What situations below should be reported to GDQ?
Malfunctioning Defective
change in physical appearance
Expired thermometers or no temperature data
Locally sourced products
Who should complete the final packaging and sealing of clinical supplies?
How long does CRA/CRM submit essentials to CTA? (For In-house Trials)
Within 10 calendar days after TMF reconciliation is performed.
No late than EDA form signed after is received or generated.
Within 15 calendar days after TMF reconciliation is performed.
Within 30 calendar days after TMF reconciliation is performed.
For initial Site level Main Informed development process, which are correct?
If no change compared with country ICF, doesn’t need any approvals
If changes are required need follow HQ and Country Informed Consent Author and Negotiation Guidelines to negotiate and obtain appropriate approvals
After obtaining relevant Substantive change approvals, CRA sends site level ICF to CRM for final approval
After obtaining relevant Substantive change approvals, CRA sends site level ICF to CRD for final approval.
6. Clinical Supplies can be shipped before the Essential Document Approval (EDA) form is completed.
All clinical supply complaints /GCP inquires need to be reported of the first aware of the issue.
within 1 calendar day
within I business day
Who will assess domestic SAE is SUSAR or not?
please choose the correct description of ALCOA
Attributable, Legible, Consistent, Original, Accurate
Available, Legible, Consistent, Oriented, Accurate
Available, Legible, Contemporaneous, Original, Accurate
Attributable, Legible, Contemporaneous, Original, Accurate
What is the timeline for compliant /GCP inquires report?
