Trial Master File

Each document scanned as a separate file and upload in Vault eTMF unless otherwise specified in a SOP

• True

• Flase

Mr. X joined organisation recently as CTA and CDC-PM informed to raise task for on-going completeness checks of STMF on regular basis, however Mr. X is not familiar with frequency of raising tasks. Which of the following document helps Mr. X to understand frequency?

• TMF Masterlist

• ITMF Index and Checklist

• TMF Plan

• TMF Guidance

Mr. X joined organisation recently as CRA and he has few documents, to be filed in respective sections of TMF. However he is not familiar with the level where each document can be filed in the STMF, for example, on trial, country or site level and if in scope for ITMF. Which of the following document helps Mr. X?

• TMF Plan

• TMF Masterlist

• TMF Guidance

• SOP-Filing and Archiving of Documents in the Trial Master File

The following document helps to understand functionality of Vault eTMF

• TMF Guidance

• TMF Plan

Local CTA to ensure trial mailbox or dedicated folder created

• After country allocation

• At time when first country specific documentation in scope for the TMF is ready

• After final

  protocol

• After Country FPFV

EDL finalised timepoint for the milestone IR - First Country Site Initiated

• Trial FSFV + 30 days

• Country LSLV + 30 days

• Country FSFV + 30 days

Monitor performed site close out on 01-Jan-2022 and close out report been approved in IMPACT on 10-Jan-2022. In the current situation, EDL finalised time point for the milestone IR - Site Close

• 01-Jan-2022 + 30 days

• 10-Jan-2022 + 30 days

Monitor performed completeness task for IR - Site initiated and informed CTA to capture “Actual Finish Date” within timeliness. CTA approved all site level documents, checked milestone IR - Site initiated “ and found overall completeness is 95%. What CTA should do?

• Do not mention Actual Finish Date for milestone

• Mention Actual Finish Date for milestone as completeness can be less than 100% for milestone IR-site initiated

When a country or site is closed before LPLV actual has been entered in IMPACT due to no patient recruitment, which of the following is false

• Raise a ticket in ServiceNow to request IR-Country Close Milestone or IR-Site Close Milestone to be created as the Lifecycle state will not be triggered and moved to closing automatically in the eTMF by the IMPACT integration

• No action required as the Lifecycle state will  be triggered and moved to closing automatically in the eTMF by the IMPACT integration

 

Please select which emails can be filed in the STMF

• Audit/inspection related emails

• In/exclusion decisions

• Internal conversation on daily

  logistic and process issues

• The decision-making process around whether or not to include a patient in the study