Certified Clinical Research Professional
(CCRP) Exam | 100% Correct Answers |
Verified | Latest 2024 Version
When isn't an IND application needed? - ✔✔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) - ✔✔
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:
(CCRP) Exam | 100% Correct Answers |
Verified | Latest 2024 Version
When isn't an IND application needed? - ✔✔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) - ✔✔
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:
