Certified Clinical Research Professional (CCRP) Exam|
ALL QUESTIONS CORRECTLY ANSWERED
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
What are the steps for withdrawing an IND? (21 CFR Part 312.38) Correct Answer: A sponsor
may withdraw an IND at any time without prejudice by:
-Notifying the FDA
-Stopping all studies and notifying the investigators
-Returning all drug to the Sponsor, or destroying all drug as directed by Sponsor
-If the study is withdrawn for safety reasons, the Sponsor must notify investigators and the IRBs
Which form is used to certify absence of financial interest? Correct Answer: FDA Form 3454
What form is used for the mandatory reporting of serious adverse events? Correct Answer: FDA
Form 3500A
What is 21 CFR Part 50 Subpart D? Correct Answer: Additional Safeguards for Children in
Clinical Investigations
What is the FDA Form 482? Correct Answer: Notice of Inspection
What is 21 CFR Part 50.20 Subpart B? Correct Answer: General requirements for informed
consent
What steps must be taken if IND is put on clinical hold? (CFR Part 312.42) Correct Answer: -
Proposed study: Subjects may not be given the investigational drug
-Ongoing study: No recruiting of new subjects & subjects receiving investigational drug must
discontinue therapy unless specifically permitted by FDA in the interest of patient safety
What are the reasons for clinical hold? Correct Answer: -Exposure of unreasonable/significant
risk/injury to subjects
-Unqualified investigators (lack of scientific training/experience)
-Investigator brochure is misleading, erroneous, or incomplete
-IND does not contain sufficient information to assess risk to subjects of proposed studies
ALL QUESTIONS CORRECTLY ANSWERED
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
What are the steps for withdrawing an IND? (21 CFR Part 312.38) Correct Answer: A sponsor
may withdraw an IND at any time without prejudice by:
-Notifying the FDA
-Stopping all studies and notifying the investigators
-Returning all drug to the Sponsor, or destroying all drug as directed by Sponsor
-If the study is withdrawn for safety reasons, the Sponsor must notify investigators and the IRBs
Which form is used to certify absence of financial interest? Correct Answer: FDA Form 3454
What form is used for the mandatory reporting of serious adverse events? Correct Answer: FDA
Form 3500A
What is 21 CFR Part 50 Subpart D? Correct Answer: Additional Safeguards for Children in
Clinical Investigations
What is the FDA Form 482? Correct Answer: Notice of Inspection
What is 21 CFR Part 50.20 Subpart B? Correct Answer: General requirements for informed
consent
What steps must be taken if IND is put on clinical hold? (CFR Part 312.42) Correct Answer: -
Proposed study: Subjects may not be given the investigational drug
-Ongoing study: No recruiting of new subjects & subjects receiving investigational drug must
discontinue therapy unless specifically permitted by FDA in the interest of patient safety
What are the reasons for clinical hold? Correct Answer: -Exposure of unreasonable/significant
risk/injury to subjects
-Unqualified investigators (lack of scientific training/experience)
-Investigator brochure is misleading, erroneous, or incomplete
-IND does not contain sufficient information to assess risk to subjects of proposed studies
