Certified Clinical Research Professional (CCRP) Exam 100% Correct
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Course
CCRP
Institution
CCRP
When isn't an IND application needed? - 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) - ANSWER FDA Form 1571:
-FDA Form 1571 cover sheet
-Table of contents
-Investigative plan
-Inv...
Certified Clinical Research Professional
(CCRP) Exam 100% Correct
When isn't an IND application needed? - 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) - 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) -
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) - 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 form is used for the mandatory reporting of serious adverse events? - ANSWER FDA Form 3500A
What is 21 CFR Part 50 Subpart D? - ANSWER Additional Safeguards for Children in Clinical Investigations
What is the FDA Form 482? - ANSWER Notice of Inspection
What is 21 CFR Part 50.20 Subpart B? - ANSWER General requirements for informed consent
What steps must be taken if IND is put on clinical hold? (CFR Part 312.42) - 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? - 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
Phase 2 Clinical Trials - ANSWER -Usually no more than several hundred subjects
-Multi-centered sites
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