CCRP EXAM WITH VERIFIED QUESTIONS
AND ANSWERS|| GUARANTEED PASS||
ALREADY GRADED A+|| LATEST VERSION
2026
What are the 4 types of incidences that require an IND safety report for drug
studies? - ANSWER-1) Serious and unexpected suspected adverse reactions
2) Findings from other studies that suggest significant risk in humans
3) Findings from animal/in-vitro testing that suggest significant risk in humans
4) Increased rate of occurrence of serious suspected adverse reaction from
previous protocol/IB
What are 3 examples of SUSARs for drug studies? - ANSWER-1) Single
occurrence of event that is known to be strongly associated with IP
2) 1+ occurrences of event not commonly associated with drug but otherwise
uncommon in population
3) Aggregate analysis of events such as known consequences of disease that
commonly occur in population but occur more frequently in IP treatment group
In what 4 ways can an IND safety report be submitted for drug studies? -
ANSWER-1) Narrative document
2) FDA Form 3500A
3) Electronic format that FDA can process, review, archive
,4) Council for International Organziations of Medical Sciences Form (for
foreign reactions)
What must a sponsor do if the FDA requests more information about an IND
safety report for drug studies? - ANSWER-Respond no more than 15 calendar
days from receipt of request
What type of findings must be reported in narrative format in IND safety reports
for drug studies? - ANSWER-Overall findings or pooled analyses from
published and unpublished, in-vitro, animal, epidemiological or clinical studies
Within what timeline must a sponsor notify the FDA of a fatal or life-
threatening SUSAR for drug studies? - ANSWER-Up to 7 calendar days
How soon must a sponsor conduct investigations of Unanticipated Adverse
Device Effects? - ANSWER-21 CFR 812.46(b) - immediately
What 5 incidences must sponsors report to the FDA and/or investigators? -
ANSWER-1) UADEs
2) Withdrawal of IRB approval
3) Withdrawal of FDA approval
4) Recall and device disposition
5) Significant risk device determination
How many days does a sponsor have to submit a report to the
FDA/investigators/IRBs about withdrawal of IRB approval? - ANSWER-5
working days
How many days does a sponsor have to submit a report to investigators/IRB
about withdrawal of FDA approval? - ANSWER-5 working days
,How many days does a sponsor have to submit a report to
FDA/investigators/IRB about returns, repairs or disposal of units of a device? -
ANSWER-Notice to be provided within 30 days after request was made - to
include rationale
How many days does a sponsor have to submit a report to FDA about SR device
if sponsor suggested NSR? - ANSWER-5 working days
What FDA regulations govern continuing review reports? - ANSWER-21 CFR
312.33
21 CFR 812.150(b)(5)
When must a sponsor submit a brief report of investigation progress to FDA for
drug trials? - ANSWER-Within 60 days of anniversary date that IND went into
effect
What 4 items should be included in a protocol to describe Withdrawal criteria? -
ANSWER-1) When/how to withdraw subjects
2) Type/timing of data collection for withdrawn subjects
3) Whether subjects will be replaced
4) Follow up for subjects withdrawn from IP treatment
What 5 items should be included in the "Treatment of Subjects" section of the
protocol? - ANSWER-1) Name, dose, regimen, route of admin and treatment
period for IP
2) Meds/treatments not permitted before and during trial
3) Procedures for monitoring subject compliance
4) IP storage and accountability
5) Return/destruction of IP
, What is a DSMB? - ANSWER-Group of experts that review research data to
ensure subject safety and data validity per a DSMPlan
What 3 items should be discussed in a DSMP? - ANSWER-1) Procedures for
DSMB to oversee progress
2) Plans for DSMB to assure data accuracy and protocol compliance
3) How DSMB will review reporting of UAPs, AEs to sponsor, FDA and IRB
What 4 items should be included in the Adverse Events section of the protocol?
