UPDATED Exam Questions and
CORRECT Answers
Pre-clinical Studies - CORRECT ANSWER - purpose is to determine safe starting dose for
humans
Folic Acid - CORRECT ANSWER - Positive effect on kids w/ lymphoblastic leukemia
Clinical trials - CORRECT ANSWER - comparing 2+ therapeutic tx in ctl setting to
evaluate effect of intervention of specific disease/s
Clinical Trial phase 1 - CORRECT ANSWER - how much can you handle before
breakdown?
determine max tolerated dose of drug or drug combo.
ID dose-limiting toxicities: highest dose for which incidence of dose limiting toxicities is <33%
Clinical Trial Phase 1 Patient - CORRECT ANSWER - advanced disease, good organ
function, resistant to standard therapies
Clinical Trial phase 2 - CORRECT ANSWER - determines efficacy of new agent in tx of
specific cancer types and validate toxicity & dosage data. info r/t drug administration, acute
toxicity, & supporting care
Clinical Trial phase 2 Patient - CORRECT ANSWER - pt who show little to no response
to prior tx usually selected w/ normal organ function, measurable tumor size, reasonable life
expectancy & functional status.
Includes pt who have not been treated w/ investigational drug
, Clinical Trial Phase 3 - CORRECT ANSWER - determine value of agent r/t existing tx.
Measure response, toxicity, survival & QOL
Clinical trial Phase 3 Patient - CORRECT ANSWER - large number of newly dx who
receive tx and observed over long period of time
Clinical Trial Phase 4 - CORRECT ANSWER - Occurs after agent is available in
commercial market. Efforts to decrease AE, toxicity w/ acceptable cure rate. Focuses more on
long term safety
Institutional Review Board - CORRECT ANSWER - Ensures the rights/welfare of humans
are protected, by signing informed consent and requires documentation of eligibility, tx,
modifications, toxicities, and outcome
informed consent - CORRECT ANSWER - requires enough information to make decisions
consistent w/ cultural, spiritual, & psychosocial values.
purpose/duration/procedures, participant rights, possible benefits, probable risks, alternative
therapies, confidentiality stmt, stmt for voluntary participation
nursing role - CORRECT ANSWER - verify consent, information provided, educational
materials, radiographic/lab studies completed prior to tx, dose/schedule, drug rx, collect lab
specimens, document start/stop times, pt response, instruct family to report rx
pharmacokinetics - CORRECT ANSWER - movement of drug in body: absorption,
distribution, metabolism, excretion. consider how it varies person to person and dose to dose
wide therapeutic range - CORRECT ANSWER - dosage required to achieve efficacy in
large % pt is lower than dosage expected to produce AE
narrow therapeutic range - CORRECT ANSWER - ex. anticancer meds
dosage required to achieve efficacy is not very much lower than dosage that may result in life-
threatening toxicities or AE