Adverse Event Collection. Safety Assessment
Adverse Event Collection. Patients will be observed for general appearance, presence of illness or injury, or signs indicative of a concurrent illness as indicated in Table 4. Patients must be instructed to volunteer any information regarding AEs on or after the first dose of study drug or query the patients with an open question regarding any AEs they may be experiencing (e.g., “How have you been feeling since your last visit?”). Any findings are to be documented. Patients must 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.
Adverse Event Collection. 1.1 Optime shall collect and document any adverse events (“AE”s) associated with the use of any Corcept Product on Corcept’s Adverse Drug Experience Report Form (“ADE Form”).
1.2 Optime shall complete the ADE Form with all known AE details. At a minimum, the ADE Form should include an Optime’s date of AE awareness, identifiable patient, identifiable reporter, suspect product information, and AE description.
Adverse Event Collection. All Adverse Events occurring during a clinical trial of the Licensed Product sponsored by Simcere shall be collected in a customary manner, including without limitation:
(a) verbatim description;
(b) onset and duration;
(c) treatment;
(d) severity, according to NCI Common Terminology Criteria for Adverse Events;
(e) relatedness, per investigator assessment; and
(f) outcome, and action taken in response to study drug Simcere must report this data to Xxxxx in aggregate, de-identified form at the conclusion of the clinical trial, or at any interim analysis of safety data.
Adverse Event Collection. The PI will be responsible for reviewing and confirming all AEs and XXXx collected during the study. The PI will collect AEs during study visits after enrollment. All SAEs will be collected for the duration of the protocol. All SAEs which occur during the course of the trial, whether considered to be associated with the study drug or not, have to be reported within 24 hours of the PI’s awareness of their occurrence. All SAE reports should be faxed to the Sponsor. A fax number will be provided to the site in separate site-specific instruction for SAE reporting. In addition to the fax, the PI, or designee should call the CRA during normal working hours and verbally inform the CRA of the SAE. During off business hours or if medical advice is needed immediately please call the Sponsor Medical Monitor. An SAE reporting instruction with all contact numbers will be provided to the site prior to study start. MAPS Office Telephone: 000-000-0000, ext. 104 Fax: 000-000-0000
Adverse Event Collection. The study physician will be responsible for reviewing and confirming all AEs and XXXx collected during the study. The therapists will collect AEs during study visits after enrollment. All SAEs will be collected for the duration of the protocol. All SAEs which occur during the course of the trial, whether considered to be associated with the study drug or not, have to be reported within 24 hours of the investigator’s awareness of their occurrence. All SAE reports should be faxed to the Sponsor. A fax number will be provided to the site in separate site-specific instruction for SAE reporting. In addition to the fax, the study physician, Clinical Investigator (CI) or designee should call the CRA during normal working hours and verbally inform the CRA of the SAE. During off business hours or if medical advice is needed immediately please call the Sponsor Medical Monitor. An SAE reporting instruction with all contact numbers will be provided to the site prior to study start. Xxxxxxx X Xxxxxxxxx Study Monitor contact information will be provided in a separate contact list. Adverse events that will be collected for the duration of the protocol are: • All SAEs will be collected through subject termination. • All AEs and spontaneously reported reactions will be collected on the day of drug administration and for seven days after each experimental session. • Events requiring medical attention will be collected from enrollment through the subject’s last 2-month follow up. • Events related to planned treatments or physician visits for baseline conditions collected in the Medical History will not be collected unless there is an exacerbation of the condition. • Any Adverse Event leading to withdrawal from the protocol will be collected throughout the study. • All AEs related to changes in psychiatric status will be collected throughout the study. A Memory aid card will be provided to the subject on the last visit prior to the 12-month Follow-up to record information on medications taken to treat SAEs, AEs leading to withdrawal and psychiatric AEs during the follow-up period between the end of Stage 1/Stage 2 and the 12-month follow-up evaluation. The memory aid card will not be collected, but information from the card will be used to aid the subjects in providing information to the investigator. This information may be collected by phone.
