ACRP CCRC Exam Questions With Correct Answers

ACRP CCRC Exam Questions With Correct
Answers


ADR ///- ///verified ///answer(s)-✔✔Adverse ///Drug ///Reaction



Audit ///- ///verified ///answer(s)-✔✔Reviews ///how ///the ///research ///was ///conducted; ///takes ///into
///account ///SOPs, ///IRB ///requirements ///& ///GCP ///(ensures ///compliance)




Audit ///Certificate ///- ///verified ///answer(s)-✔✔Confirmation ///audit ///took ///place



Audit ///Report ///- ///verified ///answer(s)-✔✔Written ///Evaluation ///- ///not ///regularly ///made
///available ///to ///regulatory ///body; ///only ///when ///serious ///evidence ///exists ///concerning ///non-


compliance



Audit ///Trail ///- ///verified ///answer(s)-✔✔Documentation ///of ///audit ///events



Single ///Blind ///Study ///- ///verified ///answer(s)-✔✔Subjects ///Unaware



Double ///Blind ///Study ///- ///verified ///answer(s)-✔✔Subjects ///& ///Researchers ///are ///unaware



Comparator ///- ///verified ///answer(s)-✔✔Item ///used ///as ///an ///active ///control ///references ///in ///a
///clinical ///trail




Coordinating ///Committee ///- ///verified ///answer(s)-✔✔Group ///a ///sponsor ///comprises ///to
///coordinate ///multi-center ///trials

,Coordinating ///Investigator ///- ///verified ///answer(s)-✔✔An ///investigator ///who ///oversees
///multiple ///sites ///of ///a ///clinical ///trial ///(multicenter)




IDMC ///- ///verified ///answer(s)-✔✔Independent ///Data ///Monitoring ///Committee, ///Data ///&
///Safety ///Monitoring ///Board ///(DSMB), ///Data ///Monitoring ///Committee: ///Oversee ///safety ///&


///progress; ///make ///recommendations ///to ///continue, ///modify ///or ///stop




IEC ///- ///verified ///answer(s)-✔✔Independent ///Ethics ///Committee; ///group ///who ///oversees
///protection, ///rights, ///safety ///& ///well-being ///of ///human ///subjects




Investigator's ///Brochure ///- ///verified ///answer(s)-✔✔Compilation ///of ///data ///on ///an
///investigational ///product ///used ///in ///human ///subjects




Legally ///acceptable ///representative ///- ///verified ///answer(s)-✔✔person ///whom ///is ///lawfully
///able ///to ///consent ///on ///behalf ///of ///another




SAE ///- ///verified ///answer(s)-✔✔Serious ///Adverse ///Event ///- ///Results ///in ///death, ///is ///life-
threatening, ///requires ///long-term ///hospitalization, ///results ///in ///long ///term
///disability/hospitalization ///incapacitation ///or ///is ///a ///congenital ///birth ///defect




Source ///data ///- ///verified ///answer(s)-✔✔original ///clinical ///information ///from ///source
///documents ///(medical ///record ///information)




Vulnerable ///subjects ///- ///verified ///answer(s)-✔✔*Hierarchical ///structure ///employees

*armed ///forces

*detainees

*incurable ///disease ///pts

,*homeless

*poor

*those ///in ///nursing ///home

*minors

*those ///unable ///to ///give ///consent



ICH ///- ///verified ///answer(s)-✔✔International ///Conference ///on ///Harmonization



Principles ///of ///ICH ///& ///GCP ///- ///verified ///answer(s)-✔✔*Protect ///research ///subjects

*conduct ///research ///as ///it ///has ///been ///approved

*research ///should ///be ///clear, ///organized ///& ///approved ///by ///an ///IRB/IEC



IRB //// ///IEC ///Responsibilities ///- ///verified ///answer(s)-✔✔*Oversee ///principles ///of ///ICH/GCP

*Make ///sure ///the ///PI //// ///Co-Is ///are ///qualified

* ///Review ///studies ///at ///least ///once ///a ///year



Requirements ///of ///an ///IRB ///- ///verified ///answer(s)-✔✔* ///at ///least ///5 ///members

* ///one ///non-scientific ///member

* ///one ///non-institute ///member



What ///needs ///reported ///to ///the ///IRB? ///- ///verified ///answer(s)-✔✔*Changes //// ///deviations
///from ///protocol ///due ///to ///unforeseen ///hazard



* ///changes ///to ///subject ///risk

* ///adverse ///events

* ///new ///info ///that ///may ///impact ///subject ///safety

, Payment ///to ///subjects ///must ///be.... ///- ///verified ///answer(s)-✔✔prorated ///& ///not ///contingent
///on ///subject ///completing ///study




Investigator ///Responsibilities ///- ///verified ///answer(s)-✔✔*Maintain ///delegation ///long

*Ensure ///staff ///are ///trained/informed ///about ///the ///protocol ///(give ///delegated ///tasks)

* ///Ascertain ///reason ///study ///participant ///withdraws ///consent ///while ///respecting ///their
///privacy ///& ///rights



* ///Adhere ///to ///approved ///protocol

*Document ///& ///explain ///any ///deviations ///from ///approved ///protocol

* ///Process ///protocol ///amendments ///according ///to ///GCP

*Manage ///proper ///storage ///& ///care ///for ///trial ///devices/drugs. ///(PI ///can ///delegate ///this ///task
///to ///trained ///professional ///- ///PharmD, ///etc)




Protocol ///amendments ///should ///be ///submitted ///to ///- ///verified ///answer(s)-✔✔1. ///IRB

2. ///Sponsor

3. ///Regulatory ///Authority



Changes ///in ///risk ///to ///subjects... ///- ///verified ///answer(s)-✔✔should ///be ///included ///&
///approved ///on ///an ///updated ///ICF ///- ///patients ///enrolled ///should ///be ///re-consented




Consenting ///illiterate ///subjects ///- ///verified ///answer(s)-✔✔is ///okay, ///but ///must ///have
///impartial ///witness ///present




Necessary ///aspects ///of ///ICF ///- ///verified ///answer(s)-✔✔*Trial ///involves ///research

*Trial ///purposes

*Treatments ///- ///randomization ///aspect ///if ///applicable

* ///Procedures