ACRP CCRA/CCRC Certification Exam prep

ACRP CCRA/CCRC Certification Exam
prep 2025\2026

Adverse h,Event h,(AE)/Adverse h,Experience h,- h,answerAny h,untoward h,medical h,occurrence h,in h,a h,patient
h,or h,clinical h,investigation h,subject h,administered h,a h,pharmaceutical h,product h,and h,which h,does h,not


h,necessarily h,have h,to h,have h,a h,causal h,relationship h,with h,this h,treatment.




Adverse h,Drug h,Reaction h,(ADR) h,- h,answerAll h,noxious h,and h,unintended h,response h,to h,a h,medicinal
h,product h,related h,to h,any h,dose.




Unexpected h,Adverse h,Drug h,Reaction h,- h,answerAn h,adverse h,reaction, h,the h,nature h,or h,severity h,of h,which h,is
h,not h,consistent h,with h,the h,applicable h,product h,information h,(e.g., h,Investigator's h,Brochure h,for h,an


h,unapproved h,investigational h,medicinal h,product). h,(See h,Section h,III.c)




Serious h,Adverse h,Event h,(Experience) h,or h,Reaction h,- h,answerIs h,any h,untoward h,medical h,occurrence h,that
h,at h,any h,dose:




Results h,in h,death,



Is h,life-threatening



"life-threatening" h,in h,the h,definition h,of h,"serious" h,- h,answerIn h,the h,definition h,of h,"serious" h,refers h,to h,an
h,event h,in h,which h,the h,patient h,was h,at h,risk h,of h,death h,at h,the h,time h,of h,the h,event; h,it h,does h,not h,refer h,to h,an


h,event h,which h,hypothetically h,might h,have h,caused h,death h,if h,it h,were h,more h,severe.




Requires h,inpatient h,hospitalization h,or h,prolongation h,of h,existing h,hospitalization,

,Results h,in h,persistent h,or h,significant h,disability/incapacity,



or



Is h,a h,congenital h,anomaly/birth h,defect.



Marketed h,Medicinal h,Products h,- h,answerA h,response h,to h,a h,drug h,which h,is h,noxious h,and h,unintended
h,and h,which h,occurs h,at h,doses h,normally h,used h,in h,man h,for h,prophylaxis, h,diagnosis, h,or h,therapy h,of


h,disease h,or h,for h,modification h,of h,physiological h,function.




"Unexpected" h,Adverse h,Event/Reaction h,- h,answerThe h,nature h,or h,severity h,of h,which h,is h,not h,consistent
h,with h,information h,in h,the h,relevant h,source h,document(s). h,Until h,source h,documents h,are h,amended,


h,expedited h,reporting h,is h,required h,for h,additional h,occurrences h,of h,the h,reaction.




"Expected" h,Adverse h,Event/Reaction h,- h,answerFor h,a h,medicinal h,product h,not h,yet h,approved h,for
h,marketing h,in h,a h,country, h,a h,company's h,Investigator's h,Brochure h,will h,serve h,as h,the h,source h,document


h,in h,that h,country.




Reports h,which h,add h,significant h,information h,on h,specificity h,or h,severity h,of h,a h,known, h,already
h,documented h,serious h,ADR h,constitute h,unexpected h,events.




Applicable h,Regulatory h,Requirements h,- h,answerAny h,laws h,and h,regulations h,addressing h,the h,conduct h,of
h,clinical h,trials h,of h,investigational h,products. h,(ICH h,GCP h,E6 h,1.4)




"Approval" h,(in h,relation h,to h,Institutional h,Review h,Boards) h,- h,answerThe h,affirmative h,decision h,of h,the h,IRB
h,that h,the h, clinical h,trial h,has h,been h,reviewed h,and h,may h,be h,conducted h,at h,the h,institution h,site h,within


h,the h,constraints h,set h,forth h,by h,the h,IRB, h,the h,institution, h,Good h,Clinical h,Practice h,(GCP), h,and h,the


h,applicable h,regulatory h,requirements.

,Audit h,- h,answerA h,systematic h,and h,independent h,examination h,of h,trial h,related h,activities h,and
h,documents h,to h,determine h,whether h,the h,evaluated h,trial h,related h,activities h,were h,conducted, h,and h,the


h,data h,were h,recorded, h,analyzed h,and h,accurately h,reported h,according h,to h,the h,protocol, h,sponsor's


h,standard h,operating h,procedures, h,(SOPs), h,Good h,Clinical h,Practice h,(GCP), h,and h,the h,applicable


h,regulatory h,requirement(s).




Audit h,Certificate h,- h,answerA h,declaration h,of h,confirmation h,by h,the h,auditor h,that h,an h,organization h,audit
h,has h,taken h,place.




