BODPOD
A participant in our study is from African descent. Which ethnicity should be chosen when conducting the BODPOD?
Other
According to the SOP for TANITA, which of the following maintenance should be inspected at least weekly? (Answer may be more than one option)
A) Date and time settings
B) All cables, cords, and connecter ends for damage/ contamination
C) Mounting screws on stand
D) Display for any damage or contamination
B and D
TRUE OR FALSE?
If an AE is serious, the investigator will report it to the regulatory bodies within 7 days of being aware of the incident.
FALSE. Within 24 hours.
Do we report the SP’s EQ-5D-5L score to the PI?
NO
How should blood samples be stored?
Immediately on ice
Mention at least 2 points the CRA must inform the Study Participant to do prior to the BODPOD measurement
1. Remove shoes and excess clothing
2. Remove any jewelry
3. Put on a swim cap
4. Put on a swimsuit
How often should the BODPOD be DEEPLY cleaned?
On a weekly basis
Which of the following statements is FALSE in regards to the process of reporting AE?
a) AEs will be collected from the electronic medical records and research visits
b) At each study visit, the SP will be asked about any experiences by asking “Since your last visit, have you experienced any problems?”
c) If the SP reports an AE, the CRA completes an AE form and evaluates the seriousness of the event without reporting to the PI
d) If no AEs were reported by the SP, the CRA should still check the electronic medical records for AEs, complete an adverse event form if AEs were found, and report the event to the PI
C. If the Study Participant reports an AE, the CRA completes an AE form and reports the event to the PI, who then evaluates the seriousness of the event
The EQ-5D-5L primarily measures which of the following?
A) Pain severity and its impact on physical function only.
B) Mental well-being through a single dimension focused on depression.
C) Health-related quality of life across physical and mental dimensions, with five levels of severity.
D) The effectiveness of medical treatments based on symptom improvement
C
A sample was rejected due to contamination. According to the SOP, what should be done?
For any reason if samples are rejected, CRAs must immediately inform the PI to determine the appropriate solution
How often does calibration of BODPOD by pressing the Quality Control button have to occur?
One time daily before Study Participants are scheduled to arrive
Which equipment assess plethysmography?
BODPOD
Which of the following reasons for admission to a hospital is considered an adverse event?
a) Miscarriage
b) Preterm labor
c) Delivery
d) Congenital anomaly/ birth defect
D
Who can complete the EQ-5D-5L questionnaire?
Both the CRA and SP
Yousra is 15 weeks pregnant and is a part of this study. A blood sample is requested from her. Her HC number is HC02386579. Her QID number is 29484000785. Her PLESTID is PLEST0001. What information would be included in the specimen labelling?
PLEST ID only
In the case of a power failure, how many minutes does the BODPOD’s battery have before it shuts off?
45 minutes
A SP comes in and Enas will start with checking her BP. Which statement in relation to cleaning the machine is INCORRECT?
a) To clean the monitor, dampen a soft cloth with little soap and water, wring, and gently clean the monitor
b) To disinfect the monitor, dampen a soft cloth with isopropyl alcohol (70% solution in water), wring, and thoroughly wipe the monitor
c) To clean the cables and external power supply, dampen a soft cloth with alcohol-free hand soap, wring, and gently clean. Then clean again with water
d) To disinfect the cables and exteral power supply, dampen a soft cloth with isopropyl alcohol (70% solution in water), wring, and gently clean. Clean again with a soft cloth dampened in water only
D*
*3% solution of sodium hypochlorite
Christina has 3 adverse event forms. Where should she file them?
1. Original goes to regulatory binder
2. Copy goes to adverse event file
3. Copy goes to subject file
TRUE/ FALSE: The EQ-5D-5L questionnaire should be given by the CRAs to the Study Participants, without a need of informing them of the purpose. They should ask the Study Participants if they have any questions. Before proceeding, and ensure they fully understand how to complete the questionnaire and understand the terminology
Answer: FALSE. Walk through with the participant. Need to inform them of the purpose.
How can a CRA confirm the SP’s ID when doing blood sampling?
Confirm the SP’s ID, consent form, and blood collection tube label match using PLEST ID and confirm the SP’s identity by QID
List 3 out of 5 of the exclusion criteria for BODPOD listed in the SOP
Study Participants with claustrophobia
Study Participants who cannot stand up and sit still, for example with increased urinary urgency or tremors.
Study Participants who have been strenuously physically active up to 2 hours before the measurement
If a Study Participant has eaten or drunk up to 2 hours before the measurement. Taking medication with water allowed, if necessary
If the SP is sick (any upper respiratory tract infection)
Sort the steps for cleaning the Fibroscan probe.
A SP comes in for a follow up visit. Hawra asks her if she experienced any problems since her last visit, and she said no. After she left, Hawra checked her electronic medical and found she was admitted to the hospital for pregnancy-induced hypertension. According to the SOP, what should she do?
The AE is not serious. The CRA should record it in the SP’s CRF and AE log, allow it to be managed medically as appropriate, and follow until resolution
List 4 out of 5 domains found in EQ-5D-5L
Match the cap color to the collection tube name/ specification
Purple- EDTA
Green- Heparin
Yellow- Serum separator gel tubes
Red/grey- Serum separator gel tubes- alternative
Red- Serum tubes- another alternative
Clear- PAXGene tube