©FYNDLAY 2025 ALL RIGHTS RESERVED
Certified Clinical Research Professional
(CCRP) Exam Questions and Answers 100%
Pass
When is an IND Application not needed? - ANS IND Application is not needed if the
investigation does not support a change in labeling
What must the General IND include? - ANS -FDA Form 1571 cover sheet
-Table of contents
-Investigative plan
-Investigator's brochure
-Protocol
-Chemistry/Manufacturing information
-Pharmacology/toxicology
-Previous human research/literature information
-Additional information (drug dependence and abuse potential)
How long after FDA receives IND submission does the IND go into effect? - ANS An IND goes
into effect 30 days after the FDA receives the submission unless the FDA notifies the Sponsor of
a clinical hold
When must an IND amendment be submitted? - ANS -If there are changes to the protocol
that affect the safety of subjects, scientific quality of the study, or scope of investigation
-If a new investigator is added to the study
©FYNDLAY 1
, ©FYNDLAY 2025 ALL RIGHTS RESERVED
-Information amendments must be submitted for chemistry/microbiology, pharm/toxicology,
or clinical
OTHER SUBMISSIONS:
--IND safety reports
--Response to clinical hold
--Response to FDA request for information
--IRB Annual report
What are the requirements for Expanded Access? - ANS -Population must have a serious or
life-threatening disease or condition
-No comparable/significant alternate therapy/treatment
-Patient cannot obtain the drug under another IND or protocol
-Potential benefit outweighs risks of treatment
-Expanded access won't interfere with the completion of studies that could support marketing
approval
-Must apply to treatment protocols and should be for individual use (1 person)
How many days to submit a written summary of Expanded Access to the FDA after use? -
ANS 15 days
21 CFR Part 312.34 - ANS Treatment use of an Investigational New Drug
During which phases is a treatment protocol usually made available? - ANS During Phase 3
but if data is compelling, may be available during Phase 2, OR, after all clinical trials have been
completed and the Sponsor of trials is awaiting/pursuing marketing approval
How long is the waiting period before a treatment IND study can be initiated? - ANS 30 days
When will the FDA permit the use of an investigational drug in widespread use? - ANS -If the
criteria for expanded access are met (benefits outweigh risk, illness is life-threatening, or if no
other alternative treatments are available)
©FYNDLAY 2
Certified Clinical Research Professional
(CCRP) Exam Questions and Answers 100%
Pass
When is an IND Application not needed? - ANS IND Application is not needed if the
investigation does not support a change in labeling
What must the General IND include? - ANS -FDA Form 1571 cover sheet
-Table of contents
-Investigative plan
-Investigator's brochure
-Protocol
-Chemistry/Manufacturing information
-Pharmacology/toxicology
-Previous human research/literature information
-Additional information (drug dependence and abuse potential)
How long after FDA receives IND submission does the IND go into effect? - ANS An IND goes
into effect 30 days after the FDA receives the submission unless the FDA notifies the Sponsor of
a clinical hold
When must an IND amendment be submitted? - ANS -If there are changes to the protocol
that affect the safety of subjects, scientific quality of the study, or scope of investigation
-If a new investigator is added to the study
©FYNDLAY 1
, ©FYNDLAY 2025 ALL RIGHTS RESERVED
-Information amendments must be submitted for chemistry/microbiology, pharm/toxicology,
or clinical
OTHER SUBMISSIONS:
--IND safety reports
--Response to clinical hold
--Response to FDA request for information
--IRB Annual report
What are the requirements for Expanded Access? - ANS -Population must have a serious or
life-threatening disease or condition
-No comparable/significant alternate therapy/treatment
-Patient cannot obtain the drug under another IND or protocol
-Potential benefit outweighs risks of treatment
-Expanded access won't interfere with the completion of studies that could support marketing
approval
-Must apply to treatment protocols and should be for individual use (1 person)
How many days to submit a written summary of Expanded Access to the FDA after use? -
ANS 15 days
21 CFR Part 312.34 - ANS Treatment use of an Investigational New Drug
During which phases is a treatment protocol usually made available? - ANS During Phase 3
but if data is compelling, may be available during Phase 2, OR, after all clinical trials have been
completed and the Sponsor of trials is awaiting/pursuing marketing approval
How long is the waiting period before a treatment IND study can be initiated? - ANS 30 days
When will the FDA permit the use of an investigational drug in widespread use? - ANS -If the
criteria for expanded access are met (benefits outweigh risk, illness is life-threatening, or if no
other alternative treatments are available)
©FYNDLAY 2
