SOPs, presentations, and most importantly the Moodle hosted on an e-learning platform. All training sections were video-recorded and shared with WP5 for potential conversion to study-specific eLearning material.
Learning management system: the content has been finalised and WP3 currently in
contact with Frank Kagoro to discuss the arrangements on the TGHN platform. To be
ready by early 2023.
Supporting the nested study and its central data manager, Serge Dhano, with paper
and electronic CRF design.
MRC Gambia involved in discussions on the Long COVID database with Joe Bonney.
Databases to be set for the Wellcome WP2 and WP3.
Peter supporting WHO Uganda and Ministry of Health on writing therapeutic trials
protocols for Ebola but there is not much trial management capacity. PH has reached
out to Bai and Harry to help with the data management side. It would be good to bring
capacity within the ALERRT network.
The FISSA study is a prospective study of Fever in Subsaharan Africa conducted by the ALERRT network. The FISSA study case record form (CRF) is developed and implemented by the FISSA Principal Investigators, the study team and the FISSA Data Management Team.
CDISC, the Clinical Data Interchange Standards Consortium produces internationally recognised standards for the labelling, formatting and structuring clinical data. CDISC produces a number of standards, one of which is the CDASH standard. CDASH is used to standardise the collection of data.
The CDASH Mapping for the ALERRT FISSA Study CRF has been prepared by the ALERRT Data Management team and includes the FISSA study data dictionary in English and French, with CDASH mapping.
Development of databases that use the CDASH standards enables the data to be collected using robust structure s and terminologies. This improves data quality and interoperability, facilitating the aggregation and sharing of data.
MRC Unit The Gambia at LSHTM hosted a training of 2 regional trainers from the 13-15th of November. The training was targeted to the FISSA Study Central Data Manager based in Cote D’Ivoire and a supporting Data Manager based in Uganda. The purpose of the training was to bring the trainers up to speed on the ALERRT Data Management and ICT Platform. The platform and the training covered the following modules:
The training was delivered by key members of the WP3 team: