Study Oversight

During the start-up phase, the CTM and /or designated VM confirm if the vendor accepts the procedure for __/__ described in G-WI-014

• Database lock

• Sfety reporting

• TMF

• Unblinding

• Risk based monitoring

CMC Development (KKC)/Clinical Supplies (KKNA) prepares and updates QTA at study start, review QTA on an ongoing basis

• True

• False

The kick-off meeting is necessary even if the same vendor from a previous phase study is being used for the next phase study and utilize the same methods

• True

• False

CRO/vendor meetings provide a forum for ongoing communications regarding study status, risk issue identification, management, deliverables, timeline, (a)   , and early resolution to any outstanding issues.

All documentations from the CRO/vendor meetings are stored in the Project-specified TMF

• True

• False

Investigator GCP training should include

• SAE reporting

• Management of Urgent Safety Measures

• Confirmation of eligibility/enrollment and discontinuation

• Escalation and management of Serious Breaches of GCP