ACRP CCRC LATEST 2026 PAPER QUESTIONS AND
ANSWERS GRADED A+
✔✔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
✔✔an adverse drug reaction requires what level of causality? - ✔✔reasonable
possibility
✔✔ADRs should be expeditiously reported when what two factors are present? -
✔✔serious/unexpected
✔✔fatal / life threatening ADRs should be submitted in what time frame? - ✔✔no later
than 7 days, but ASAP
✔✔Other serious, but non-fatal / life-threatening ADRs should be reported in what time
frame? - ✔✔ASAP, no more than 15 days
ANSWERS GRADED A+
✔✔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
✔✔an adverse drug reaction requires what level of causality? - ✔✔reasonable
possibility
✔✔ADRs should be expeditiously reported when what two factors are present? -
✔✔serious/unexpected
✔✔fatal / life threatening ADRs should be submitted in what time frame? - ✔✔no later
than 7 days, but ASAP
✔✔Other serious, but non-fatal / life-threatening ADRs should be reported in what time
frame? - ✔✔ASAP, no more than 15 days
