Notes

When I review all my visit reports in sponsor-specific systems, I am 100% compliant with all the attributes requested by the sponsor (these attributes are duration, negative dates, first submit, follow up letter sent, finalization and the inititation process ecpecttions as outlined in the sponsor job aid).

I achieve this comliance thanks to my close follow-ups for my cites. I am able to meet the expectations because I have done all my preparations before and after in accordance with the timelines requested by the sponsor. So my expected compliance for my MVRs and FULs for the year to date is 100%.
In addition, I ensure that the compliance of Spectrum data quality and milestone entry per the sponsor navigator tool is 99% and above, by following my sites closely, both individually and with the study team. I also discuss these issues at regular study team meetings and keep them up to date.
I follow routine eTMF site and reconcilation SOP or specific documents before, during and after all my visits. So far, I have completed all of them within the desired time frame. My compliances are also 100% so far. So far, I have not received any warning about this from my CRMs or PLMs.
I have always make a point of the necessary care in action-item both when I took over my study and in the process I am following now. I continue to successfully complete this compliance. So far, I don't have AI that has been open for more than 1 year. I am trying to complete it within the desired and expected timeline.
In my studies that I have taken over, I do not currently have any studies open to patient recruitment.
I fulfill all my responsibilities expected for my studies and requested in the site monitoring plan. In fact, I received special thanks for the support I gave to the study team in the successful completion of the DBL period I carried out in my MK7902-010 study.