Study Management

Define Study in EDC - Unique Protocol ID: study identifier, use a code which we use to identify the study; first 8 characters (ignoring spaces) of study unique identifier will be prefixed with ‘S_’ used to generate Study OID - Site Unique Protocol ID: site study identifier, use RPB partner site unique identifier as prefix: e.g ‘DD-’ + parent study Unique Protocol ID - Define a short (2 character), unique trial EDC code (e.g. ‘AA’, ‘XN’) and store it as first element in Secondary IDs field, this code is used in RPB naming conventions; optionally use small ‘r’ or ‘p’ to denote retrospective or prospective basis of the study in the code (e.g. ‘HNp’, ‘HNr’); check the availability of the code in CTMS - Create CRFs (at least one [[FormDefinition]] need to be specified), use RPB naming conventions - Create Event Definitions (at least one [[StudyEventDefinition]] need to be specified), use RPB naming conventions - Set Study Status: Available

Define Study in CTMS and link it to EDC - Create RPB study (Administration->Studiesmanagement->Studies) and link (parent) study defined in EDC - Edit CTMS details for RPB study (CTMS->Studies) - Specify study tags (EDC Code tag e.g. ‘AA’, to make it easily possible to check availability of the code for new trials) - Specify study tumour entities - Create eCRF field annotations (Administration->Studienmanagement->eCRF Field Annotations)