CCRP ACTUAL 2026 CORE EXAM TEST QUESTIONS AND
SOLUTIONS RATED A+
✔✔What are the 4 types of blinding? - ✔✔1) Triple blind: sponsor/investigator/subjects
are blinded
2) Double blind: investigator/subjects blinded
3) Single blind: subjects blinded
4) Open label: no blinding
✔✔What are the 3 types of control groups used in trials? - ✔✔1) Placebo
2) Standard of Care
3) Historical control
✔✔When is SOC used as opposed to placebo in clinical trials? - ✔✔When placebo
would be unethical and harmful to patients
✔✔When are historical controls used in a clinical trial? - ✔✔When other controls aren't
practical or ethical; but similarity between patients in historical control group and current
treatment group is important
✔✔What are historical controls? - ✔✔Prior data from similar patients with the disease to
be studied, or data from same patient in crossover study
✔✔What 9 items does ICH GCP guideline recommend be included in Trial Design
section? - ✔✔1) Primary/secondary endpts
2) Type/design of trial
3) Measures to avoid bias
4) Treatments - dose, packaging, regimen
5) Duration of participation
6) Stopping rules
7) Accountability procedures for IP
8) Maintenance of randomization codes
9) Data to be recorded on CRFs/source data
✔✔What 4 items should be included in a protocol to describe Withdrawal criteria? -
✔✔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2) Type/timing of data collection for withdrawn subjects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4) Follow up for subjects withdrawn from IP treatment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? - ✔✔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? - ✔✔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? - ✔✔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? -
✔✔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? - ✔✔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? - ✔✔1) Data recording, handling and record keeping
2) Study monitoring
3) Auditing and direct access to source data/documents
✔✔What 3 items should be included in the Administrative Considerations section of the
protocol? - ✔✔1) Ethical assurance
2) Publication rights
3) Financing and insurance
✔✔What is the definition of an investigator per FDA regulations? - ✔✔Individual who
actually conducts a clinical investigation. If investigation is conducted by a team, the
investigator is the responsible leader of the team. (21 CFR 312.3)
✔✔What is the definition of a sub-investigator per FDA regulations? - ✔✔Any other
individual member of the clinical investigator's team
✔✔What are the responsibilities of an investigator per 21 CFR 312.60? (6) - ✔✔1)
Conduct investigation per signed investigator statement
, 2) Conduct investigation per investigational plan
3) Conduct investigation per applicable regulations
4) Protect rights, safety and welfare of subjects
5) Control IP
6) Obtain informed consent
✔✔What 8 items does an investigator commit to when they sign a Form FDA 1572? -
✔✔1) Conduct according to current protocol
2) Personally conduct/supervise the studies
3) Obtain informed consent
4) Report AEs
5) Properly train staff
6) Maintain adequate records
7) Ensure IRB complies with 21 CFR 56
8) Comply with all other requirements in 21 CFR 312
✔✔What is the device study equivalent of an FDA 1572? - ✔✔Investigator Agreement
✔✔What are an investigator's responsibilities regarding the protocol? (3) - ✔✔1)
Develop study protocol and content in compliance with ICH GCP (may also be sponsor)
2) Conduct trial in accordance with protocol per FDA 1572
3) Submit protocol changes to IRB prior to implementation
✔✔What are an investigator's responsibilities regarding informed consent and
recruitment? (7) - ✔✔1) Develop ICFs that contain the basic and additional elements of
informed consent per 21 CFR 50
2) Follow IRB requirements for consent, not necessarily sponsor's
3) ICF and recruitment materials approved by IRB prior to use per 21 CFR 56
4) Obtain legally effective informed consent
5) Provide subject sufficient opportunity to decide
6) Minimize possibility of coercion or undue influence
7) Avoid exculpatory language through which subject waives any legal rights regarding
liability/negligence
✔✔What are an investigator's responsibilities regarding safety reports for drug studies?
