Acrp Ccrc Correct Test Paper Answers And Questions Set A.pdf

ACRP CCRC CORRECT TEST PAPER ANSWERS AND
QUESTIONS SET A+
✔✔Global Variables - ✔✔These assess the overall outcomes in objective terms. The PI
may give impressions regarding the study

✔✔Surrogate variable - ✔✔kind of fill in for other variables and are pretty general

✔✔Methods to avoid bias - ✔✔blinding
randomization

✔✔Parallel Trial Design - ✔✔Study Group ----------------> END
Control Group --------------> END

✔✔Crossover Trial Design - ✔✔Study Group ----------> Control Group ------> END
Control Group --------> Study Group ------> END
*main issue is ample wash out time b/w crossovers

✔✔Factorial Design - ✔✔Evaluates two or more treatments simultaneously
*Drug A
*Drug B
*Drug A & B
*Neither Drug A or B

✔✔Blood pressure - ✔✔Systolic/Diastolic

✔✔LFTs - ✔✔Liver Function Tests
Total Protein
Albumin
Bilirubin
ALP (Alk Phos)
AST/ALT

,✔✔Peak - ✔✔Varies, but usually around 30 mins to several hours after dosing,
depends on administration

✔✔Kidney Function - ✔✔BUN (urea nitrogen)
Creatinine

✔✔Nuremburg Code - ✔✔The voluntary consent of the human subject is absolutely
essential

✔✔Date/time on ICF - ✔✔only date is required; time is generally preferred by PIs

✔✔A witness signature is required on ICF when - ✔✔*using a non-English language
short-form ICF
*someone who can comprehend the language, but is unable to read, write, talk or who
is blind
*witness MUST be impartial

✔✔Advocate - ✔✔Is a witness assigned as a monitor to attest to consenting process

✔✔Pre-Clinical Trials - ✔✔Animal/Translational Research - 4.5 years

✔✔Double Dummy - ✔✔both groups of patients in a placebo controlled study take

✔✔Who is ultimately responsible for staff training? - ✔✔PI

✔✔Can PI share study enrollment w/ PCP overseeing care? - ✔✔yes, if subject
agrees/consents

✔✔Who gives IB to investigator? - ✔✔sponsor

✔✔Who gives IB to IRB? - ✔✔investigator

✔✔Does the PI need to notify sponsor of administrative changes to protocol, ICF, etc -
✔✔No

✔✔Who has responsibility for investigational product accountability? - ✔✔PI/Site

✔✔If unblinding occurs who reports & to whom? - ✔✔PI to sponsor only

✔✔LARs may sign for a subject if what conditions exist? - ✔✔-non-therapeutic studies
only
-low risk to subject
- cannot be conducted otherwise
-IRB approves it

, -trial is not illegal by law

✔✔Who reports change of risks to subjects & to whom? - ✔✔PI to sponsor & IRB & site

✔✔Who reports AEs & SAEs / to whom & in what order? - ✔✔PI to 1. sponsor and then
2. IRB

✔✔Premature trial termination should be reported using what schematic? -
✔✔Termination Vortex

✔✔Termination Vortex - ✔✔PI -----> Subjects
Below is a triangle of communication - two way streets with all parties
PI <------> Sponsor
PI <-----> IRB
IRB <------>Sponsor

✔✔Who creates SOPs - ✔✔sponsor

✔✔Who initiates and secures the agreement? - ✔✔sponsor

✔✔A CRO has been enlisted to oversee a study, who is primarily responsible for
integrity of trial data? - ✔✔sponsor

✔✔Expedited reporting of AEs is necessary when what 2 things exist? - ✔✔Serious &
unexpected

✔✔Who appoints a monitor? - ✔✔sponsor

✔✔Who acts as main point of contact b/w the PI & sponsor? - ✔✔monitor

✔✔Monitor should conduct monitoring visits according to what, created by whom? -
✔✔SOPs / monitoring specifics, by the sponsor

✔✔Audits differ from monitoring visits because - ✔✔monitoring visits assess safety of
subjects and day to day data collection & source documents. audits look for compliance
with approved protocols

✔✔Monitors & Auditors differ in what major way? - ✔✔monitors are supplied by sponsor
as part of sponsor team. Auditors are independent.

✔✔An untoward event in a patient or clinical investigational subject administered a
pharmaceutical product which does not necessarily have a causal relationship is what?
- ✔✔Adverse event