CCRP CERTIFICATION EVALUATION 2026
FULL SOLUTIONS PASSED GRADED A
⩥ What additional sections are commonly used by sponsors in
protocols? (8) Answer: 1) Table of contents
2) Study procedures
3) Data safety monitoring plan
4) Adverse events
5) Data quality assurance
6) Administrative considerations
7) References
8) Appendices
⩥ What 9 items should be included in the protocol "General
Information" section Answer: 1) Title
2) Protocol #
3) Date
4) Name/address of sponsor and monitor
5) People authorized to sign protocol
6) Name/contact for medical expert
7) Name/contact for sites
8) Name/contact for physicians responsible for medical decisions
,9) Name/contact for labs and other technical depts
⩥ What 8 items should be included in the "Background Information"
section of the protocol? Answer: 1) Name/desc of IP
2) Findings from nonclinical studies
3) Findings from clinical trials
4) Risks/benefits known
5) Route of admin, dosage, regimen and treatment period for IP
6) Statement of compliance with protocol, GCP and applicable
requirements
7) Desc of population to be studied
8) References to relevant lit that provide background
⩥ What 2 study designs are most commonly used in clinical trials?
Answer: 1) Parallel
2) Crossover
⩥ What 3 items do statisticians consider to evaluate sample size?
Answer: 1) Magnitude of IP effect expected between treatment arms
(Effect size)
2) Variability of outcome
3) Probability of observing effect (Power)
,⩥ How is power calculated? Answer: Using effect size and variability -
usually a higher # of subjects is needed for higher power
⩥ What are 2 methods used to reduce bias? Answer: 1) Blinding
2) Randomization
⩥ What are the 4 types of blinding? Answer: 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? Answer: 1)
Placebo
2) Standard of Care
3) Historical control
⩥ When is SOC used as opposed to placebo in clinical trials? Answer:
When placebo would be unethical and harmful to patients
⩥ When are historical controls used in a clinical trial? Answer: 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? Answer: 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? Answer: 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? 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
FULL SOLUTIONS PASSED GRADED A
⩥ What additional sections are commonly used by sponsors in
protocols? (8) Answer: 1) Table of contents
2) Study procedures
3) Data safety monitoring plan
4) Adverse events
5) Data quality assurance
6) Administrative considerations
7) References
8) Appendices
⩥ What 9 items should be included in the protocol "General
Information" section Answer: 1) Title
2) Protocol #
3) Date
4) Name/address of sponsor and monitor
5) People authorized to sign protocol
6) Name/contact for medical expert
7) Name/contact for sites
8) Name/contact for physicians responsible for medical decisions
,9) Name/contact for labs and other technical depts
⩥ What 8 items should be included in the "Background Information"
section of the protocol? Answer: 1) Name/desc of IP
2) Findings from nonclinical studies
3) Findings from clinical trials
4) Risks/benefits known
5) Route of admin, dosage, regimen and treatment period for IP
6) Statement of compliance with protocol, GCP and applicable
requirements
7) Desc of population to be studied
8) References to relevant lit that provide background
⩥ What 2 study designs are most commonly used in clinical trials?
Answer: 1) Parallel
2) Crossover
⩥ What 3 items do statisticians consider to evaluate sample size?
Answer: 1) Magnitude of IP effect expected between treatment arms
(Effect size)
2) Variability of outcome
3) Probability of observing effect (Power)
,⩥ How is power calculated? Answer: Using effect size and variability -
usually a higher # of subjects is needed for higher power
⩥ What are 2 methods used to reduce bias? Answer: 1) Blinding
2) Randomization
⩥ What are the 4 types of blinding? Answer: 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? Answer: 1)
Placebo
2) Standard of Care
3) Historical control
⩥ When is SOC used as opposed to placebo in clinical trials? Answer:
When placebo would be unethical and harmful to patients
⩥ When are historical controls used in a clinical trial? Answer: 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? Answer: 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? Answer: 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? 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
