Clinical data management [10] Critical: Major: CRF and trial specific eCRF design/build, functionality, source in CRF, (independent copy on site etc.) Diaries and e-PRO Data entry, verification/validation (edit checks), self-evident corrections, audit trails Data handling/transfers, coding COMPLETE Data reconciliation (e.g. with lab data, PV data) TO Database lock Un-blinding Other (specify) OPTIONAL Source data review/verification [11] Critical: Major: Safety & efficacy data (reliability of data, protocol compliance) SDV performed for subject numbers (enter details): TO Other (specify) COMPLETE OPTIONAL Clinical trial monitoring [12] Critical: Major: Compliance with monitoring plan/procedures Reporting of monitoring visits (assessment/routine/close out) TO Issue resolution and escalation of issues Central monitoring activities Other (specify) COMPLETE OPTIONAL
Clinical data management [10] Critical: Major: OPTIONAL TO COMPLETE CRF and trial specific eCRF design/build, functionality, source in CRF, (independent copy on site etc.) Diaries and e-PRO Data entry, verification/validation (edit checks), self-evident corrections, audit trails Data handling/transfers, coding Data reconciliation (e.g. with lab data, PV data) Database lock Un-blinding Other (specify) Source data review/verification [11] Critical: Major: OPTIONAL TO COMPLETE Safety & efficacy data (reliability of data, protocol compliance) SDV performed for subject numbers (enter details): Other (specify) Clinical trial monitoring [12] Critical: Major: OPTIONAL TO COMPLETE Compliance with monitoring plan/procedures Reporting of monitoring visits (assessment/routine/close out) Issue resolution and escalation of issues Central monitoring activities Other (specify)
WC500146896.docx