CCRP Exam Questions and Answers 2026 |
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• What information must the general IND include? (21 CFR Part 312.23)
-✓✓FDA Form 1571:
-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 many days after FDA receives IND submission does the IND go
into effect? (21 CFR 312.40) -✓✓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? (21 CFR Part 312.31) -
✓✓-If there are changes to the protocol that affects safety of subjects,
scientific quality of the study, or scope of investigation
-If a new investigator is added to the study
-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 t he requirements for expanded access? (21 CFR Part
312.300 - Subpart 1) -✓✓-Population must have serious or life-
threatening disease or condition
-No comparable/significant alternate therapy/treatment
-Patient cannot obtain drug under another IND or protocol
-Potential benefit outweighs risks of treatment
-Expanded access won't interfere with completion of studies that could
support marketing approval
-Must apply to treatment protocols and should be for individual use (1
person)
• How many days does a Physician or Sponsor have to submit written
summary of expanded access to the FDA after use? -✓✓15 days
• 21 CFR Part 312.34 -✓✓Treatment use of an Investigational new drug
• During which phases is a treatment protocol usually made available? -
✓✓During Phase 3 but if data is compelling, may be available during
Phase 2, OR, after all clinical trials have been completed and Sponsor of
trials is awaiting/pursuing marketing approval
• How long is the waiting period before a treatment IND study can be
initiated? -✓✓30 days
• When will the FDA permit use of an investigational drug in
widespread use? -✓✓-If the criteria for expanded access are met
(benefits outweigh risk, illness is life threatening, or if no other
alternative treatments are available)
-If drug is being investigated in a controlled clinical trial under an IND
designed to support a marketing application for the expanded use or all
clinical trials are completed
• What are the steps for withdrawing an IND? (21 CFR Part 312.38) -
✓✓A sponsor may withdraw an IND at any time without prejudice by:
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• What information must the general IND include? (21 CFR Part 312.23)
-✓✓FDA Form 1571:
-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 many days after FDA receives IND submission does the IND go
into effect? (21 CFR 312.40) -✓✓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? (21 CFR Part 312.31) -
✓✓-If there are changes to the protocol that affects safety of subjects,
scientific quality of the study, or scope of investigation
-If a new investigator is added to the study
-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 t he requirements for expanded access? (21 CFR Part
312.300 - Subpart 1) -✓✓-Population must have serious or life-
threatening disease or condition
-No comparable/significant alternate therapy/treatment
-Patient cannot obtain drug under another IND or protocol
-Potential benefit outweighs risks of treatment
-Expanded access won't interfere with completion of studies that could
support marketing approval
-Must apply to treatment protocols and should be for individual use (1
person)
• How many days does a Physician or Sponsor have to submit written
summary of expanded access to the FDA after use? -✓✓15 days
• 21 CFR Part 312.34 -✓✓Treatment use of an Investigational new drug
• During which phases is a treatment protocol usually made available? -
✓✓During Phase 3 but if data is compelling, may be available during
Phase 2, OR, after all clinical trials have been completed and Sponsor of
trials is awaiting/pursuing marketing approval
• How long is the waiting period before a treatment IND study can be
initiated? -✓✓30 days
• When will the FDA permit use of an investigational drug in
widespread use? -✓✓-If the criteria for expanded access are met
(benefits outweigh risk, illness is life threatening, or if no other
alternative treatments are available)
-If drug is being investigated in a controlled clinical trial under an IND
designed to support a marketing application for the expanded use or all
clinical trials are completed
• What are the steps for withdrawing an IND? (21 CFR Part 312.38) -
✓✓A sponsor may withdraw an IND at any time without prejudice by:
