Online Class Notes (Ally)

practice how to describe problem

Vocabulary

whole number: 整数的

My boss admit that I can work from home.

It was very good

how to answer them quickly and properly

I’m less pressured

Hi, thank you very much for yesterday’s meeting. I have seen that you have take very quick actions of the protocol amendment, just say thank you. Because it is an opportunity for the protocol amendment, so we think whether the question of the d can be listed in the protocol amendment. In our protocol, it is required that d should be administered before the usage of the drug. It is 4 mg. maybe in US and Europe a common tablet size, however in CHina, one tablet D is 0.75 mg. It is not a whole tablet so it is not very convenient for us to use this kind of usage for this D. Since we have already consulted David for suggestions. He suggested that it is reasonable to administer 5 tablets, because this is within 10% protocol mandated value. However, this situation may be flagged as protocol deviation. That means every Chinese patient would be listed as a protocol deviation. So it is necessary for us to change the protocol. If there are lots of deviations, that means the quality of the study is not very good. Since there’s a systemic reason, and there’s no real deviation such as…. you missed some tests. If we make changes in the protocol, there would not be so many deviations.

Hi, thank you very much for yesterday’s meeting. I have seen that you have taken very quick actions for the protocol amendment we discussed yesterday, so I just wanted to say thank you so much for that. Since we are already making a change, we also wanted to bring forward two protocol deviation related issues. The first one is whether the question of the d can be listed in the protocol amendment as well. In our protocol, it is required that 4 mg of d should be administered before the usage of the drug. Maybe in the US and Europe, it is the common tablet size, however in CHina, the standard size of one tablet of D is 0.75 mg. It is not a whole number so it is not very convenient for us to use this kind of usage for D. We have already consulted David for suggestions and he suggested that it is reasonable to administer 5 tablets, because this is within 10% protocol mandated value. However, this situation would be flagged as protocol deviation, which means that actually, every Chinese patient would be listed as a protocol deviation. So we want to suggest making a change in the protocol. As you know, if there are lots of deviations, it would influence the quality and the credibility of the study. Since there’s a systemic reason, and there’s no real deviation such as administering a drug too late or missing a test, it would be a shame to influence the study. If we make changes in the protocol, we can avoid these deviations.

Also, I’m sorry to bring up another issue. According to our current protocol, R and other drugs should be administered in one day. As you know, it takes a lot of time to prepare the drugs, so the earliest possible time we can administer the drug is at noon. Combined with the slow infusion rate of R, it will take at least 3 hours to complete the usage of R alone. The investigators consider the risk of the infusion and they cannot administer other drugs in one day because it is too late. Usually, other drugs will be administered at night because we have already spent at least 3 hours to use R. The investigators think it’s not very safe to do that.

Thank you so much for listening to all of our requests. Please tell us what you think and if it is possible to make these revisions.

When the patients can use the drug, it would be at noon.
The earliest time they can use the drug is at noon.

Pronunciation

deviation