PPS Team Meeting 09 March 2021 Vilnius

COL task transfer to PS. Which tasks may be transfer to PS?

• Introduction letter

• Safety report

• Contribution to collection of CSR appendices

• All mentioned above

Vendors need to file PI documents in TMF. What actions vendor should take?

• Send the documents he wants to file to PS

• Send documents to TMF mailbox

• Send documents to RMA

• Send documents to study specific outlook mailbox

How often team list must be filed in TMF?

• On a monthly basis

• After each update done on team list

• On a quarterly basis

• Before each MPOR meeting

New checklist is available for?

• 1-1 meetings

• Project team member handovers

• Study Maintenance

• Project team member birthdays tracking

Which system is used now to create site personnel and site centers in IH?

• SIS

• SIMS

• SAS

• SIMPSON

New sites creation and data integration

• Data flows from Vault to IH

• Data flows from IH to Vault

Removal of secondary RMA technical Quality Check (QC) of documents (PMED & Vault, studies in sponsor systems)

• Document Owners are responsible for the First Time Quality (FTQ) of their documents

• Document Owners review at least 95% of all document types and finalize in the TMF

• RMAs are responsible for the First Time Quality (FTQ) of team documents

My Systems Access Tool implementation will enable us to move to a more robust process of how we manage our accesses to all systems and to simplifications for our team as well as all stakeholders. Who will lead pilot activities for PPS:

• Birgit Garmer

• Agne Kriauciuniene

• Regina Vaitkeviciene

• Oprah Winfrey