TMF Plan
COSL, TMF Ops, CRO Project Lead
Who approves and signs the TMF Plan?
Blueprint TMF standards that we expect our CRO partners to follow.
What is the CRO playbook?
Record Owner
Which function is accountable for filing the record in the TMF?
If it isn't __________, it did not happen!!
Documented
ELNOMEIST
Milestone
Completeness Questions and Milestones
What is one of the first tasks a COSL or Designee is expected to perform at study set-up in PhlexTMF?
Library of TMF resources and trainings available to the CRO partners
What is the CRO training curriculum?
Zone 6
What zone are ISO records filed in the TMF?
Quarterly......ish!
What is the frequency of our TMF spotlight?
ISGEDENE
DESIGNEE
No later than 60 days post original protocol finalization
When should the study specific TMF Plan and Index be finalized?
The term used for TMF Records that are created and updated throughout the life cycle of the study
What are living documents?
Veeva RIM
What is the official repository for regulatory TMF records?
Leigh Carter
Who is our PhlexTMF Customer Success Manager (CSM)?
SAMTSGNENSI
ASSIGNMENTS
FRM-00207, PhlexTMF Quality Review Request Form
What needs to be completed to enable TMF Ops to create QR packages
BPMC TMF Set Up Checklist – All TMF Scenarios
What checklist is presented during a new study TMF KOM?
Budgets and Financial Agreements
Which TMF records are not filed in PhlexTMF, as per the TMF Index?
March 2022
When was the TMF Ops department initiated at Blueprint?
RNTSALIANTOS
TRANSLATIONS
3 months post first site activation
When is the first QR initiated for a study in start up?
English translation > Parent document untranslated > Certificate of translation > Optional – back translations and certificates (if applicable)
When filing a parent document with a translation as a package, what is the acceptable order to be filed?
Version 3.1
What version of the TMF reference model structure was adapted for the TMF Index tool?
45 Sidney Street, 5th Floor
Where is the DCR room located?
ETSEILSMIN