Per the Protocol
ECG
RealTime
LSC
EDC
Research 101
100
The trial in which every screening subject must have Fibroscan completed during screening visit (historical scan not accepted).
What is the Boehringer Ingelheim (BI) trial?
100
Three common issues with ECG placement
What are:
1. Electrodes placed on woman's breast tissue
2. Wires crossed
3. Electrodes and leads not lying flat on body
Note: Electrode for lead V4 should be placed underneath the breast tissue in women. If necessary, the electrode for lead V5 should also be placed underneath breast tissue.
100
The RealTime equivalent to CC's "Conditions"
What is Medical History section
100
NASH is the acronym for...
What is Non Alcoholic Steato Hepatitis?
100
The only active FTM trial to use a system other than Medidata for EDC.
What is Northsea (NST)?
100
Definition of protocol deviation
What is when, without significant consequences, the activities on a study diverge from the Institutional Review Board-approved protocol
200
The kPa and CAP score minimum requirements for Madrigal trials.
What is 8.5 and 280
200
ECG results the CRC/ Sub I should immediately be notified of (1 example).
Current possible Myocardial Infarction
200
2 ways to link medications and medical history/conditions in RT
1. In "Medical History" section, use "Add TMT"
2. In "Meds and Treatments" section, use "Add Cond"
200
The difference between NAFL and NASH.
What is:
NAFL= CAP/Fat >248, kPa/Stiffness <7
NASH= CAP/Fat >248, kPa/Stiffness >7 OR Fat with Inflammation
200
Identify the meaning of this symbol in Medidata
What is a change has been made to this field
200
True/False: Informed Consent refers to just the process associated with signing enrollment papers before starting a trial.
What is false.
Informed consent is an ongoing process.
300
This vital sign is not collected in the Northsea screening visit.
Respiratory Rate
(Side note: This also doesn't need to be collected in Poxel screen visits either!)
300
Another ECG and vital sign finding to notify CRC/Sub I of immediately.
BPM/HR less than 60 or more than 100.
300
The information entered into RT CTMS for a new referral prior to LSC visit.
All demographic, contact info, medical history, medications, and lab results available in medical record provided in referral.
300
The length of time a patient is asked to fast before a Fibroscan.
What is 3 hours
300
For Akero 0102:
Selection entered in Medidata for Fibroscan results without a Valid Measurements count on the report?
What is Number of Valid Measurements not available
Note: FS software in FTM office currently does not show valid measurement count.
300
The language of consent form used with patient relies on this.
What is the language the patient speaks and speaks fluently (without concerns of loss in translation).
400
A screening patient, before being seen by the CRC, asks to use the restroom. The patient explains that she/he has to pee and asks whether urine for lab work should be collected at this time.
What should be explained to this patient?
What is no study procedures can be completed before signing the Informed Consent Form (ICF).
Because the urine collection time would be before the time the signature was collected on the ICF, the urine can't be used for the lab work.
400
The BI QTCf cut off for screening patients
What is QTCf >450.
400
A reason a RT user may not be able to enter information into a RT source form during a subject visit.
What is another user is logged in and has entered the same page.
Note: There is a time lag even after a user has exited the page and logged off before the page will be unlocked for other users.
400
Important reminder associated with packing up the Velacur.
What is turn off the machine completely before disconnecting the probe.
400
Daily Double!
Three ways queries can be generated in EDC systems.
1. Automated system
2. Data manager looking at data remotely
3. Study monitor/CRA during monitoring visits.
400
True or False: Compensation for participation in a trial is considered a potential benefit of enrollment.
What is false.
Compensation presented as a benefit for participation in research is considered coercive. Compensation is allowed, but not to be presented as a benefit.
500
Study/Studies that have possible prescreen visits written into the protocol, different from Covenant LSC visits.
What are Madrigal 11 and Madrigal 14
500
Describe/draw ideal electrode placement positions.
500
RT organizes patients according to this in the system.
What is study
500
IQR threshold for scan to be considered reliable
20% (Covenant) and 22% (trials)
500
Medical history terminology listed in EDC should match the written information in source to this extent.
What is exactly/identically.
500
Areas of source RA team members can complete and sign to endorse completion.
What is tasks delegated to him/her in the delegation log.