make formal: PI is managing all aspects of the protocol process with SubI Hale Gokcan. Due to the PDs and issues at this site, CRA had received approval from LDL to perform MV once every 4-5 weeks. Generally, SubI Hale Gokcan is conducting patient follow-ups in consultation with the PI. SubI monitors all evaluations and lab results of all study patients. AE questioning was conducted during patient visits in accordance with the protocol. There are no safety issues for this site. SubI stated that he did not have any questions about the protocol.
CRA Sevgi Yilmaz informed CRA Sevgi Yilmaz informed the site that she is transferring monitoring responsibilities to CRA Merve Kazoglu since 02 Jul 2024. Onsite-handover was performed and CRA Merve Kazoglu introduced herself. CRA Sevgi Yilmaz salso sent to the site an email and LDL about it. LDL will inform the global study team about CRA change.
The Principal Investigator (PI) is overseeing all aspects of the protocol process in collaboration with Sub-Investigator (SubI) Hale Gokcan. Due to the protocol deviations and issues at this site, the Clinical Research Associate (CRA) has received approval from the Lead Development Liaison (LDL) to conduct monitoring visits (MV) once every 4-5 weeks.
SubI Hale Gokcan is generally responsible for conducting patient follow-ups in consultation with the PI. SubI Gokcan monitors all evaluations and laboratory results of study patients. Adverse Event (AE) questioning is conducted during patient visits in accordance with the protocol. There are no safety issues reported at this site. SubI Gokcan has confirmed that he does not have any questions regarding the protocol.
CRA Sevgi Yilmaz has informed the site that she is transferring monitoring responsibilities to CRA Merve Kazoglu effective from July 2, 2024. An onsite handover was performed, during which CRA Merve Kazoglu introduced herself. Additionally, CRA Sevgi Yilmaz sent an email to the site and LDL regarding the change. The LDL will inform the global study team about the CRA transition.