CERTIFIED CLINICAL RESEARCH PROFESSIONAL
(CCRP) EXAM UPDATED ACTUAL QUESTIONS AND
CORRECT ANSWERS
Question:
1. When isn't an IND application needed?
Answer:
IND Application is not needed if investigation does not support change in labeling
Question:
2. What information must the general IND include? (21 CFR Part
312.23)
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)
Question:
3. How many days after FDA receives IND submission does the IND go into effect? (21 CFR
312.40)
Answer:
An IND goes into effect 30 days after the FDA receives the submission unless the FDA notifies the
Sponsor of a clinical hold
Question:
4. When must an IND amendment be submitted? (21 CFR Part
312.31)
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
, Question:
5. What are t he requirements for expanded access? (21 CFR Part
312.300 - Subpart 1)
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)
Question:
6. How many days does a Physician or Sponsor have to submit written summary of expanded access to the
FDA after use?
Answer:
15 days
Question:
7. 21 CFR Part 312.34
Answer:
Treatment use of an Investigational new drug
Question:
8. During which phases is a treatment protocol usually made available?
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
Question:
9. How long is the waiting period before a treatment IND study can be initiated?
Answer:
30 days
Question:
10. When will the FDA permit use of an investigational drug in widespread use?
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
Question:
11. What are the steps for withdrawing an IND? (21 CFR Part 312.38)
(CCRP) EXAM UPDATED ACTUAL QUESTIONS AND
CORRECT ANSWERS
Question:
1. When isn't an IND application needed?
Answer:
IND Application is not needed if investigation does not support change in labeling
Question:
2. What information must the general IND include? (21 CFR Part
312.23)
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)
Question:
3. How many days after FDA receives IND submission does the IND go into effect? (21 CFR
312.40)
Answer:
An IND goes into effect 30 days after the FDA receives the submission unless the FDA notifies the
Sponsor of a clinical hold
Question:
4. When must an IND amendment be submitted? (21 CFR Part
312.31)
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
, Question:
5. What are t he requirements for expanded access? (21 CFR Part
312.300 - Subpart 1)
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)
Question:
6. How many days does a Physician or Sponsor have to submit written summary of expanded access to the
FDA after use?
Answer:
15 days
Question:
7. 21 CFR Part 312.34
Answer:
Treatment use of an Investigational new drug
Question:
8. During which phases is a treatment protocol usually made available?
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
Question:
9. How long is the waiting period before a treatment IND study can be initiated?
Answer:
30 days
Question:
10. When will the FDA permit use of an investigational drug in widespread use?
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
Question:
11. What are the steps for withdrawing an IND? (21 CFR Part 312.38)
