Pregnancy in the Clinical Study. Women of childbearing potential or women who are pregnant at the time of study entry are not excluded from participation. Pregnancy should be included in the Medical History section of the eCRF when a pregnant woman enters the study or if a woman becomes pregnant during the study. Pregnancy is not reportable as an AE; however, complications may be reportable and will be decided on a case–by-case basis.
Appears in 6 contracts
Samples: Investigator Agreement, Investigator Agreement, Investigator Agreement
Pregnancy in the Clinical Study. Women of childbearing potential or women who are pregnant at the time of study entry are not excluded from participation. Pregnancy should be included in the Medical History corresponding section of the eCRF (i.e., Pregnancy CRF) when a pregnant woman enters the study or if a woman becomes pregnant during the study. Pregnancy is not reportable as an AE; however, complications may be reportable and will be decided on a case–-by-case basis.
Appears in 1 contract
Samples: Investigator Agreement
Pregnancy in the Clinical Study. Women of childbearing potential or women who are pregnant at the time of study entry are not excluded from participation. Pregnancy should be included in the Medical History section of the eCRF when a pregnant woman enters the study or if a woman becomes pregnant during the study. Pregnancy is not reportable as an AE; however, complications may be reportable and will be decided on a case–-by-case basis.
Appears in 1 contract
Samples: Investigator Agreement
Pregnancy in the Clinical Study. Women of childbearing potential or women who are pregnant at the time of study entry are not excluded from participation. Pregnancy should be included in the Medical History section of the Pregnancy eCRF in EDC when a pregnant woman enters the study or if a woman becomes pregnant during the study. Pregnancy is not reportable as an AE; however, complications may be reportable and will be decided on a case–by-case basis.
Appears in 1 contract
Samples: Investigator Agreement
Pregnancy in the Clinical Study. Women of childbearing potential or women who are pregnant at the time of study entry are not excluded from participation. Pregnancy should be included in the Medical History section of the eCRF when a pregnant woman enters the study or if a woman becomes pregnant during the study. Pregnancy is not reportable as an AE; however, complications may be reportable and will be decided on a case–-by-case basisbasis .An Alcon form will be utilized to capture all pregnancy- related information until birth of the child.
Appears in 1 contract
Samples: Investigator Agreement
Pregnancy in the Clinical Study. Women of childbearing potential or women who are pregnant at the time of study entry are not excluded from participation. Pregnancy should be included in the Medical History section of the appropriate eCRF when a pregnant woman enters the study or if a woman becomes pregnant during the study. Pregnancy is not reportable as an AE; however, complications may be reportable and will be decided on a case–by-case basis.
Appears in 1 contract
Samples: Investigator Agreement
Pregnancy in the Clinical Study. Women of childbearing potential or women who are pregnant at the time of study entry are not excluded from participation. Pregnancy should be included in the Medical History section of the Pregnancy eCRF form in EDC when a pregnant woman enters the study or if a woman becomes pregnant during the study. Pregnancy is not reportable as an AE; however, complications may be reportable and will be decided on a case–by-case basis.
Appears in 1 contract
Samples: Investigator Agreement
Pregnancy in the Clinical Study. Women of childbearing potential or women who are pregnant at the time of study entry are not excluded from participation. Pregnancy should be included in the Medical History section of the eCRF when a pregnant woman enters the study or if a woman becomes pregnant during the study. Pregnancy is not reportable as an AE; however, complications may be reportable and will be decided on a case–by-case basis.
Appears in 1 contract
Samples: Investigator Agreement