Files stored in this repository correspond to the data extracted from the CRDe RedCAP used in this study. The file 'DOTIG_DATA_NoAA_LABELS_2023-10-31' corresponds to the data collected during the study, and the file 'DOTIG_DATA_AA_LABELS_2023-10-31' corresponds to the adverse events recorded during the study. Additionally, there is one more file which is the recoding of adverse events to "MEDDRA Terms (PT) vs 25.1" and "SOC".
IBSAL uses the REDCap system for database creation. A detailed description of the information to be captured in the database is documented in the "DOTID_PGD_Data Dictionary Codebook" document. The structure of this data in the CRDe is described in the "DOTIG_PGD_Annotated CRDe document". The Annotated CRDe details the names of input objects in the CRDe with the name, format, and type of variables that will be used during the data entry process. The database must capture all the elements included in the "DOTIG_PGD_Variable List" document.
The data management throughout the study is documented in the document DOTIG_PGD_Data Management Report.