F2F Class Notes 24th March (Raph)[W]

Vocabulary

Proactive (adj): 1- taking action by causing change and not only reacting to change when it happens:
E.g.: Companies are going to have to be more proactive about environmental management.

Environment (n): 1- the air, water, and land in or on which people, animals, and plants live. 2- the conditions that you live or work in and the way that they influence how you feel or how effectively you can work.
E.g.: We’re not doing enough to protect the environment from pollution.
E.g.: The office is quite bright and airy – it’s a pleasant working environment.

Decision

Original: 

as you know ,there are 2 sites of this project: for the Beijing Cancer Hospital, the EC meeting will be held on the early of next month, and CRA need keep close contact with SUB-I and GCP office and EC staff avoid to there are some addition requirement and some changes;
for the Cancer Hospital of Chinese Academy of Medical Sciences ,it is on the set up and EC submission period , Due to this site GCP and EC staff on the handover period and the process is not very clear, so we need CRA do the PSSV and also keep close contact with the site GCP officer and EC and Sub-I in Beijing.

By the way, the sponsor also is very aggressive, they stare at us of all the actions with sites.

So it would be appreciated if you could find a CRA to take over Yuting’s work for these 2 site by next Monday?

Edited:

As you know, there are 2 project sites: for the Beijing Cancer Hospital, the EC meeting will be held early next month/will be held at the beginning of next month, and CRA needs to keep close contact with SUB-I, GCP office, and EC staff to avoid additional requirements and changes.
For the Cancer Hospital of Chinese Academy of Medical Sciences, it is on the initial and EC submission period. Due to this site, GCP and EC staff are in the handover period and the process is not very clear, so we need CRA to do the PSSV and also keep close contact with them.

• Thanks for your supporting for the Yuheng PD-1 Project and Cstone PD-L1 project , recently the 4 projects are all initiated, I draft a resource form assignment according to the communication with all of you. Could you please review it and feel free to let me know if any error or question?

• these venders have been signed the CDA with CDS ,and they will keep confidential , once you selecte them for translation ,they could signed a CDA with CSTONE.

• Could you please provide a training for the protocol of PD-1 Project of Sun Yat-sen University Cancer Center to our operation team asap ?