Certified Clinical Research Professional (CCRP)
Exam | Correct Questions And Verified Answers
| Latest 2026
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 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 1 Clinical Trials - ,,,answer,,,..-Usually 20-80 subjects
-Meant to assess initial safety and efficacy
-Usually single center sites
Phase 2 Clinical Trials - ,,,answer,,,..-Usually no more than several
hundred subjects
-Multi-centered sites
Phase 3 Clinical Trials - ,,,answer,,,..-Confirmation of short-term efficacy
and establish long term efficacy
-Establish benefit-risk relationship
Exam | Correct Questions And Verified Answers
| Latest 2026
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 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 1 Clinical Trials - ,,,answer,,,..-Usually 20-80 subjects
-Meant to assess initial safety and efficacy
-Usually single center sites
Phase 2 Clinical Trials - ,,,answer,,,..-Usually no more than several
hundred subjects
-Multi-centered sites
Phase 3 Clinical Trials - ,,,answer,,,..-Confirmation of short-term efficacy
and establish long term efficacy
-Establish benefit-risk relationship
