Study Termination. Failure in biochemical activity is defined when the measured value at a certain time point deviates [*****]% from the original value measured at time (t=O.)Failure of [*****]% of the kits with respect to the testing criteria mentioned above, will lead to the study termination and the prior point will become the shelf life. Centogene and Shire upon review and agreement of the results will accept the limitations supported by these studies. [*****]
Study Termination. This study may be terminated at any time by the Sponsor if there is sufficient reasonable cause. Circumstances that may warrant termination include, but are not limited to: · Determination of unexpected, significant, or unacceptable risk to subjects. · Failure of enrollment · Administrative reasons · Plans to modify, suspend or discontinue the development of the study drug. In addition, individual study sites may be terminated from study participation for reasons including, but not limited to the following: · Failure to enter subjects at an acceptable rate. · Insufficient adherence to protocol requirements. · Incomplete and/or non-evaluable data. In all cases, the terminating parties will provide written notification documenting the reason for study termination to all the relevant parties. Should the study or an individual site be prematurely closed, all study materials (completed, partially completed, and blank CRFs, study drug, etc.) must be returned to the Sponsor (or its designee).
Study Termination. This study may be terminated at any time, if in the opinion of the Sponsor, the Investigator or the DSMB, there is sufficient reasonable cause. Circumstances that may warrant termination include, but are not limited to: · Determination of unexpected, significant, or unacceptable risk to subjects. · Failure of enrollment · Administrative reasons · Plans to modify, suspend or discontinue the development of the study drug. In addition, individual study sites may be terminated from study participation for reasons including, but not limited to the following: · Failure to enter subjects at an acceptable rate. · Insufficient adherence to protocol requirements. · Incomplete and/or non-evaluable data. In all cases, the terminating parties will provide written notification documenting the reason for study termination to all the relevant parties. Should the study or an individual site be prematurely closed, all study materials (completed, partially completed, and blank CRFs, study drug, etc) must be returned to the Sponsor (or its designee).
Study Termination. If the Sponsor, an Investigator, or Clinical Study Monitor discovers conditions arising during the study that indicate that the clinical investigation should be halted due to an unacceptable patient risk, the study must be terminated after appropriate consultation between ImmunoGen and the Investigators. In addition, a decision on the part of ImmunoGen to suspend or discontinue development of the study drug may be made at any time. Within 15 days of premature closure, ImmunoGen must notify the competent authorities and IECs/IRBs of any member state where the study is being conducted, providing the reasons for study closure.
Study Termination. This Work Order shall be effective upon full execution by the parties (the Effective Date), and shall terminate on the later of: i) one (1) year from the Effective Date, or ii) the date of Study database lock if there is subject enrolment under this Work Order in the Study, or iii) the date of completion of all of the obligations of the parties hereunder, unless terminated earlier pursuant to the terms of the Master Pharmacy Agreement or this Work Order.
Study Termination. (a) Institution hereby acknowledges and agrees that Sponsor and CRO reserve the right to terminate the participation of Institution, Investigator or any subject in the Study or the Study itself at any time and for any or no reason. If Institution or Investigator’s participation in the Study or the Study itself is terminated, Institution shall ensure that Investigator ceases to enrol subjects, ceases treatment with the Study Drug(s) to the extent medically permissible, and shall return or dispose of all Study Drug(s) in accordance with instructions provided by CRO and regulatory requirements. (b) In the event of termination, payments will be made for all services required by the Protocol that have been performed and any reasonable non- cancelable costs which are incurred by Investigator or Institution in connection with the Study as required under the Protocol. If any advance or other payments 15.
Study Termination. (a) The Institution and the Investigator hereby acknowledge that the Sponsor and CRO reserve the right to terminate the participation of the Investigator or any subject in the Study or the Study itself at any time and for any or no reason. If the Investigator’s participation in the Study or the Study itself is terminated, the Investigator agrees to cease enrolling subjects, cease treatment with the Study Drug(s) to the extent medically permissible, and return or dispose of all the Study Drug(s) in accordance with instructions provided by CRO and regulatory requirements.
Study Termination. (a) The Institution and the Investigator hereby acknowledge that the Sponsor and CRO reserve the right to terminate the participation of the Investigator or any subject in the Study or the Study itself at any time and for any or no reason. If the Investigator’s participation in the Study or the Study itself is terminated, the Investigator agrees to cease enrolling subjects, cease treatment with the Study Drug(s) to the extent medically permissible, and return or dispose of all the Study Drug(s) in accordance with instructions provided by CRO and regulatory requirements. (b) In the event of termination, payments will be made for all services required by the Protocol that have been performed up to the effective date of termination and any reasonable non- cancelable costs which were incurred by the Investigator in connection with the Study as required under the Protocol and contemplated in the Budget. If any advance or other payments exceed the amount owed for services performed under the Protocol, the Institution shall promptly return the excess balance to 15.
Study Termination. Although SIGA has every intention of completing the study, they reserve the right to discontinue it at any time for clinical or administrative reasons. An initiative for closure of the clinical investigative site or termination of the study can be taken at any time either by SIGA, PPD, or the investigator provided there is reasonable cause and sufficient notice is given in advance of the intended termination. Reasons for such action include, but are not limited to: • Study site closure o Inadequate site recruitment/enrollment of subjects o Failure of an investigator to comply with the protocol, PPD SOPs, GCP guidelines, or applicable federal regulations • Termination of enrollment o Enrollment of the required estimated number of subjects for the study • Study termination o Completion of the study o Safety concerns In addition, the ISM and FDA have the prerogative to delay or terminate the study. The end of the study is defined as the date on which the last subject completes the last visit (includes the follow-up visit and the follow-up telephone call). Any additional long-term follow-up that is required for monitoring of the resolution of an AE or finding may be reported through an amendment to the clinical study report.
Study Termination. Although the sponsor has every intention of completing the study, they reserve the right to discontinue it at any time for clinical or administrative reasons.
