Safety Monitoring. In accordance with NIH guidelines the Company and the NIAID agree that the following type(s) of safety monitoring is (are) necessary and appropriate for this Clinical Trial:
Safety Monitoring. Consultant shall:
Safety Monitoring a. Incident Reporting, as defined in the Project Specifications.
Safety Monitoring. 4. The WELCOMING COUNSELOR must make a diligent and reasonable effort to ensure regular telephone contact between the parent and a child or youth, unless that contact is deemed to be detrimental to the child or youth. The initial telephone contact must take place as soon as practicable, but no later than five hours after the child arrives at The CENTER.
Safety Monitoring. Zymeworks shall conduct all post-marketing safety surveillance required by a Regulatory Authority in the Territory for Licensed Products in connection with the Zymeworks Ongoing Studies, at Jazz’s cost and expense in accordance with a budget mutually agreed to by the Parties. Zymeworks shall provide the results of any such post-marketing safety surveillance to Jazz for Jazz’s submission of such results to the applicable Regulatory Authority. Otherwise, Jazz shall be responsible for all post-marketing safety surveillance and reporting required in the Territory for Licensed Products, and such responsibility shall be included in the SDEA Agreement.
Safety Monitoring. In accordance with NIH guidelines, the Company and the NHLBI agree that the following type(s) of safety monitoring is (are) necessary and appropriate for this Clinical Trial: DSMB. If a DSMB is constituted or is in place for the Clinical Trial, the NHLBI or CTSN DCC will notify the Company in advance of any DSMB review. The Company may participate in and will receive the open session reports of the DSMB. The recommendations derived from the closed sessions, redacted to maintain blinding of the Company to control data, will also be communicated to the Company.
Safety Monitoring. In an effort to maximize understanding of the safety profile and pharmacokinetics of Regulus compounds, after IND Approval, Sanofi will cooperate with Regulus and forward safety information to Regulus designated contact persons. This includes transmission of serious adverse events collected from Sanofi sponsored studies in a timely fashion as agreed in the SDEA. Vice versa Regulus shall promptly inform Sanofi on any
Safety Monitoring. 23 8.1. Description of study parameters 23 8.2. Recording and reporting Safety Parameters 24
Safety Monitoring. NIDDK appointed DSMB will monitor the data for safety and efficacy for outcomes such as hepatotoxicity, pregnancy, and any other outcomes or events identified as safety-related. A member of the NIDDK DSMB will serve as a liaison to Intercept’s Data Safety Monitoring Committee meetings and participate as necessary to ensure safety surveillance across all of Intercept’s studies.
Safety Monitoring. In accordance with NIH guidelines the Company and the NIAID agree that the following type(s) of safety monitoring is (are) necessary and appropriate for this Clinical Trial: Data and Safety Monitoring Board (DSMB). If a DSMB is constituted for the Clinical Trial, the NIAID will notify the Company in advance of any DSMB review. The Company may participate in and will receive the open session reports of the DSMB. The recommendations derived from the closed sessions will also be communicated to the Company. Prior to the Completion of the Clinical Trial, all data and reports distributed for DSMB review will be used only for the purposes of the DSMB meeting and will be held in confidence. 24 Apr 2018 CTA Template Version 9.0 DMID CTA Template for DMID-Held IND NIAID Extramural Clinical Trial Agreement DMID Protocol # 20-0013 Humanigen - DMID CTA Version 1.0, July 22, 2020
