Examples of Serious Adverse Experience in a sentence
Providing to the Investigator the most up-to-date editions of the Clinical Investigator’s Brochure (for the investigational product), the protocol, Serious Adverse Experience forms, and a full set of Case Report Forms for each subject entered into the study to document the study evaluation parameters.
A Serious Adverse Experience or Event (SAE) is any AE that occurring at any dose results in any of the following outcomes: death, life-threatening adverse toxicity experience, inpatient hospitalization or prolongation of existing hospitalization (excluding hospitalization for elective procedures or transfusions), a persistent or significant disability/incapacity, or a congenital anomaly/birth defect.
Providing to the Investigator the most up-to-date editions of the Clinical Investigator's Brochure (for the investigational product), the protocol, Serious Adverse Experience forms, and a full set of Case Report Forms for each subject entered into the study to document the study evaluation parameters.
Furthermore, upon Sponsor's reasonable request, DCR shall promptly investigate any such Serious Adverse Experience and shall submit follow-up reports of new information in a timely manner.
Any and all losses and administrators, legal representatives or successors, as financial charges on account of such liquidation / closing- the case may be.