Adjudication
The system sites use to share redacted source documents with DCRI
What is Duke Box
What are the exact dates for the Event Sweep?
What is June 11th –July 8th
GDMT is a key datapoint for the trial. Total daily dose, Dose Unites and Start/End Dates need to be reported accurately (TRUE/FALSE)
What is TRUE
Subject who discontinues study medication early, need to Initiate FINAL visit as well as complete DS01, DOLC (TRUE/FALSE)
What is FALSE?
Biggest country in Asia
What is China
Sites should only respond to CEC queries requesting source documents once they have uploaded the source. (TRUE/FALSE)
What is TRUE
The “VICTOR Safety and Efficacy Event Sweep Site Aid, Section IV: Guide for conducting event sweep phone contacts” can be used during the phone discussions with participants and filed as source document in the participant’s binder. (TRUE/FALSE)
What is false?
Per protocol, SM restart or up titration should NOT occur if the mean SBP< 100 mmHg (TRUE/FALSE)
What is TRUE?
Need to initiate a new visit (DOV) in InForm for an AD-HOC sweep call to enter PEID or event eCRFs (TRUE/FALSE)
What is FALSE?
All data from the sweep contact should be entered in the previous visit by adding additional entries
City (or country) hosts Summer Olympics 2024
What is Paris (France)
If a site has requested a source document but is not including it within the current source package submission, which option should be checked on the coversheet?
What is Not Available
If the participant is contacted during the Event Sweep and does not have any recent event to report in this contact, the site will still need to complete this eCRF
What is Potential Endpoint Identification (PEID)?
Name one country in EMEA that had queries <= 5 days in average as of Apr 2024
What is Greece,Turkiye, Denmark, Austria, Spain, Ukraine, Sweden
Minimum eCRF to be entered for the Event Sweep:
- Subject Disposition (DS01) or Date of Last Contact (DOLC)
- Potential Endpoint Identification (PEID) or Vital Status (VST)
- Vital Signs (VS02) or Protocol Milestone Status (PMS1)
Potential Endpoint Identification (PEID) or Vital Status (VST)
Nick name of Bangkok (The Big Apple, The Land of Smiles, The Big Mango)
What is The Big Mango
What is the best tool to utilize for redaction of patient identifiers?
What is Electronic/PDF Redaction Tool
For the Event Sweep (11Jun-08Jul), the data collected during phone contacts or participants’ site visits, needs to be entered in InForm as soon as possible, during the Event Sweep, no later than this date
What is 09Jul
It’s strongly recommended that data is entered in InForm as soon as it is collected and no later than July 9th
The 2 actions that sites need to perform during the accelerated 1-1-1 cycle time
- 1 day to perform data entry after visit completion
- 1 day to answer queries
Which eCRFs need to have consistent data with Dose Modification Assessment (DMA) eCRFs?
DOLC, VS02, SM, PROC
What is VS02 and SM?
The only Southeast Asian country that was never colonized by a European country
- Vietnam
- Philippines
- Thailand
What is Thailand
If a site receives new information about an event already sent for adjudication, what are the 2 steps that need to be taken?
What is
1. Update event narrative in EDC
2. Duke Box Submission
If a participant’s visit is scheduled right before the Event Sweep or after the Event Sweep, what does site staff need to do?
What is:
1) rescheduling the participant’s visit within the visit intervals
or
2) keep the scheduled visit and schedule an ad-hoc phone contact during the Event Sweep time frame
VICTOR has Selective Event Reporting. Selected NSAEs are nonserious AEs that meet which criteria per Protocol section 8.4?
• AE that leads to study intervention dose modification or discontinuation
• AE that leads to withdrawal from the study
• COVID-19 disease-related AE
Correct way of recording study medication:
A. Occasional gaps and overlaps are ok
B. Enter study medication taken up to the last visit date
C. It’s acceptable to skip recording a few missed doses, if not remembered by subject
B. Enter study medication taken up to the last visit date
If you visit one new beach in Australia every day, it would take over this many years to see them all:
- 1 year
- 17 years
- 27 years
What is 27 years