Adverse Event Collection. Safety Assessment Assess and record any AEs that are observed or reported, including those associated with changes in concomitant medication dosing since the previous visit. Requirements for reporting AEs in the study can be found in Section 11.
Appears in 3 contracts
Samples: Investigator Agreement, Investigator Agreement, Investigator Agreement
Adverse Event Collection. Safety Assessment Assess and record any AEs that are observed or reported, including those associated with changes in concomitant medication dosing since the previous visit. Requirements for reporting AEs in the study can be found in Section 11.
Appears in 1 contract
Samples: Investigator Agreement
Adverse Event Collection. Safety Assessment Assess and record any AEs adverse events that are observed or reportedreported since the previous visit, including those associated with changes in concomitant medication dosing since the previous visit. Requirements for reporting AEs in the study can subject source documents. See Section 11 for further details regarding AE collection and reporting. Note: AEs must be found in Section 11recorded for all enrolled subjects from the time of signature of informed consent, regardless of subject enrollment status (screen failure or randomized).
Appears in 1 contract
Samples: Investigator Agreement