ACRP-CP LATEST
CERTIFICATION
EXAM
If a person is in a life threatening situation that necessitates the test
article: and they/their LAR cannot provide consent... what must the PI
do to properly enroll the subj per required measures described in the
protocol? - ANSWERS-Receive documented approval/favorable opinion
by the IRB/IEC prior to enrollment. Then ensure the subjs LAR is
informed asap to continue the consent
Pre-Trial Meetings Discuss - ANSWERS-1. subject availability
2. competing studies
3. lab requirements
4. sponsor expectations
DSMB (Data and Safety Monitoring Board) - ANSWERS-1. Assesses
the progress of a clinical trial: the safety data: and the critical efficacy
endpoints
2. Can recommend that sponsors modify: end: or continue a trial. But
cannot recommend they start a new trial
Incapacitated subjects can provide consent as soon as capacity is
regained (T/F) - ANSWERS-True
END OF
PAGE
1
, ACRP-CP LATEST
CERTIFICATION
EXAM
The signature page is a required section of the IB - ANSWERS-False
All trial phases assess safety (T/F) - ANSWERS-True
Focuses on safety and dose in healthy subjects
Determine metabolic and pharmacologic action of the drug in humans
Investigates human pharmacology
The most typical study
Initial administration or IND into humans - ANSWERS-Phase I
Focuses on efficacy and side effects in subjects of that specific
indication
A study which seeks to determine the ideal dose and regimen of a new
IP to treat the indicated condition - ANSWERS-Phase II
Compares new tx to existing tx for that indication
END OF
PAGE
2
, ACRP-CP LATEST
CERTIFICATION
EXAM
A study which seeks to evaluate the IP to similar treatment options or
placebo if there are no current tx's for the indication
Determines therapeutic benefit and is done in a larger: specific
population. Can be reffered to as a therapeutic confirmatory trial: pivotol
trial: or comparative efficacy trial - ANSWERS-Phase III *
*Phase III trials usually have fewer subjects than Phase IV trials
Therapeutic use: begins after drug approval
Tx is approved and available: but still evaluating for long term effects
Phase IV trials usually require more subjects and data collection than
phase III trials - ANSWERS-Phase IV
Post Market - ANSWERS--Analysis conducted after drug approval aka
Phase IV: -Provides the most significant amount of safety and efficacy
in pediatrics trials with ltd. Number of participants
Pediatric Trials - ANSWERS--can be prepared for by developing a
program for use in children: - experience with use in children so far
should be included in the development plan: -conduct
END OF
PAGE
3
, ACRP-CP LATEST
CERTIFICATION
EXAM
pharmacodynamic/pharmacokinetic studies in children if there is no
relevant information available from similar compounds
Study design must include - ANSWERS--clear endpoints: -Appropriate
comparators: -Adequate # of subjects
All SAE's must be life-threatening to be considered an SAE opposed to
AE (T/F) - ANSWERS-True
Any changes to an IB are not required to be submitted to the IRB/IEC
(T/F) - ANSWERS-False. changes to safety language must be submitted
to the IRB
Prior to archiving a study: where should documentation of site IP
destruction be filed? - ANSWERS-in the study files of the PI and
Sponsor
Centralized monitoring supports clinical data review by examining data
trends (T/F) - ANSWERS-True
END OF
PAGE
4
CERTIFICATION
EXAM
If a person is in a life threatening situation that necessitates the test
article: and they/their LAR cannot provide consent... what must the PI
do to properly enroll the subj per required measures described in the
protocol? - ANSWERS-Receive documented approval/favorable opinion
by the IRB/IEC prior to enrollment. Then ensure the subjs LAR is
informed asap to continue the consent
Pre-Trial Meetings Discuss - ANSWERS-1. subject availability
2. competing studies
3. lab requirements
4. sponsor expectations
DSMB (Data and Safety Monitoring Board) - ANSWERS-1. Assesses
the progress of a clinical trial: the safety data: and the critical efficacy
endpoints
2. Can recommend that sponsors modify: end: or continue a trial. But
cannot recommend they start a new trial
Incapacitated subjects can provide consent as soon as capacity is
regained (T/F) - ANSWERS-True
END OF
PAGE
1
, ACRP-CP LATEST
CERTIFICATION
EXAM
The signature page is a required section of the IB - ANSWERS-False
All trial phases assess safety (T/F) - ANSWERS-True
Focuses on safety and dose in healthy subjects
Determine metabolic and pharmacologic action of the drug in humans
Investigates human pharmacology
The most typical study
Initial administration or IND into humans - ANSWERS-Phase I
Focuses on efficacy and side effects in subjects of that specific
indication
A study which seeks to determine the ideal dose and regimen of a new
IP to treat the indicated condition - ANSWERS-Phase II
Compares new tx to existing tx for that indication
END OF
PAGE
2
, ACRP-CP LATEST
CERTIFICATION
EXAM
A study which seeks to evaluate the IP to similar treatment options or
placebo if there are no current tx's for the indication
Determines therapeutic benefit and is done in a larger: specific
population. Can be reffered to as a therapeutic confirmatory trial: pivotol
trial: or comparative efficacy trial - ANSWERS-Phase III *
*Phase III trials usually have fewer subjects than Phase IV trials
Therapeutic use: begins after drug approval
Tx is approved and available: but still evaluating for long term effects
Phase IV trials usually require more subjects and data collection than
phase III trials - ANSWERS-Phase IV
Post Market - ANSWERS--Analysis conducted after drug approval aka
Phase IV: -Provides the most significant amount of safety and efficacy
in pediatrics trials with ltd. Number of participants
Pediatric Trials - ANSWERS--can be prepared for by developing a
program for use in children: - experience with use in children so far
should be included in the development plan: -conduct
END OF
PAGE
3
, ACRP-CP LATEST
CERTIFICATION
EXAM
pharmacodynamic/pharmacokinetic studies in children if there is no
relevant information available from similar compounds
Study design must include - ANSWERS--clear endpoints: -Appropriate
comparators: -Adequate # of subjects
All SAE's must be life-threatening to be considered an SAE opposed to
AE (T/F) - ANSWERS-True
Any changes to an IB are not required to be submitted to the IRB/IEC
(T/F) - ANSWERS-False. changes to safety language must be submitted
to the IRB
Prior to archiving a study: where should documentation of site IP
destruction be filed? - ANSWERS-in the study files of the PI and
Sponsor
Centralized monitoring supports clinical data review by examining data
trends (T/F) - ANSWERS-True
END OF
PAGE
4
