End of Study Sample Clauses

End of Study. Discontinuation from participation in the study will be documented in the clinical trial database. Reasons for EOS include withdrawal of consent, lost to follow-up, death, or study termination by Sponsor.
Sample 1
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End of Study. Primary completion: This includes time until the last subject is assessed or receives an intervention for the purposes of final collection of data for the primary analysis of the study. The primary completion is expected to occur approximately 6 months after the date the last subject is enrolled to treatment and evaluated for response. End of study: This includes time when the last subject is assessed or receives an intervention for evaluation in the study. The end of study will occur when the last subject discontinues the study treatment and has had the opportunity to complete the safety follow-up visit or the long-term survival follow-up period, whichever is later. The study may end prior to this if 80% of enrolled subjects are deceased prior to the collection of the last survival follow-up.
Sample 1
End of Study. ‌ End of Study will occur when the last patient has completed the 30-day Safety follow up period (after their last dose of study treatment), has withdrawn consent or has died, whichever comes first.
Sample 1
End of Study. EOS will occur 12 months after the primary analysis for XXX. If patients are still receiving clinical benefit from MIRV at EOS, either the study will be amended to allow those patients to continue to receive study treatment with limited data collection (eg SAEs, dosing information) until they are no longer benefiting or patients will be given the option to roll-over to a long-term extension study.
Sample 1
End of Study. Primary Completion: The primary completion of study will occur when target enrollment or randomization is complete and each participant does at least one of the following: End of Trial: The end of trial will occur when target enrollment or randomization is complete and each participant either withdraws from study or completes the week 12 follow up visit or the week 24 long-term follow-up.
Sample 1
End of Study. EOS will occur after the final analysis of OS, which will be conducted when at least 300 deaths have occurred. It is projected that the final analysis for OS will be approximately 1 year after the final analysis of PFS. After the final analysis of OS, the last survival follow-up visit for the last patient will be performed and the study will close. At the time of the final analysis for OS, if patients are still receiving clinical benefit from study treatment at EOS, either the study will be amended to allow those patients to continue to receive treatment with limited data collection (eg SAEs, dosing information) until they are no longer benefiting or patients will be given the option to roll-over to a long-term extension study.
Sample 1
End of Study. Visit (7 ± 2 days after last study visit or decision to terminate) 54
Sample 1
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End of Study. Visit (7 ± 2 days after last study visit or decision to terminate) • Collect and review completed diary. • Perform physical examination (see Section 9.10). • Measure height and weight. • Calculate BMI and BSA (see Appendix 14.5). • Measure xxxxx xxxxx (blood pressure, heart rate, respiratory rate, and oral body temperature, see Section 9.11). • Obtain clinical laboratory tests (serum chemistry, hematology, and urinalysis, see Section 9.7). • Obtain a 12-lead ECG (see Section 9.9). • • Administer the VAS measurement of swallowing difficulty (see Section 9.13). • Record concomitant medications. • Monitor AEs. • A meal or snack will be ingested between 30 and 60 minutes after RP103 dosing. • Administer Q12H RP103 dose with an acceptable food or liquid as described in Appendix 14.9. • Collect a cysteamine PK sample 0.5 hour (30 minutes) post RP103 dose administration. Actual collection time will be recorded. • Collect a WBC cystine PD sample 0.5 hour (30 minutes) post RP103 dose administration. Actual collection time will be recorded. For patients that terminated from the Study and transitioned onto Cystagon® treatment: • Collect a cysteamine PK sample immediately prior to their next Cystagon® dose administration. Actual collection time will be recorded. • Collect a WBC cystine PD sample immediately prior to their next Cystagon® dose administration. Actual collection time will be recorded. If a subject has any clinically significant, Study drug-related abnormalities at the conclusion of the study termination, the Investigator will determine if the subject has to be followed further. If the Investigator determines that a subject has abnormalities that require additional monitoring, the subject may be asked to return to the clinic until the abnormalities resolve or will be allowed to return home and will be followed up by telephone until resolution. If the subject is to be followed up, the Medical Monitor (or designated representative) should be notified. Every effort should be made to arrange follow-up evaluations at appropriate intervals to document the course of the abnormalities.
Sample 1

Related to End of Study

  • Feasibility Study A feasibility study will identify the potential costs, service quality and other benefits which would result from contracting out the work in question. The cost analysis for the feasibility study shall not include the Employer’s indirect overhead costs for existing salaries or wages and benefits for administrative staff or for rent, equipment, utilities, and materials, except to the extent that such costs are attributable solely to performing the services to be contracted out. Upon completion of the feasibility study, the Employer agrees to furnish the Union with a copy if the feasibility study, the bid from the Apparent Successful Bidder and all pertinent information upon which the Employer based its decision to contract out the work including, but not limited to, the total cost savings the Employer anticipates. The Employer shall not go forward with contracting out the work in question if more than sixty percent (60%) of any projected savings resulting from the contracting out are attributable to lower employee wage and benefit costs.

  • Study An application for leave of absence for professional study must be supported by a written statement indicating what study or research is to be undertaken, or, if applicable, what subjects are to be studied and at what institutions.

  • Evaluation of Students Acknowledging the District’s adopted grading system, the teacher shall maintain the right and responsibility to determine grades and other evaluation of a student. No grade or evaluation shall be changed except by the teacher with the approval of the building administrator.

  • Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

  • Clinical Studies The animal and other preclinical studies and clinical trials conducted by the Company or on behalf of the Company were, and, if still pending are, to the Company’s knowledge, being conducted in all material respects in compliance with all Applicable Laws and in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical study and clinical trials of new drugs and biologics as applied to comparable products to those being developed by the Company; the descriptions of the results of such preclinical studies and clinical trials contained in the Registration Statement and the Prospectus are accurate and complete in all material respects, and, except as set forth in the Registration Statement and the Prospectus, the Company has no knowledge of any other clinical trials or preclinical studies, the results of which reasonably call into question the clinical trial or preclinical study results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described; and the Company has not received any written notices or correspondence from the FDA, the EMA, or any other domestic or foreign governmental agency requiring the termination, suspension or modification of any preclinical studies or clinical trials conducted by or on behalf of the Company that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus.

  • DEVELOPMENT OR ASSISTANCE IN DEVELOPMENT OF SPECIFICATIONS REQUIREMENTS/ STATEMENTS OF WORK

  • Multiple Measures of Student Learning Measures must include a combination of classroom, school and district assessments, student growth percentiles on state assessments, if state assessments are available, and student MEPA gain scores. This definition may be revised as required by regulations or agreement of the parties upon issuance of ESE guidance expected by July 2012.

  • The Study 1The parties must comply with, and conduct the Study in accordance with, the Protocol and any conditions of the Reviewing HREC. In addition the parties must comply with the following, as applicable:

  • RE-WEIGHING PRODUCT Deliveries are subject to re- weighing at the point of destination by the Authorized User. If shrinkage occurs which exceeds that normally allowable in the trade, the Authorized User shall have the option to require delivery of the difference in quantity or to reduce the payment accordingly. Such option shall be exercised in writing by the Authorized User.

  • Development Phase contractual phase initiated with the approval of ANP for the Development Plan and which is extended during the Production Phase while investments in xxxxx, equipment, and facilities for the Production of Oil and Gas according to the Best Practices of the Oil Industry are required.

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