Online Class Notes (Ally)

Vocabulary

get-to-know-you meeting: 新见面会

run-down: 扼要报告 meeting 事项 in order 依照顺序的

I didn’t have a close communication with them.

the persons all changed

I don’t know what they will perform in the study

– five global colleagues from clinical sci depts
– my line manager and I

– introduction

– ask about others role in the study

– introduce some specific topics: review process of patient eligibility worksheet, medical monitor (how to issue queries from our side), risk I’ve learned from the judgment of relapse of disease from PI.

– other info? anything to share?

Meeting:

Good morning everybody. This is the first meeting we restart the screening process. Since we have not known each other, I will briefly introduce myself.

Good morning everybody. This is our first meeting since we restarted the screening process. As many of us are not very familiar with each other yet, I will briefly introduce myself and maybe afterwards, we can go around, and everyone could share their role in the study too.

My name is rainbow, clinical physician from company A, and I have been working on this study for about a year, and I’m responsible for the close-monitoring plan. Most of you are probably familiar with this plan, so you will know what my work is about. Could you please briefly introduce your role or your responsibilities in the study?

As we’re based in China, we’re better informed about the situation here in China, but of course, you know more about the global picture of this study, so in this meeting, maybe we can share these information with each other and facilitate the progress of this study. This is the main purpose of this meeting.

Firstly, I want to discuss the following 3 topics: the first one is regarding the patient eligibility worksheet review. The Eng version of the worksheet has just recently been created for your convenience. This version will only be for the global medicals’ information, just for your reference, and not for official usage and no PI signature will be provided in this English version.

The second topic is about the real-time medical detail monitoring. We want to discuss how to send query to the sites. Usually it is an efficient way to send queries directly in the EDC system, but we are not allowed to do so in this study. We have to send our queries to global medicals, and wait for them to post the queries through a tracker, which is quite inconvenient. We have already been informed that China-specific inquiries are not appropriate for the global study, but I want to argue that what I do according to the close monitoring plan is not contrary to the global medical monitoring. They are compatible with each other. The China-specific plan and global plan are not in contradiction with each other. So if you agree, I want to send queries directly in the EDC system, and if you’re willing to send me the global detailed review plan, I can check the detailed query points to make sure they’re appropriate before sending them in the system.

The third topic of today is on the judgment of the PI’s consideration of relapse or refractory disease. After the subject signs the ICF, it is the PI’s call to judge whether the patient is relapse or refractory and enter this information into the system. However, if they’re wrong, we cannot change this information in the system. So, to avoid any mistakes, we want to send the PI a newsletter to notify them of the specific definition of relapse and refractory disease. 

Before the restarting of the screening, all of the worksheets are in Chinese, because the prior global physician also know Chinese. But now, the global medicals don’t know the Chinese, so we created English version of the eligibility worksheet. This has already been created.