Microglia May24

The RPA creates Unblinded for Veeva PPD TMF

• True

• False

Answer explanation

1Unblinded FROs will also be created by the RPA if there is an Unblinded Siebel CTMS. These will have the same frequency and schedule as the Blinded FROs. Ensure that the site statuses in Blinded and Unblinded CTMS match because the RPA will use the Unblinded CTMS as a source for creation of Unblinded FROs.

Which type of document does NOT file the RPA for MVR filing?

• PSV Report

• Confirmation Letter

• MVR Report

• SIV Report

Answer explanation

This automation does not file Pre-study visit and Pre-study/Site Initiation visit reports for qualified and disqualified sites since often a site has not been created yet in PPD's eTMF at this timepoint. The automation will not file confirmation or follow-up letters. These visit related letters need to be filed manually according to the current process.

If my study use TMF of Sponsor, should I complete an Internal FR in Veeva PPD TMF?

• Yes

• No

Answer explanation

Yes, completing an Internal FR in Veeva PPD TMF is necessary when using the TMF of the Sponsor in your study.

Living documents should be collected on each MVR.

• True

• False

Answer explanation

Final version of the documents will be collected during the COV. No need to delete partial versions.

Momento de descanso mental. ¿Cuanto es 1+1?

• Esta no

• Esta tampoco

• 2

• Has avanzado demasiado, vuelve a la c.