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. 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. 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. Consultant shall:
Safety Monitoring a. Incident Reporting, as defined in the Project Specifications.
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. In an effort to maximize understanding of the safety profile and pharmacokinetics of Regulus compounds, 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
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. The Parties, through the JSC, shall discuss and establish standard operating procedures (SOPs) for exchange of any and all information on serious Adverse Drug Events as defined by any regulatory Governmental Authority (hereinafter referred to as “ADE”) and any other ADE in connection with any use of the Compound and/or the Products which the Parties are obligated to report to any regulatory authorities or Governmental Authority in accordance with applicable regulations or requirements. Such procedures shall be established at such time as considered relevant by the Parties, but in any event shall be established so as to enable the Company and Fxxxxx to comply with all regulatory and legal requirements and the terms of any regulatory approval. The Company and Fxxxxx shall promptly exchange any and all data or other information which is either acquired or otherwise becomes known to them regarding ADEs associated with or related to the use of the Compound or the Products.
Safety Monitoring. The Studies will be monitored by an Institution designated Study Monitoring Committee (SMC) as described in the Protocols. The Institution will notify the Company in advance of any SMC review. Institution will provide recommendations derived from the SMC to the Company in a timely manner.
