End of Study Clause Samples

The "End of Study" clause defines the point at which a clinical trial or research study is considered officially concluded. It typically specifies the criteria or events that mark the study's completion, such as the last participant's final visit, database lock, or submission of the final report. This clause ensures all parties are clear on when study-related obligations end, facilitating proper closure of activities, regulatory reporting, and resource allocation.
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.
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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 ▇▇▇▇▇ ▇▇▇▇▇ (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.
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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.
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End of Study. Visit (7 ± 2 days after last study visit or decision to terminate) 54
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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.
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End of Study. EOS will occur 12 months after the primary analysis for ▇▇▇. 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.
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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.
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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.
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Related to End of Study

  • Feasibility Study Buyer is granted the right to conduct engineering and/or market and economic feasibility studies of the Property and a physical inspection of the Property, including studies or inspections to determine the existence of any environmental hazards or conditions (collectively, the “Feasibility Study”) during the period (the “Feasibility Period”) commencing on the Effective Date and ending at 5:00 p.m., Central Time, on the June 3, 2010. With Seller’s permission, after Seller has received advance notice sufficient to permit it to schedule in an orderly manner Buyer’s examination of the Property and to provide at least 24-hours’ advance written notice to any affected tenants, Buyer or its designated agents may enter upon the Property during normal business hours for purposes of analysis or other tests and inspections which may be deemed necessary by Buyer for the Feasibility Study. Buyer or its designated representative must be accompanied by a designated representative of Seller or have received Seller’s written permission prior to entering upon the Property in connection with Buyer’s Feasibility Study; provided, however, Buyer may not enter into any space leased by any tenant without being accompanied by a designated representative of Seller. Seller agrees to make its representative reasonably available during normal business hours. Buyer will not alter the physical condition of the Property or conduct invasive testing without notifying Seller of its requested tests, and obtaining the written consent of Seller to any physical alteration of the Property or invasive testing. Buyer will utilize commercially reasonable diligence to conduct or cause to be conducted all inspections and tests in a manner and at times which will not unreasonably interfere with any tenant’s use and occupancy of the Property. If Buyer determines, in its sole judgment, that the Property is not suitable for any reason for Buyer’s intended use or purpose, or is not in satisfactory condition, then Buyer may terminate this Contract by written notice to Seller prior to expiration of the Feasibility Period, in which case the ▇▇▇▇▇▇▇ Money (other than the Option Money) will be returned to Buyer, and neither party shall have any further right or obligation hereunder other than as set forth herein with respect to rights or obligations which survive termination. If this Contract is not terminated pursuant to this Section 5(a), then after expiration of the Feasibility Period, after Seller has received advance notice sufficient to permit it to schedule in an orderly manner Buyer’s examination of the Property and to provide at least 24-hours’ advance written notice to any affected tenants, Buyer or its designated agents may enter upon the Property during normal business hours. Buyer or its designated representative must be accompanied by a designated representative of Seller or have received Seller’s written permission prior to entering upon the Property; provided, however, Buyer may not enter into any space leased by any tenant without being accompanied by a designated representative of Seller. If this Contract is not timely terminated pursuant to this Section 5(a), Buyer’s right to terminate this Contract pursuant to this Section 5(a) and any and all objections with respect to the Feasibility Study will be deemed to have been waived by Buyer for all purposes.

  • 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 A teacher shall maintain the right and responsibility to determine grades and other evaluation of students within the grading policies of the District based upon professional judgment of available criteria pertinent to any given subject area or activity for which the teacher is responsible. No grade or evaluation shall be changed without consultation with the teacher.

  • 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 or the Prospectus, or the results of which are referred to in the Registration Statement 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 EMA, Health Canada and other comparable regulatory agencies outside of the U.S. to which they are subject, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, 312, and 812; the descriptions of the results of such studies, tests and trials contained in the Registration Statement 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 Registration Statement or 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 or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMA, 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 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.