2 The sign date is missing. However, EPOCH can be assigned based on VISIT 1 since the protocol defines the PERIOD 1 EPOCH as Days 1 14. – 10 The unplanned vital sign date is completely missing. Neither the date nor the 2 and 3 visit can be used to assign EPOCH. Therefore, EPOCH will be assigned as null. 1 1 The chronology of the partial AE start date falls in the RUN-IN EPOCH. 2 and 4 3 1, 2, 3, 4, The chronology of the partial AE start date indicates that the observation could 2 and 5 and 5 be associated with multiple epochs. Therefore, EPOCH could be assigned to a treatment EPOCH to be most conservative. However, it is important to consult with the review division to determine the best way to approach this situation. 4 5 and 6 The chronology of the partial AE start date indicates that the observation could 2 and 6 be associated with either a treatment or follow-up EPOCH. Therefore, EPOCH could be assigned to the treatment phase to be most conservative. However, it is important to consult with the review division to determine the best way to approach this situation. ** Planned EPOCHs for this Use Case are: VS (Vital Signs) Row USUBJID VSTESTCD VSTEST VSORRES VSORRESU VISITNUM VISIT 1 001-1002 TEMP Temperature 34.7 C 1 Screening 2013-05-01 SCREENING Period 1 2 001-1002 TEMP Temperature 36.2 C 2 Day 1 PERIOD 1
2 The sign date is missing. However, EPOCH can be assigned based on VISIT since the protocol defines the PERIOD 1 EPOCH as Days 1 – 14. 1 10 The unplanned vital sign date is completely missing. Neither the date nor the visit can be used to assign EPOCH. Therefore, EPOCH will be assigned as null. 2 and 3 1 1 The chronology of the partial AE start date falls in the RUN-IN EPOCH. 2 and 4 3 1, 2, 3, 4, and 5 The chronology of the partial AE start date indicates that the observation could be associated with multiple epochs. Therefore, EPOCH could be assigned to a treatment EPOCH to be most conservative. However, it is important to consult with the review division to determine the best way to approach this situation. 2 and 5 4 5 and 6 The chronology of the partial AE start date indicates that the observation could be associated with either a treatment or follow-up EPOCH. Therefore, EPOCH could be assigned to the treatment phase to be most conservative. However, it is important to consult with the review division to determine the best way to approach this situation. 2 and 6 ** Planned EPOCHs for this Use Case are: VS (Vital Signs) Row USUBJID VSTESTCD VSTEST VSORRES VSORRESU VISITNUM VISIT 1 001-1002 TEMP Temperature 34.7 C 1 Screening 2013-05-01 SCREENING 2 001-1002 TEMP Temperature 36.2 C 2 Period 1 Day 1 PERIOD 1