Email Service Notes (Jesse)

Your Original Email

Last week, we held the SIV (site initiate visit) meeting. We received the investigator’s feedback. What they are most concerned is the efficiency of the response to the questions from the site. They care more about the turn-over time from the question received to the response given. I have collected the information about that and categorized them into three aspects.
1. Firstly, the investigators need timely support to answer the protocol related questions. This is also done by the competitor companies in China. (so should company A address the questions related to that? )
2. Secondly, although the protocol has a clear statement of the inclusion/ exclusion criterion. Everyone has a different understanding of these criterion. The Chinese investigators expect to discuss with the medical monitor case by case. Usually, the subjects are hospitalized, so they cannot wait for a day. They need answers for a few hours rather than one day. (How can company A support this kind of questions?)
3. Thirdly, the investigators are not so experienced about the management of the agent. They will have more questions about these during the study conduct. (How can company A support this kind of questions?) We Chinese medical monitor may just know the drug safety based on the Chinese different sites. These may cause some inconsistent explanations about the management.

Based on what we observed in the SIV, we conclude the following risks
Firstly, if we delay answering the questions from the investigators, it will cause a negative impact on the passion and even the enrollment of the study.
Secondly, if the response about the AE management is delayed, it will have a negative impact on the safety of the subjects.

Your Edited Email

Last week, we held the SIV (site initiate visit) meeting and we received the investigator’s feedback. What they are most concerned about is the efficiency of the response to the questions from the site. They care more about the turn-over time from the question received to the response given. I have collected the information about it and categorized it into three aspects.
1. Firstly, the investigators need timely support to answer the protocol related questions. This is also done by the competitor companies in China. (so should company A address the questions related to this? )
2. Secondly, although the protocol has a clear statement of the inclusion/ exclusion criterion. Everyone has a different understanding of these criterion. The Chinese investigators expect to discuss with the medical monitor case by case. Usually, the subjects are hospitalized, so they cannot wait for a day. They need answers in a few hours rather than one day. (How can company A support this kind of question?)
3. Thirdly, the investigators are not so experienced with the management of the agent. They will have more questions about this during the conducting of the study. (How can company A support this kind of question?) As a Chinese medical monitor, we may just know the drug safety based on the Chinese different sites. These may cause some inconsistent explanations of the management.

Based on what we observed in the SIV, we concluded the following risks:
Firstly, if we delay answering the questions from the investigators, it will cause a negative impact on the passion and even the enrollment of the study.
Secondly, if the response about the AE management is delayed, it will have a negative impact on the safety of the subjects.