Safety Monitoring a. Incident Reporting, as defined in the Project Specifications.
Safety Monitoring. Consultant shall:
a. Ensure that Contractor and Consultant workers receive orientation and safety training;
b. Report any incidents to CIP Safety Manager;
c. Coordinate with CIP Safety Manager for input to contractor submitted PSR; and
d. Review safety as a standing agenda item in construction progress and other meetings.
Safety Monitoring. Vaccine formulations with both adjuvants were generally well tolerated. All animals maintained body weights within reference ranges of normal values for the entire duration of the study. There were also no major changes in behaviour, appetite or stool over the period of observation. Apart from palpable inguinal lymph nodes there were no notable local reactions (oedema, erythema, indurations) in all 18 study animals. Levels of aspartate transaminase in the DiCo/ISA immunisation group as well as alanine transaminase and bilirubin in the AM/ISA group showed slight increases on the days following immunisation but returned to normal levels within a week. There was an increase in creatinine levels a day after immunisation in the DiCo/HT group but these also returned to normal levels within a week. Creatinine levels in the DiCo/ISA group were however above normal values at the start of the study and remained at similar high levels throughout the observation period. Levels of blood iron decreased on the days following immunisation in the DiCo/HT group but also returned to normal levels within a week. All other measured clinical chemistry parameters were within normal reference ranges throughout the 70-day observation period. Of the parameters measured for haematology, increases in neutrophil count (and hence white blood cell count) were observed a day after each immunisation, but these again returned to normal values within a week. All other measured parameters were between normal ranges throughout the study. Generally, local reactions were limited to mild reddening of the injection site area, and these resolved within a few days. One animal in the AM/ISA group however developed stiffness in the upper leg muscle to a degree that limited movement of the left leg. This adverse event was first observed 14 days after the last immunisation (day 70) and had not resolved on day 126. Given this observation, which lasted for more than 56 days, the amount of discomfort to this animal was rated moderate to serious. IgG levels against seven AMA1 alleles and MSP119 at all sampling time points were determined using a harmonized ELISA. The three vaccine formulations induced appreciable levels of antibodies against the tested antigens and titres against all antigens increased in a similar manner and generally peaked on day 70, two weeks after the final vaccine injections were given. IgG titres against the FVO AMA1 allele at all time-points are presented in Figure 1 and day 70 tit...
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. 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. 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 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. 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 issue or class effect that may come to its attention including those from other license partners to the extent Regulus is not precluded by written agreement with the applicable partner from sharing such information with Sanofi. This includes also non clinical safety information.
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. NIAID Extramural Clinical Trial Agreement DMID Protocol # 20-0013 Humanigen - DMID CTA Version 1.0, July 22, 2020
