A CRF collected pregnancy event information; however, no pregnancy events were reported. Annotated CRFs Collected fields that have not been tabulated have been annotated as LDCP, “NOT SUBMITTED”. Inc. collects certain data elements (e.g. prompt questions) to facilitate certain operational processes including data cleaning and dynamically creating additional forms in the electronic data capture (eDC) system. All fields that have been annotated as criteria. “NOT SUBMITTED” meet these SDTM Subject Domains Related Using Observation Other Dataset Dataset Label RELREC Class – Efficacy Safety SUPP- AE Adverse Events X RE Events – X X Interventions CO Comments X Special Purpose – DM Demographics X Special Purpose – X Events X Interventions X X X Findings MH Medical History X Events – QS Questionnaires X X Findings – RE Respiratory System Findings X X X AE Findings – SE Subject Elements X Special Purpose – SV Subject Visits X Special Purpose – X Findings CM Concomitant Medications – The start date for historical corticosteroids was not reported for 37 subjects. As a result, validation rule errors are to be expected.
A CRF collected pregnancy event information; however, no pregnancy events were reported. Annotated CRFs Collected fields that have not been tabulated have been annotated as “NOT SUBMITTED”. LDCP, Inc. collects certain data elements (e.g. prompt questions) to facilitate certain operational processes including data cleaning and dynamically creating additional forms in the electronic data capture (eDC) system. All fields that have been annotated as “NOT SUBMITTED” meet these criteria. SDTM Subject Domains Dataset – Dataset Label Efficacy Safety Other SUPP- Related Using RELREC Observation Class AE – Adverse Events X RE Events X X Interventions CO – Comments X Special Purpose DM – Demographics X Special Purpose X Events X Interventions X X X Findings MH – Medical History X Events QS – Questionnaires X X Findings RE – Respiratory System Findings X X X AE Findings SE – Subject Elements X Special Purpose SV – Subject Visits X Special Purpose X Findings CM – Concomitant Medications The start date for historical corticosteroids was not reported for 37 subjects. As a result, validation rule errors are to be expected.