This deliverable reports on the recruitment situation of the 29-month IDEA-FAST Clinical Observational Study (COS, initially called Clinical Validation Study) after the first 6 months. Up to the date of submission, 265 participants have been recruited, which is encouraging given that circumstances such as different regulations and requirements of local ethics committees (concerning ethics applications) and legal departments (concerning site agreements) led to a delayed start of the COS. In addition, recruitment was markedly hampered by the Corona pandemic. Those teams that were able to recruit report feasible assessment across the visits. Participants are reporting back that the study is meaningful and future-oriented in their view. As far as can be judged with the current data and our own experience as sponsor / cohort leads, the compliance of the participants is excellent and there is a very good retention rate. Nevertheless, the current recruitment rate is still below our target recruitment rate. This is partly because it took considerably longer to implement the required site agreement at some of the recruiting sites due to slow responses from their legal teams. Until this agreement was in place, recruitment could not start at these sites. In order to overcome this slow start, the following adaptations to the initial COS strategy have been initiated: (i) facilitating recruitment of participants at the individual sites, (ii) adding more institutions to the recruiting centres, i.e. departments that are located at already recruiting sites, and (iii) supporting teams from local study sites and inform them as well as possible. With these adaptations, we are optimistic that we will still reach our final target of N=2000 in January 2025. This is supported by the enormous commitment of all people involved, including patients.
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