When the data manager has ensured the quality and integrity of the data, he/she passes on the prepared, cleaned data set to the relevant statistician and investigator for analysis.
Data archive: During 2007 a policy on data archiving was approved by the Senior Management. This policy covers both electronic and paper archives. Forms that are still required are kept in an archive in Entebbe, while forms and questionnaires that are no longer needed for regular data management tasks are transferred to the long term storage space in Kyamulibwa. In addition to such long term storage, Kyamulibwa has its own archive as does the Masaka Research Office. A full-time archivist was appointed in Entebbe in 2008, while one of the DEOs in Kyamulibwa has responsibility for the archive there.
In addition to the paper archive, the Stats section maintains an electronic archive of study data as well as metadata (definitions, supporting data, analysis files, papers and other important information) for each study. The archivist has the responsibility of ensuring that all studies have adequate documentation, as well as the preservation of electronic data.
Database creation:
The ARROW database: Two programmers in the Statistics section were commissioned to produce a new database for the collection of data in the pharmacy for the ARROW study. This database was produced in SQL and enables the same data to be collected in all sites of this multi-centre trial. The success in creating the ARROW pharmacy database has encouraged the section to develop the capability to provide GCP compliant databases for future clinical trials, such as those that may form part of the Good Health for Women Project. more
