Online Class Notes (Tibo)

Now I am still adjusting to the new environment.
It is a bit similar to the previous job, but I don’t know if it is the honeymoon period

I have a presentation tomorrow. this is my first time to have a presentation and this meeting will involve my boss and other colleagues / this is the first time I will present to my boss and other colleagues

This trial is in the starting up phase so we need to discuss some issues.

It is like tumor in your bone marrow

patients may have the risk of thrombosis -> patients may be at risk of suffering from a thrombosis

we faces issues in China -> we face issues in China

There are 24 sites and not all of them can do the testing on site. / some of them are unable to do the tests
So we may face the issue of an audit or inspection.    / we face a regulatory risk in case of inspection
The labs do not have certificate.
They need to prove they have the ability to do this task.

For the sites who cannot do it, they will send the sample to a third party, but if this third party involve in clinical trial it will cause difficulties. -> if the third party is involved in the clinical trial it will add more operational difficulties.

In their thoughts -> from their perspective

They think investigators in China can confirm each diagnosis because it should be their responsibility.

The study requires the patient to do additional tests to confirm the diagnosis.

only the patients who are diagnosed with this disease can be involved in the study.

-> at the start of the study we need to ensure that only patients diagnosed with the disease are enrolled and that means we need to confirm the diagnosis before starting the trial.

If the global colleagues agree to set up special labs there are also risks…

The global team has identified labs to support this.

The lab is the only qualified la in global but it is not for bone marrow testing in China -> That lab is qualified in other countries but it is not currently qualified in China.

The lab is not present in China yet and it needs validation, it needs to be qualified.

We got the info the lab will be ready in China in Q2 or Q3.
We need more info and the  exact / specific time line for the lab set up.
What is the back up plan if the lab set up is delayed.

the global colleagues have given some comments.

Pronunciation

present

diagnose

diagnosis

manual

Vocabulary

jargon (n) specific vocabulary in an industry
Normal people do not understand the medical jargon