To save time, would it be possible to use the format of the Chinese report from the start of the process?
It is not easy for us to modify our procedure for a single country. We need standardization to ensure quality.
This project is considered a priority by our top management. If it is not possible to adapt our process, can we consider
the option of subcontracting the report to external parties in China?
It was decided to keep the data management internally to ensure good control of the whole process. I will check what we can
do and come back to you.
"The leader focuses on timelines," said Norma Lynn Fox, senior director of clinical research at Human Genome Sciences in Rockville,
Maryland. Fox was one of three class participants who tackled the case study. "But the data manager wants to follow the process
exactly." Instead of explaining her issues or asking about the data manager's concerns, the leader just keeps pushing the
point about timelines, Fox's group showed. In the end, the regulatory affairs manager bunkers down in his silo, while the
data manager essentially argues that the leader fails to see what is required for a quality report.
Fox and two colleagues, Eric Bouilloux, global project leader at Ipsen in Slough, UK, and Linda Wolf, leader of emerging markets
and services for BBK Healthcare in Newton, Massachusetts, came up with a new version. Here, the leader reframes the goal
from shortening a timeline (a result) to soliciting ideas (expanding group knowledge).
Thanks for agreeing to meet. This project has high priority, plus speed is important. We need to generate some options to
speed up. Maybe we could take some time to look at the 12 months of time it takes to produce case reports.
It takes six months for us.
Leader: (To RA) What do you do?
The Chinese coordinator has to take data management's standard report, translate it into Chinese, and re-format it. Then,
it's translated back into English and validated by us. Could we reformat the reports at the start?
We need six months to get the reports done on our end.
I'm hearing that you, data manager, need six months and then you, regulatory affairs manager, need an additional six months.
I think we should use the Chinese format from the start.
No, I think we should...
RA: (Interrupts) If we started with the Chinese format, we could save a lot of time.
DM, I'm hearing you have another solution.
We could provide a format to the regulatory affairs manager that would work for both the Chinese coordinator and for our
Good. We found one place to save time. It's still a 12-month process. Are there other options? Other people who can help?
Give me two weeks and I will get back to you with additional ideas.