Certified Clinical Research Professional (CCRP) Exam questions
and answers 2025\2026 A+ Grade
When isn't an IND application needed?
- correct answer IND Application is not needed if investigation does not support change in labeling
What information must the general IND include? (21 CFR Part 312.23)
- correct answer 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)
- correct answer 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)
- correct answer -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)
- correct answer -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?
- correct answer 15 days
21 CFR Part 312.34
- correct answer Treatment use of an Investigational new drug
During which phases is a treatment protocol usually made available?
- correct answer 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?
- correct answer 30 days
When will the FDA permit use of an investigational drug in widespread use?
- correct answer -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
and answers 2025\2026 A+ Grade
When isn't an IND application needed?
- correct answer IND Application is not needed if investigation does not support change in labeling
What information must the general IND include? (21 CFR Part 312.23)
- correct answer 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)
- correct answer 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)
- correct answer -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)
- correct answer -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?
- correct answer 15 days
21 CFR Part 312.34
- correct answer Treatment use of an Investigational new drug
During which phases is a treatment protocol usually made available?
- correct answer 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?
- correct answer 30 days
When will the FDA permit use of an investigational drug in widespread use?
- correct answer -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
