Common use of Study Duration Clause in Contracts

Study Duration. For subjects, the study will consist of a Screening period of up to 30 days (can be extended in certain circumstances see Section 5.2.1), with randomisation at the Treatment Visit (Day 1) up to 14 days later (can be extended if UTI prevents IMP administration - see Section 5.2.3). Follow-up for each subject is planned to be 24 months (104 weeks) after the first IMP administration. However, as retreatments can occur up to Week 104, and 12 weeks of follow- up will occur following each study retreatment, the maximum planned subject participation following randomisation is 116 weeks. Each subject's participatiou iu the study will be considered to have ended at the time of their last study visit, including follow-up for AEs after the last IMP administration: • CCI The study will be considered to have started when the first subject has provided signed informed consent and to have ended after the last subject has completed their last study visit.

Appears in 1 contract

Sources: Investigator Agreement

Study Duration. For subjects, the study will consist of a Screening period of for up to 30 days (but can be extended in certain circumstances circumstances, see Section 5.2.1), with randomisation at the Treatment Visit (Day 1) up to 14 days later (can be extended if UTI prevents IMP administration - see Section 5.2.3). Follow-up for each subject is planned to be 24 months (104 weeks) after the first IMP administration. However, as retreatments can occur up to Week 104, and 12 weeks of follow- up will occur following each study retreatment, the maximum planned subject participation following randomisation is 116 weeks. Each subject's participatiou iu ’s participation in the study will be considered to have ended at the time of their last study visit, including follow-up for AEs after the last IMP administration: • CCI . The study will be considered to have started when the first subject has provided signed informed consent and to have ended after the last subject has completed their last study visit.

Appears in 1 contract

Sources: Investigator Agreement