Data management
adverse drug reactions
ADVERSE EVENTS, ADVERSE DRUG REACTIONS
Data from the implementation research mainly relating to IPTsc coverage and adverse drug reactions were collected through special paper forms (drug accountability and dispensing forms). These forms were crosschecked prior to their dispatch to wards and council level for compilation. The head teacher signed and stamped their final forms before sending them to WEO, who also checked before completing compilation of a ward report. All these forms were then sent to the council, where the study team entered the information into the Open Data Kit (ODK) toolkit. ADR reporting forms were directly sent to TMDA (or collected at site by TMDA team) and then entered into the TMDA pharmacovigilance platform via an account created for this study in the TMDA-WHO Vigflow for Pharmacovigilance (For the effectiveness evaluation portion, data from baseline household surveys, routine clinical evaluation visits and adverse events were entered directly into ODK applications installed on tablets. Spatial data (point coordinates for schools and households) were collected during household and school visits using the GPS capabilities of ODK. To ensure data accuracy of data, all sections (demographic, clinical and laboratory) were completed by trained and qualified personnel. Electronic forms were coded, and filters and skip patterns were set to minimize chances of errors. The filters were used to restrict entry of unwanted or incorrect information into the database. At the central point, data managers ran queries to check the correctness of data entered. Where errors flagged, queries were sent to the field manager for appropriate actions. Paper-based data (from laboratory results) were verified and double entered into a database developed in Microsoft Access 2010 (Redmond, WA, USA), while consistence checks and analyses were done using STATA software version 15.0 (StataCorp LP, TX, USA). Quality control and data assurance of the data were maintained at all stages following site standard operating procedures (SOPs).All responsible personnel had unique codes for data entry, and access to the database was extended as a privilege by the system administrator. Data managers had broad database access while others had restricted access depending on roles assigned. For instance, data entrants could enter new data but not change extant entries, while field managers had the ability to respond to queries raised by the data manager. Any changes done to the database were documented.Back-ups of data were done on a daily basis onto external hard disks that were stored in a secured place separate from the building hosting data management section. A training programme and procedures were implemented before the data systems were fully deployed. Ongoing management including re-training of the system was also observed throughout the lifetime of the project. An enormous amount of data has been generated from this study, and these will benefit different stakeholders in the future, including university students. Such students will be invited to use the data in line with policies on data sharing, including the Data Transfer Agreement (DTA) [