SOA
When are PK draws done during study visits?
Predose (except for D1)
How do you correct an error on a log/source documents?
Always use a single line through the incorrect entry, write correct information above and initial and date
What temperature IP is stored at?
Room temperature
What is the conditional TCD velocity range?
170-199cm/s
Where you answer TCD queries?
Bioclinica portal
Does every subject have to complete the Post dose Taste and Palatability Questionnaire?
No - only subjects ≥ 5 years who are taking PfOS
What do you do to empty spaces on a log?
Cross out empty spaces, initial and date
What is the maximum amount of time prepared PfOS can sit before administration?
10 minutes
What is the accepted range for Hgb for inclusion in the study?
≥ 5.5 - ≤ 10.5
How many TCDs are to be performed at applicable study visits?
2 TCD assessments are required within 30 minutes
Should Malaria, HIV Serology and Hepatitis assessments be completed at Screening?
No - only if clinically indicated
Is using whiteout acceptable?
Using whiteout or blinding an error is not an acceptable form of correction and should be avoided to maintain transparency
True or False: Returned study drug can be re-dispensed?
False
How many VOCs in the past 12 months would exclude a subject from participating in the study?
More than 10 VOCs that require hospitalization, ER visit or clinic visit
What arteries are insonated during TCD assessments?
MCA and dICA
Do you measure the head circumference of all subjects?
No - only subjects aged 2 - <4 years
Should you dispose of a sticky note used to record vitals?
No - Every originally captured piece of data must be retained, rather than replaced or deleted.
If PfOS is not available, dispersible tablets can be used? True or False
True - 100mg and 300mg dispersible tablets are now available
If a child's weight increases, is the site allowed to increase the HU dosage?
Yes - it is a weight-based dose
Are lab assessments required if the TCD value is not conditional at screening?
No - if the TCD is not conditional (unless it is a re-scan), labs should not be drawn
Does Day 1 require a TCD assessment?
No - PA3 no longer requires a TCD to be done on Day 1
What are the new letters in ALCOA
ALCOACCEA
If a participant takes more than the protocol-defined dose and does not experience any AEs. Is this considered an overdose?
No - but it has to be reported as a PD
Is malaria testing required for all participants?
No - only required if clinically indicated in malaria-prevalent regions
At study visits, when should be the TCD assessments be performed?
First