Eliciting Adverse Event Information Sample Clauses

Eliciting Adverse Event Information. The investigator is to report all directly observed adverse events and all adverse events spontaneously reported by the trial subject. In addition, trial subjects should be *** Certain adverse events require prompt and specific action by the investigator in any clinical trial. The following sections describe additional requirements to ensure ***.

Eliciting Adverse Event Information. At every study visit, patients must be asked a standard, non-directed question, such as, “How have you been feeling since your last visit?” to elicit any medically related changes in their well-being. They may also be asked if they have been hospitalized, had any accidents, used any new medications, or changed concomitant medication regimens (including prescription drugs, over-the-counter medications, vitamins, herbal products, and minerals). Responses must be documented in the source documents. In addition to patient observations, AEs must be documented for any clinically significant diagnosis resulting from abnormal laboratory test values, physical examination findings, or ECG abnormalities, or from other documents that are relevant to patient safety.

Eliciting Adverse Event Information. The investigator is to report all directly observed adverse events and all adverse events spontaneously reported by the trial subject. In addition, trial subjects should be *** *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. Certain adverse events require prompt and specific action by the investigator in any clinical trial. The following sections describe additional requirements to ensure ***.