General

Start up Topics

1) SPONSOR applications
a) Are there more applications to be used in the studies?
b) What information is stored in each one?
c) Who is in charge of updating anduploading information to those applications?
d) Who is in charge of grant access for the application?
e) Is it planned that all DM's have access to all the applications (even external users)?2) Timelines (all the timelines for the study not just data management)
a) Where are stored?
b) Is there a report to get the information about timelines?
c) Who is in charge ofdefining timelines?
d) How timelines are defined?

3) PCDM's data management experience.
Share real cases or how did the resolve some issues.

4) SPONSOR DM's
a) Could it be possibleto have more communication with them?
b) Is it possible to be included in the DM's meeting they all have (SPONSOR and DM's together)?

5) Processes
Clear definition of roles andresponsabilities of Programming, DE and Data management

6) Training on:
a) SAS datasets review (to DMs and programmers)
b) Loaded data: how this DCIs are tested by the programmer, how those look like
c)Electronic data transfers


7) Holidays and Vacations
We propose to create a standard format to record study team holidays and vacations in order to have the activities well organized andplanned

8) Contact list information
a) Who is reponsible for collect this?
b) Is this stored somewhere?
c) Is there a standard format? Some of us received the file in excel, other in word andsome others in pdf
d) Who is responsible to have updated the file? We have contact information not to date or incomplete


9) Shipment
Who is in charge of payment negotiation?
Some of uswere requested to provide information about who will pay the shipment or for a FEDEX account.

10) Other items
Questions and Answers's open session

Conduct Topics

a) SAE reconciliation...