CCRP UPDATED ACTUAL Exam Questions and CORRECT Answers | Solved and Verified | 100% Accurate

CCRP UPDATED ACTUAL Exam Questions and CORRECT Answers
| Solved and Verified | 100% Accurate

Question 1.
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)


Question 2.
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


Question 3.
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) -✓✓-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 4.
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


Question 5.
21 CFR Part 312.34

Correct Answer: Treatment use of an Investigational new drug

, Question 6.
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


Question 7.
How long is the waiting period before a treatment IND study can be initiated?

Correct Answer: 30 days


Question 8.
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


Question 9.
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


Question 10.
Which form is used to certify absence of financial interest?

Correct Answer: FDA Form 3454


Question 11.
What form is used for the mandatory reporting of serious adverse events?

Correct Answer: FDA Form 3500A


Question 12.
What is 21 CFR Part 50 Subpart D?

Correct Answer: Additional Safeguards for Children in Clinical Investigations