Study Management Overview MinJi Son Clinical Trials Management Associate, Clinical Operations Gilead Sciences

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[Audio] I'm MinJi Son Clinical Trials Management Associate within Clinical Operations at Gilead Sciences. I will be sharing an overview of study management which includes Meeting Agendas Communication Pathways Study Management Study timelines/milestones and Safety Overviews such as S-A-E and pregnancy..

[Audio] "Communication Pathway" plays an essential role in Clinical Operations Study Management. This responsibility involves working with the individual study participants to determine the appropriate communication path for the study ensuring effective delivery and communication as well as maintaining a secure state that allows for important members of Clinical Operations to share the correct information..

[Audio] PPD CRA 선생님들은 교수님들의 주요 연락 담당자입니다. ISF 바인더에 있는 Study Contact List를 확인하면 해당 연락 담당자들의 정보를 알 수 있습니다. 모든 문제에 대해 스터디 관련하여 PPD CRA 선생님들에게 즉시 연락을 취하시기 바랍니다..

[Audio] We are discussing study management focusing on the timeline and milestones associated with the study. Utilizing a timeline and milestones to keep track of progress will help keep the study on the right track and guarantee its completion on schedule..

[Audio] 우리는 핵심 마일스톤과 타임라인을 테이블로 보여드리겠습니다. 2023년 11월6일 캐나다 토론토에서 기본 작업이 시작되었고 2023년 12월5일에는 첫번째 환자가 스크리닝 된 것으로 보입니다. 처음 등록된 환자는 2023년 3월15일로 나온 것입니다. 마지막 환자는 2025년 7월 3일로 예상되고 마지막 방문은 2027년 5월 13일로 예상하고 있습니다..

[Audio] I will provide insight on our Study Management approach covering contracted vendors monitoring activities visit schedule I-M-P dosing instructions and any reminders you may require..

[Audio] Our C-R-O partner is P-P-D providing project management site monitoring and regulatory and medical expertise. Signant Health is being used for eCOA and IRT. Its services include subject questionnaires and clinical reported outcomes IP management and dispensation and sites activation/deactivation and enrolment/randomization. This slide is regarding the vendors used for the palekona study..

[Audio] I'm MinJi Son from Gilead Sciences Clinical Operations and in this session I will be presenting insight on overall study management. This includes a discussion about the vendors we use for Electronic Data Capture endoscopy central reader central laboratory and travel/expense reimbursement. Specifically we use Medidata Rave for EDC Alimentiv for endoscopy central reader and Labcorp for blood urine and stool analyses. Lastly travel and expense reimbursement is taken care of by Scout Clinical..

[Audio] All required materials must be obtained before activating the site in order to ensure successful trial execution. This includes completing essential documents receiving study supplies from Signant Health LabCorp and Alimentiv and if needed any extra equipment. Plus access to all related study systems must be accessible to the site before activation..

[Audio] We currently use 100% Source Data Verification or S-D-V but we will be transitioning to a more risk-based approach in 2024. This approach includes onsite monitoring site health assessment and centralized monitoring. Remote S-D-V is only permitted as a mitigation during pandemic or other official travel restrictions and Gilead must provide approval before any remote S-D-V is implemented at a site. All strategies should be aligned with local regulations..

[Audio] Clinical Operations at Gilead Sciences is dedicated to providing comprehensive study management. To ensure adherence to a rigorous timeline for monitoring visits the first monitoring visit should take place within two weeks plus / one week of the first subject randomized. After this subsequent monitoring visits should be conducted approximately every six weeks plus / one week. For sites that are not enrolling subjects the first monitoring visit should take place within 90 days of site activation..

[Audio] The Clinical Trial visit schedule starts off with screening followed by randomization on Day 1. During the Study scheduled visits occur at Weeks 2 4 8 12 16 20 24 28 32 36 40 44 48 and 52 with a window of ±3 days excluding Weeks 32 and 36 which have a window of ±5 days and Weeks 40 44 48 and 52 which have a window of ±7 days. Additionally the Early Termination visit and the Post Treatment visit take place within 30 days after the end of the Treatment..

[Audio] For this slide I would like to provide an overview of the IMP Dispensing and Administration Instructions for this trial. During the blinded treatment phase from Day 1 to Week 12 participants will receive two bottles of the GS-5290 300 milligrams or placebo and one bottle of the GS-5290 150 milligrams or placebo for a total of three bottles. They will be told to take one tablet from each bottle orally per day. For the Week 12 to Week 52 phase participants will receive one bottle of the GS-5290 300 milligrams or placebo and one bottle of the GS-5290 150 milligrams or placebo for a total of two bottles. Again they will be instructed to take one tablet from each bottle orally per day. Dispensing will be done on specific weeks throughout the trial..

[Audio] For the non-responder treatment phase of GS-5290 participants will receive two bottles of 300 milligrams tablets and take one tablet from each bottle per day for a total of two tablets. At week 12 participants will transition to taking one tablet of 300 milligrams for weeks 12 16 20 24 28 32 36 40 44 and 48..

[Audio] It is important for Clinical Operations associates to remember to not use local laboratory test results as part of the study assessment. Where feasible it is best to stick to the predetermined protocol and procedures for the study instead of using local testing..

Thank you!.