CCRP COMPREHENSIVE EXAM UPDATED QUESTIONS AND
SOLUTIONS RATED A+
✔✔1) PK and toxicokinetic
2) Single dose toxicity
3) Repeated dose toxicity
4) Local tolerance
5) Genotoxicity
6) Carcinogenicity
7) Reproduction toxicity
8) Supplemental studies if needed - ✔✔Types of Non-Clinical Studies (Animal Trials)
✔✔Study that investigates the mode of action and/or effects of a drug substance in
relation to its desired therapeutic target - ✔✔Primary Pharmacodynamic Studies
✔✔Studies that investigate the mode of action and/or effects of a drug substance not
related to its desire therapeutic target - ✔✔Secondary Pharmacodynamic Studies
✔✔Blood Pressure
Heart Rate
ECG/EKG
Repolarization/conductance abnormalities - ✔✔Core Battery for Cardiovascular System
✔✔Respiratory Rate
Functional Assessments (tidal volume, hgb Oxygen saturation) - ✔✔Core Battery for
Respiratory System
✔✔Motor activity
behavioral changes
coordination
sensory/motor reflex response
temperature - ✔✔Core Battery for Central Nervous System
✔✔Investigational New Drug Application
FDA - ✔✔Before clinical trials can be initiated, an application containing the appropriate
information must be submitted to regulatory authorities, in the USA this is called XXXX
and submitted to the XXX (21 CFR Part 312)
✔✔Unapproved drug to be shipped lawfully for the purpose of conducting investigations
of the drug - ✔✔An IND permits what? (21 CFR Part 312)
✔✔Assuring the safety and rights of subjects - ✔✔FDA's primary objective in all phases
of development is...
,✔✔Phase II and III - ✔✔These phase of trials, the FDA helps assure the quality of the
scientific evaluation is adequate to permit evaluation of the drugs safety and efficacy (21
CFR Part 312)
✔✔The FDA - ✔✔Who determines if Phase II/III studies are likely to yield data capable
of meeting regulatory standards for marketing approval?
✔✔1) Novelty of drug
2)Extent the drug has been studied previously
3) Known of suspected risks
4) Phase of development - ✔✔IND information depends on the amount of information
available, these 4 things are: (21 CFR Part 312)
✔✔General Investigational Plan
Protocols for specific human studies - ✔✔Initial IND should focus on (21 CFR Part 312)
✔✔Build logically on previous submissions
Be supported by additional information such as animal studies and other human studies
- ✔✔Amendments to IND with new or revised protocols (21 CFR Part 312)
✔✔Cover Sheet (FDA Form 1571)
Table of Contents
Introductory statement
investigator's brochure
protocol (s)
Chemistry and manufacturing information
pharm and tox information
previous human experience with investigational drug - ✔✔A Sponsor Initiated IND must
contain (21 CFR Part 312)
✔✔30 Days, unless FDA notifies sponsor of clinical hold
Upon earlier notification, investigations may begin - ✔✔How long does it take for an IND
to go into effect? (21 CFR Part 312)
✔✔1) To facilitate the availability of promising new drugs available to desperately ill
patients as early in the drug development process as possible, before general
marketing begins
2)To obtain additional data on the drug's safety and effectiveness - ✔✔The purpose of
Treatment Use of Investigational Drug (21 CFR Part 312)
✔✔1) The drug is intended to treat a serious or immediately life threatening disease
2) No comparable or satisfactory alternative drug/therapy is available to treat the stage
of disease in the intended patient population - ✔✔A treatment protocol or IND may be
filed if: ((21 CFR Part 312)
, ✔✔Phase II/ III trials or
After all the clinical trials have been completed and the sponsor of the controlled clinical
trial is actively pursuing marketing approval of the drug with due dilligence - ✔✔A
treatment protocol or IND are usually found in what phase of trials?
✔✔30-Day Waiting Period - ✔✔How long is the waiting period before the study can
initiate after the treatment IND is submitted?
✔✔Need for investigational drug arises in an emergency situation
Insufficient time to allow for submission of an IND or a treatment IND
Request for specified use by telephone or other rapid means of communication -
✔✔Emergency use of an investigational product (21 CFR Part 312)
✔✔5 Working Days - ✔✔How quickly must a site notify the IRB of an emergency use of
investigational drug? (21 CFR Part 312)
✔✔1) Notifying the FDA
2) Stopping all studies and notifying the investigators
3)All drug returned to the sponsor or destroyed as directed by sponsor
4)If withdrawn due to safety reasons, the sponsor must notify the investigators and the
IRBs of those reasons - ✔✔Sponsors have the right with withdraw an IND at anytime,
without prejudice by completing the following: (21 CFR Part 312)
✔✔An order issued by the FDA to the sponsor to delay a proposed clinical investigation
or to suspend an ongoing investigation - ✔✔What is a "Clinical Hold"
✔✔Subjects may not be given the investigational drug - ✔✔What does a FDA "Clinical
Hold" mean for a proposed study?
✔✔no new subjects may be given the IP and subjects already taking the drug should be
discontinued unless continuation is specifically permitted by the FDA - ✔✔What does a
FDA "Clinical Hold" mean for an ongoing study?
