Study Termination. Failure In biochemical activity is defined when the measured value at a certain time point deviates in the mean [*****]% from the original value measured at time (t=O). Failure of [*****]% of the kits with respect to the testing criteria, 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. 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. Patients who either complete the Study or terminate the Study early will have an End of Study (EOS) visit within 7 days (± 2 days) of their last completed study visit. examination, xxxxx xxxxx, Clinical laboratory assessments, ECG, physical will be performed according to the Schedule of Events. Blood samples for PK (cysteamine) and PD (WBC cystine) will be collected 0.5 hour post RP103 dose administered at the clinic. For patients who have transitioned back to Cystagon®, PK and PD samples will be collected immediately prior to their next Cystagon® dose. Adverse events and concomitant medications will be collected. Other Study Procedures: Females of child-bearing potential will provide a menstrual cycle history and be administered a serum pregnancy test at Screening (new patients only), and at each scheduled study visit. Height, weight, BMI and BSA determination will be performed at each visit according to the Schedule of Events.
Study Termination. Occurrence of two deaths suggesting a reasonably possible relationship with continuous exposure to NI- 0501 and occurring in similar conditions will trigger the decision to terminate the study. This process will involve both the DMC and the Investigators. The management of patients already enrolled in the study will also be part of the DMC recommendations.
Study Termination. The sponsor reserves the right to close the investigational site or terminate the study at any time. Investigational sites will be closed upon study completion. An investigational site is considered closed when all required documents and study supplies have been collected and a site closure visit has been performed. The investigator may initiate site closure at any time, provided there is reasonable cause and sufficient notice is given in advance of the intended termination. Reasons for the early closure of an investigational site by the sponsor or investigator, or termination of a study by the sponsor, may include but are not limited to: ● Failure of the investigator to comply with the protocol, the sponsor’s procedures, or GCP guidelines ● Safety concerns ● Sufficient data suggesting lack of efficacy ● Inadequate recruitment of subjects by the investigator ● Significant delays in submitting data or inability to follow subjects
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) 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 up to the effective date of termination and any reasonable non- cancelable costs which were incurred by 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, Institution shall promptly return the excess balance to CRO. (c) Neither CRO nor Sponsor shall be responsible to the Institution for any lost profits, lost opportunities, or other consequential damages. Institution shall not be responsible to neither to CRO nor Sponsor for any lost profits, lost opportunities or other consequential damages. 16.
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.
