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.
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.
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.
End of Study. Visit (7 ± 2 days after last study visit or decision to terminate) 54
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.
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.
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.
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.