- ANSWER-1) Safety parameters
2) Methods/timing for assessing, recording and analyzing safety parameters
3) Procedures for reporting and recording AEs and illnesses
4) Type/duration of followup for AEs
What are the 7 items that should be included in the Statistics section of the
protocol? - ANSWER-1) Stat methods + interim analyses
2) # of subjects to be enrolled
3) Level of significance
4) Criteria for termination
5) Procedure for accounting of missing, unused and spurious data
6) Reporting deviations from plan
7) Selection of subjects to be included in analysis
What 3 items should be included in the Data Quality Assurance section of the
protocol? - ANSWER-1) Data recording, handling and record keeping
2) Study monitoring
3) Auditing and direct access to source data/documents
AND ANSWERS|| GUARANTEED PASS||
ALREADY GRADED A+|| LATEST VERSION
2026
What are the 4 types of incidences that require an IND safety report for drug
studies? - ANSWER-1) Serious and unexpected suspected adverse reactions
2) Findings from other studies that suggest significant risk in humans
3) Findings from animal/in-vitro testing that suggest significant risk in humans
4) Increased rate of occurrence of serious suspected adverse reaction from
previous protocol/IB
What are 3 examples of SUSARs for drug studies? - ANSWER-1) Single
occurrence of event that is known to be strongly associated with IP
2) 1+ occurrences of event not commonly associated with drug but otherwise
uncommon in population
3) Aggregate analysis of events such as known consequences of disease that
commonly occur in population but occur more frequently in IP treatment group
In what 4 ways can an IND safety report be submitted for drug studies? -
ANSWER-1) Narrative document
2) FDA Form 3500A
3) Electronic format that FDA can process, review, archive
,4) Council for International Organziations of Medical Sciences Form (for
foreign reactions)
What must a sponsor do if the FDA requests more information about an IND
safety report for drug studies? - ANSWER-Respond no more than 15 calendar
days from receipt of request
What type of findings must be reported in narrative format in IND safety reports
for drug studies? - ANSWER-Overall findings or pooled analyses from
published and unpublished, in-vitro, animal, epidemiological or clinical studies
Within what timeline must a sponsor notify the FDA of a fatal or life-
threatening SUSAR for drug studies? - ANSWER-Up to 7 calendar days
How soon must a sponsor conduct investigations of Unanticipated Adverse
Device Effects? - ANSWER-21 CFR 812.46(b) - immediately
What 5 incidences must sponsors report to the FDA and/or investigators? -
ANSWER-1) UADEs
2) Withdrawal of IRB approval
3) Withdrawal of FDA approval
4) Recall and device disposition
5) Significant risk device determination
How many days does a sponsor have to submit a report to the
FDA/investigators/IRBs about withdrawal of IRB approval? - ANSWER-5
working days
How many days does a sponsor have to submit a report to investigators/IRB
about withdrawal of FDA approval? - ANSWER-5 working days
,How many days does a sponsor have to submit a report to
FDA/investigators/IRB about returns, repairs or disposal of units of a device? -
ANSWER-Notice to be provided within 30 days after request was made - to
include rationale
How many days does a sponsor have to submit a report to FDA about SR device
if sponsor suggested NSR? - ANSWER-5 working days
What FDA regulations govern continuing review reports? - ANSWER-21 CFR
312.33
21 CFR 812.150(b)(5)
When must a sponsor submit a brief report of investigation progress to FDA for
drug trials? - ANSWER-Within 60 days of anniversary date that IND went into
effect
What 4 items should be included in a protocol to describe Withdrawal criteria? -
ANSWER-1) When/how to withdraw subjects
2) Type/timing of data collection for withdrawn subjects
3) Whether subjects will be replaced
4) Follow up for subjects withdrawn from IP treatment
What 5 items should be included in the "Treatment of Subjects" section of the
protocol? - ANSWER-1) Name, dose, regimen, route of admin and treatment
period for IP
2) Meds/treatments not permitted before and during trial
3) Procedures for monitoring subject compliance
4) IP storage and accountability
5) Return/destruction of IP
, What is a DSMB? - ANSWER-Group of experts that review research data to
ensure subject safety and data validity per a DSMPlan
What 3 items should be discussed in a DSMP? - ANSWER-1) Procedures for
DSMB to oversee progress
2) Plans for DSMB to assure data accuracy and protocol compliance
3) How DSMB will review reporting of UAPs, AEs to sponsor, FDA and IRB
What 4 items should be included in the Adverse Events section of the protocol?
- ANSWER-1) Safety parameters
2) Methods/timing for assessing, recording and analyzing safety parameters
3) Procedures for reporting and recording AEs and illnesses
4) Type/duration of followup for AEs
What are the 7 items that should be included in the Statistics section of the
protocol? - ANSWER-1) Stat methods + interim analyses
2) # of subjects to be enrolled
3) Level of significance
4) Criteria for termination
5) Procedure for accounting of missing, unused and spurious data
6) Reporting deviations from plan
7) Selection of subjects to be included in analysis
What 3 items should be included in the Data Quality Assurance section of the
protocol? - ANSWER-1) Data recording, handling and record keeping
2) Study monitoring
3) Auditing and direct access to source data/documents
