CCRP EXAM REVIEW SHEET COMPLETE QUESTIONS ANSWERS GRADED A PLUS
CCRP Exam Questions and Answers Verified
Solutions Latest Update 2026/2027
Question:
What information must the general IND include? (21 CFR Part 312.23)
Answer:
Question:
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:
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:
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:
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:
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:
21 CFR Part 312.34
Answer:
Treatment use of an Investigational new drug
Question:
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
CCRP Exam Questions and Answers Verified
Solutions Latest Update 2026/2027
Question:
What information must the general IND include? (21 CFR Part 312.23)
Answer:
Question:
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:
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:
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:
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:
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:
21 CFR Part 312.34
Answer:
Treatment use of an Investigational new drug
Question:
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
