make formal: PI is managing all aspects of the protocol process with SubI Hale Gokcan. At the previous MV (on 20 May 2024), due to an internet connection problem, the CRA was unable to connect to the CDMS. This slowed down the CRA's work, and not all SDVs could be completed. Therefore, with approval from LDL, this additional visit was arranged with SubI.
Generally, SubI Hale Gokcan is conducting patient follow-ups in consultation with the PI. After site activation, 5 screening visits (3 screen failures, 2 randomized) were performed. The informed consent process was carried out according to ICH-GCP guidelines and documented.
The Principal Investigator (PI) is overseeing all aspects of the protocol process in collaboration with Sub-Investigator (SubI) Hale Gokcan. During the previous monitoring visit (MV) on May 20, 2024, the Clinical Research Associate (CRA) encountered an internet connectivity issue, which impeded access to the Clinical Data Management System (CDMS). Consequently, this disruption delayed the CRA's work, preventing the completion of all Source Data Verifications (SDVs). With the approval of LDL, an additional visit was subsequently scheduled with SubI Hale Gokcan to address these outstanding tasks.
In general, SubI Hale Gokcan is responsible for conducting patient follow-ups in consultation with the PI. Following site activation, five screening visits were conducted, resulting in three screen failures and two randomizations. The informed consent process was executed in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP) guidelines and was duly documented.