Audit h,Trail h,- h,answerDocumentation h,that h,allows h,reconstruction h,of h,the h,course h,of h,events.



Blinding/Masking h,- h,answerA h,procedure h,in h,which h,one h,or h,more h,parties h,to h,the h,trial h,are h,kept
h,unaware h,of h,the h,treatment h,assignment. h,Single-blinding h,usually h,refers h,to h,the h,subject(s) h,being


h,unaware, h,and h,double- h,blinding h,usually h,refers h,to h,the h,subject(s), h,investigator(s), h,monitor, h,and, h,in


h,some h,cases, h,data h,analyst(s) h,being h,unaware h,of h,the h,treatment h,assignment(s). h,(ICH h,GCP h,E6 h,1.10)




Case h,Report h,Form h,(CRF) h,- h,answerA h,printed, h,optical, h,or h,electronic h,document h,designed h,to h,record h,all
h,of h,the h,protocol h,required h,information h,to h,be h,reported h,to h,the h,sponsor h,on h,each h,trial h,subject.




Clinical h,Trial/Study h,- h,answerAny h,investigation h,in h,human h,subjects h,intended h,to h,discover h,or h,verify h,the
h,clinical, h,pharmacological



and/or h,other h,PD h,effects h,of h,an h,IP(s), h,and/or h,to h,identify h,any h,AEs h,to h,an h,IP(s), h,and/or h,to h,study
h,absorption, h,distribution, h,metabolism, h,and h,excretion h,of h,an h,IP(s) h,with h,the h,object h,of h,ascertaining


h,its h,safety h,and/or h,efficacy.




Clinical h,Trial/ h,Study h,Report h,- h,answerA h,written h,description h,of h,a h,trial/study h,of h,any h,therapeutic,
h,prophylactic, h,or h,diagnostic h,agent h,conducted h,in h,human h,subjects, h,in h,which h,the h,clinical h,and


h,statistical h,description, h,presentations, h,and h,analyses h,are h,fully h,integrated h,into h,a h,single h,report.




Comparator h,(Product) h,- h,answerAn h,investigational h,or h,marketed h,product h,(i.e., h,active h,control), h,or
h,placebo, h,used h,as h,a h,reference h,in h,a h,clinical h,trial.

, Compliance h,(in h,relation h,to h,trials) h,- h,answerAdherence h,to h,all h,trial-related h,requirements, h,GCP
h,requirement h,and h,the h,applicable h,regulatory h,requirements.




Confidentiality h,- h,answerPrevention h,of h,disclosure, h,to h,other h,than h,authorized h,individuals, h,of h,a h,sponsor's
h,proprietary h,information h,or h,of h,a h,subject's h,identity.




Contract h,- h,answerA h,written, h,date, h,and h,signed h,agreement h,between h,two h,or h,more h,involved h,parties
h,that h,sets h,out h,any h,arrangements h,on h,delegation h,and h,distribution h,of h,task h,and h,obligations h,and, h,if


h,appropriate, h,on h,financial h,matters. h,protocol h,may h,serve h,as h,the h,basis h,of h,a h,contract.




Coordinating h,Committee h,- h,answerA h,committee h,that h,a h,sponsor h,may h,organize h,to h,coordinate h,the
h,conduct h,of h,a h,multicenter h,trial.




Coordinating h,Investigator h,- h,answerAn h,investigator h,assigned h,the h,responsibility h,for h,the h,coordination h,of
h,investigators h,at h,different h,centers h,participating h,in h,a h,multicenter h,trial.




Contract h,Research h,Organization h,(CRO) h,- h,answerA h,person h,or h,an h,organization h,contracted h,by h,the h,sponsor
h,to h,perform h,one h,or h,more h,of h,a h,sponsor's h,trial-related h,duties h,and h,functions.




Conducts h,Trials.



Direct h,Access h,- h,answerPermission h,to h,examine, h,analyze, h,verify, h,and h,reproduce h,any h,records h,and
h,reports h,that h,are h,important h,to h,evaluation h,of h,a h,clinical h,trial.




Documentation h,- h,answerAll h,records, h,in h,any h,form h,(including, h,but h,not h,limited h,to, h,written,
h,electronic, h,magnetic, h,and h,optical h,records, h,and h,scans, h,x-rays, h,and h,electrocardiograms) h,that


h,describe h,or h,record h,the h,methods, h,conduct, h,and/or h,results h,of h,a h,trial, h,the h,factors h,affecting h,a h,trial,


h,and h,the h,actions h,taken.




Essential h,Documents h,- h,answerDocuments h,which h,individually h,and h,collectively h,permit h,evaluation h,of
h,the h,conduct h,of h,a h,study h,and h,the h,quality h,of h,the h,data h,produced.