✔✔1) Subjects exposed to unreasonable risk, illness or injury
2)Clinical investigators are not qualified
3)Investigator's brochure is misleading, inaccurate or materially incomplete
4)The IND does not contain sufficient information to assess risk to subjects -
✔✔Grounds for FDA Clinical Hold in Phase 1 Trials
✔✔1) All grounds related to holds in Phase 1 trials AND
2) The protocol is clearly deficient in design to meet the stated objects - ✔✔Grounds for
FDA Clinical Hold in Phase II/III Trials
SOLUTIONS RATED A+
✔✔1) PK and toxicokinetic
2) Single dose toxicity
3) Repeated dose toxicity
4) Local tolerance
5) Genotoxicity
6) Carcinogenicity
7) Reproduction toxicity
8) Supplemental studies if needed - ✔✔Types of Non-Clinical Studies (Animal Trials)
✔✔Study that investigates the mode of action and/or effects of a drug substance in
relation to its desired therapeutic target - ✔✔Primary Pharmacodynamic Studies
✔✔Studies that investigate the mode of action and/or effects of a drug substance not
related to its desire therapeutic target - ✔✔Secondary Pharmacodynamic Studies
✔✔Blood Pressure
Heart Rate
ECG/EKG
Repolarization/conductance abnormalities - ✔✔Core Battery for Cardiovascular System
✔✔Respiratory Rate
Functional Assessments (tidal volume, hgb Oxygen saturation) - ✔✔Core Battery for
Respiratory System
✔✔Motor activity
behavioral changes
coordination
sensory/motor reflex response
temperature - ✔✔Core Battery for Central Nervous System
✔✔Investigational New Drug Application
FDA - ✔✔Before clinical trials can be initiated, an application containing the appropriate
information must be submitted to regulatory authorities, in the USA this is called XXXX
and submitted to the XXX (21 CFR Part 312)
✔✔Unapproved drug to be shipped lawfully for the purpose of conducting investigations
of the drug - ✔✔An IND permits what? (21 CFR Part 312)
✔✔Assuring the safety and rights of subjects - ✔✔FDA's primary objective in all phases
of development is...
,✔✔Phase II and III - ✔✔These phase of trials, the FDA helps assure the quality of the
scientific evaluation is adequate to permit evaluation of the drugs safety and efficacy (21
CFR Part 312)
✔✔The FDA - ✔✔Who determines if Phase II/III studies are likely to yield data capable
of meeting regulatory standards for marketing approval?
✔✔1) Novelty of drug
2)Extent the drug has been studied previously
3) Known of suspected risks
4) Phase of development - ✔✔IND information depends on the amount of information
available, these 4 things are: (21 CFR Part 312)
✔✔General Investigational Plan
Protocols for specific human studies - ✔✔Initial IND should focus on (21 CFR Part 312)
✔✔Build logically on previous submissions
Be supported by additional information such as animal studies and other human studies
- ✔✔Amendments to IND with new or revised protocols (21 CFR Part 312)
✔✔Cover Sheet (FDA Form 1571)
Table of Contents
Introductory statement
investigator's brochure
protocol (s)
Chemistry and manufacturing information
pharm and tox information
previous human experience with investigational drug - ✔✔A Sponsor Initiated IND must
contain (21 CFR Part 312)
✔✔30 Days, unless FDA notifies sponsor of clinical hold
Upon earlier notification, investigations may begin - ✔✔How long does it take for an IND
to go into effect? (21 CFR Part 312)
✔✔1) To facilitate the availability of promising new drugs available to desperately ill
patients as early in the drug development process as possible, before general
marketing begins
2)To obtain additional data on the drug's safety and effectiveness - ✔✔The purpose of
Treatment Use of Investigational Drug (21 CFR Part 312)
✔✔1) The drug is intended to treat a serious or immediately life threatening disease
2) No comparable or satisfactory alternative drug/therapy is available to treat the stage
of disease in the intended patient population - ✔✔A treatment protocol or IND may be
filed if: ((21 CFR Part 312)
, ✔✔Phase II/ III trials or
After all the clinical trials have been completed and the sponsor of the controlled clinical
trial is actively pursuing marketing approval of the drug with due dilligence - ✔✔A
treatment protocol or IND are usually found in what phase of trials?
✔✔30-Day Waiting Period - ✔✔How long is the waiting period before the study can
initiate after the treatment IND is submitted?
✔✔Need for investigational drug arises in an emergency situation
Insufficient time to allow for submission of an IND or a treatment IND
Request for specified use by telephone or other rapid means of communication -
✔✔Emergency use of an investigational product (21 CFR Part 312)
✔✔5 Working Days - ✔✔How quickly must a site notify the IRB of an emergency use of
investigational drug? (21 CFR Part 312)
✔✔1) Notifying the FDA
2) Stopping all studies and notifying the investigators
3)All drug returned to the sponsor or destroyed as directed by sponsor
4)If withdrawn due to safety reasons, the sponsor must notify the investigators and the
IRBs of those reasons - ✔✔Sponsors have the right with withdraw an IND at anytime,
without prejudice by completing the following: (21 CFR Part 312)
✔✔An order issued by the FDA to the sponsor to delay a proposed clinical investigation
or to suspend an ongoing investigation - ✔✔What is a "Clinical Hold"
✔✔Subjects may not be given the investigational drug - ✔✔What does a FDA "Clinical
Hold" mean for a proposed study?
✔✔no new subjects may be given the IP and subjects already taking the drug should be
discontinued unless continuation is specifically permitted by the FDA - ✔✔What does a
FDA "Clinical Hold" mean for an ongoing study?
✔✔1) Subjects exposed to unreasonable risk, illness or injury
2)Clinical investigators are not qualified
3)Investigator's brochure is misleading, inaccurate or materially incomplete
4)The IND does not contain sufficient information to assess risk to subjects -
✔✔Grounds for FDA Clinical Hold in Phase 1 Trials
✔✔1) All grounds related to holds in Phase 1 trials AND
2) The protocol is clearly deficient in design to meet the stated objects - ✔✔Grounds for
FDA Clinical Hold in Phase II/III Trials