(3) - ✔✔1) Report SAEs, whether or not considered drug-related, to sponsor
immediately after discovery (21 CFR 312)
2) Report SAEs to reviewing IRB promptly upon discovery (21 CFR 56 and 312)
3) Record and report non-serious adverse events to sponsor per protocol
✔✔What are an investigator's responsibilities regarding safety reports for device
studies? (1) - ✔✔Report UADEs to sponsor and reviewing IRB as soon as possible, but
no later than 10 working days after discovery (21 CFR 812)
SOLUTIONS RATED A+
✔✔What are the 4 types of blinding? - ✔✔1) Triple blind: sponsor/investigator/subjects
are blinded
2) Double blind: investigator/subjects blinded
3) Single blind: subjects blinded
4) Open label: no blinding
✔✔What are the 3 types of control groups used in trials? - ✔✔1) Placebo
2) Standard of Care
3) Historical control
✔✔When is SOC used as opposed to placebo in clinical trials? - ✔✔When placebo
would be unethical and harmful to patients
✔✔When are historical controls used in a clinical trial? - ✔✔When other controls aren't
practical or ethical; but similarity between patients in historical control group and current
treatment group is important
✔✔What are historical controls? - ✔✔Prior data from similar patients with the disease to
be studied, or data from same patient in crossover study
✔✔What 9 items does ICH GCP guideline recommend be included in Trial Design
section? - ✔✔1) Primary/secondary endpts
2) Type/design of trial
3) Measures to avoid bias
4) Treatments - dose, packaging, regimen
5) Duration of participation
6) Stopping rules
7) Accountability procedures for IP
8) Maintenance of randomization codes
9) Data to be recorded on CRFs/source data
✔✔What 4 items should be included in a protocol to describe Withdrawal criteria? -
✔✔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? - ✔✔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? - ✔✔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? - ✔✔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? -
✔✔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? - ✔✔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? - ✔✔1) Data recording, handling and record keeping
2) Study monitoring
3) Auditing and direct access to source data/documents
✔✔What 3 items should be included in the Administrative Considerations section of the
protocol? - ✔✔1) Ethical assurance
2) Publication rights
3) Financing and insurance
✔✔What is the definition of an investigator per FDA regulations? - ✔✔Individual who
actually conducts a clinical investigation. If investigation is conducted by a team, the
investigator is the responsible leader of the team. (21 CFR 312.3)
✔✔What is the definition of a sub-investigator per FDA regulations? - ✔✔Any other
individual member of the clinical investigator's team
✔✔What are the responsibilities of an investigator per 21 CFR 312.60? (6) - ✔✔1)
Conduct investigation per signed investigator statement
, 2) Conduct investigation per investigational plan
3) Conduct investigation per applicable regulations
4) Protect rights, safety and welfare of subjects
5) Control IP
6) Obtain informed consent
✔✔What 8 items does an investigator commit to when they sign a Form FDA 1572? -
✔✔1) Conduct according to current protocol
2) Personally conduct/supervise the studies
3) Obtain informed consent
4) Report AEs
5) Properly train staff
6) Maintain adequate records
7) Ensure IRB complies with 21 CFR 56
8) Comply with all other requirements in 21 CFR 312
✔✔What is the device study equivalent of an FDA 1572? - ✔✔Investigator Agreement
✔✔What are an investigator's responsibilities regarding the protocol? (3) - ✔✔1)
Develop study protocol and content in compliance with ICH GCP (may also be sponsor)
2) Conduct trial in accordance with protocol per FDA 1572
3) Submit protocol changes to IRB prior to implementation
✔✔What are an investigator's responsibilities regarding informed consent and
recruitment? (7) - ✔✔1) Develop ICFs that contain the basic and additional elements of
informed consent per 21 CFR 50
2) Follow IRB requirements for consent, not necessarily sponsor's
3) ICF and recruitment materials approved by IRB prior to use per 21 CFR 56
4) Obtain legally effective informed consent
5) Provide subject sufficient opportunity to decide
6) Minimize possibility of coercion or undue influence
7) Avoid exculpatory language through which subject waives any legal rights regarding
liability/negligence
✔✔What are an investigator's responsibilities regarding safety reports for drug studies?
(3) - ✔✔1) Report SAEs, whether or not considered drug-related, to sponsor
immediately after discovery (21 CFR 312)
2) Report SAEs to reviewing IRB promptly upon discovery (21 CFR 56 and 312)
3) Record and report non-serious adverse events to sponsor per protocol
✔✔What are an investigator's responsibilities regarding safety reports for device
studies? (1) - ✔✔Report UADEs to sponsor and reviewing IRB as soon as possible, but
no later than 10 working days after discovery (21 CFR 812)
