eTMF

Question 1

3 stages of TMF maintenance

Answer 1

set-up, manage, closeout

Question 2

TMF operational agreement

Answer 2

for Service Provide Rep and study leader to document 1. service provider TMF responsibilities and sponsor responsibilities.. 2. Defines sponsor expectations. 2. clarifies ownership of task/activities/info asked during inspections

Question 3

purpose of generic study TMF workbook

Answer 3

est & agree on document-level responsibilities with service provider. Based on DIA model. Generic TMF workbook is basis for RRM on which eTMF structure is based.

Question 4

important activities for end of TMF set up:

Answer 4

establish the TMF quality plan (process for review and oversight of TMF).
2. finalize the Study TMF Workbook: specifies document responsibilities within internal functions

Question 5

what document is also in place for outsourced studies

Answer 5

a signed TMF operational agreement which identifies Sponsor & Service Provide TMF responsibilities.

Question 6

what is required to begin study close-out process

Answer 6

1. final review of TMF performed according to TMF Quality Plan to ensure TMF sections contain complete/accurate dox.
2. if working with service provider, ensure they are complying with contractual obligations.
3. TMF documentation completeness check.
4. After Study Database Lock

Question 7

Additional activities required during life of TMF

Answer 7

1. TMF Quality Review Oversight
2. Archive the TMF
3. Retrieval, Return & Destruction

Question 8

purpose of TMF

Answer 8

how Roche tells HA the story behind the research & clinical trials to demonstrate drug’s efficacy, safety and use.

Question 9

CSFM

Answer 9

process to document when TMF not filed appropriately.