CCRP Complete Study Guide/ 223Q&A/ 2025 With
Correct Answers.
21 CFR Part 11 - Correct Answer--Electronic Records; Electronic Signatures
21 CFR 50 - Correct Answer--Protection of Human Subjets/Informed Consent
21 CFR 56 - Correct Answer--Institutional Review Boards
21 CFR 312 - Correct Answer--Investigational New Drug Application
21 CFR 812 - Correct Answer--Investigational Device Exemptions
Biometrics - Correct Answer--A method of verifying an individual's identity based on measurement of
the individual's physical features or repeatable actions where those features and or actions are both
unique to that individual and measurable (21 CFR 11)
Closed System - Correct Answer--An environment in which system access is controlled by persons who
are responsible for the content of electronic records that are on the system (21 CFR 11)
Digital Signature - Correct Answer--An electronic signature based upon cryptographic methods of
originator authentication, computer by using a set of rules and a set of parameters such that the identity
of the signer and the integrity of the data can be verified (21 CFR 11)
Electronic Signature - Correct Answer--A computer data compilation of any symbol or series of symbols
executed, adopted, or authorized by an individual to be legally binding equivalent of the handwritten
signature (21 CFR 11)
Open System - Correct Answer--An environment in which system access is not controlled by persons who
are responsible for the content of electronic records that are on the system (21 CFR 11)
,Minimal Risk - Correct Answer--The probability and magnitude of harm or discomfort anticipated in the
research are not greater in and of themselves than those ordinarily encountered in daily life or during
the performance of routine physical or psychological examinations or tests
Assent - Correct Answer--A child's affirmative agreement to participate in a clinical investigation
Elements of Informed Consent (8) - Correct Answer--1. Statement that the study involved research,
Explanation of the purpose, Expected duration, Description & Identification of procedures
2. Description of any reasonably foreseeable risks or discomforts
3. Description of any benefits
4. Disclosure of appropriate alternative procedures
5. Statement describing extent of confidentiality of records identifying subject will be maintained
6. Research involving more than minimal risk: Whether any compensation is available & Explanation
whether medical treatments are available if injury occurs
7. Explanation of whom to contact for research questions
8. Statement participation is voluntary
(21 CFR 50)
Additional Elements of Informed Consent (6) - Correct Answer--1. Treatment or procedure may involve
risks to the subject
2. Circumstances under which participation may be terminated by the investigator
3. Additional costs to the subject
4. Consequences of withdrawal
5. Significant new findings developed during course of research will be provided to the subject
6. Approximate number of subjects involved
(21 CFR 50)
, Exceptions from General Requirements of ICF - Correct Answer--1. Life-threatening situation
necessitating use of test article
2. Inability to communicate with subject
3. Time is not sufficient to obtain
4. No alternative method of approved therapy that provides an equal of greater likelihood of saving the
life of the subject
(21 CFR 50)
Exceptions from ICF Requirements for Emergency Research - Correct Answer--1. Life-threatening
situation
2. Obtaining is not feasible due to medical condition
3. Participation holds out prospect of direct benefit
4. Could not practicably be carried out without waiver
5. Proposed investigational plan defines the length of potential therapeutic window & committed to
contact a LAR
6. IRB reviewed and approved ICF procedures
(21 CFR 50)
IRB must retain records for ___ years after completion of clinical investigation. - Correct Answer--3
Informed Consent shall be documented by___. - Correct Answer--the use of a written consent form
approved by an IRB and signed and dated by the subject or representative at the time of consent. A copy
shall be given to the subject (21 CFR 50)
Short Form ICF - Correct Answer--Written consent document stating that the elements of informed
consent have been presented orally to the subject or subject's LAR (21 CFR 50)
Short Form ICF Documentation Requirements - Correct Answer--1. Witness to the oral presentation
2. IRB approved written summary
3. Short form to be signed by the subject or subject's LAR
Correct Answers.
21 CFR Part 11 - Correct Answer--Electronic Records; Electronic Signatures
21 CFR 50 - Correct Answer--Protection of Human Subjets/Informed Consent
21 CFR 56 - Correct Answer--Institutional Review Boards
21 CFR 312 - Correct Answer--Investigational New Drug Application
21 CFR 812 - Correct Answer--Investigational Device Exemptions
Biometrics - Correct Answer--A method of verifying an individual's identity based on measurement of
the individual's physical features or repeatable actions where those features and or actions are both
unique to that individual and measurable (21 CFR 11)
Closed System - Correct Answer--An environment in which system access is controlled by persons who
are responsible for the content of electronic records that are on the system (21 CFR 11)
Digital Signature - Correct Answer--An electronic signature based upon cryptographic methods of
originator authentication, computer by using a set of rules and a set of parameters such that the identity
of the signer and the integrity of the data can be verified (21 CFR 11)
Electronic Signature - Correct Answer--A computer data compilation of any symbol or series of symbols
executed, adopted, or authorized by an individual to be legally binding equivalent of the handwritten
signature (21 CFR 11)
Open System - Correct Answer--An environment in which system access is not controlled by persons who
are responsible for the content of electronic records that are on the system (21 CFR 11)
,Minimal Risk - Correct Answer--The probability and magnitude of harm or discomfort anticipated in the
research are not greater in and of themselves than those ordinarily encountered in daily life or during
the performance of routine physical or psychological examinations or tests
Assent - Correct Answer--A child's affirmative agreement to participate in a clinical investigation
Elements of Informed Consent (8) - Correct Answer--1. Statement that the study involved research,
Explanation of the purpose, Expected duration, Description & Identification of procedures
2. Description of any reasonably foreseeable risks or discomforts
3. Description of any benefits
4. Disclosure of appropriate alternative procedures
5. Statement describing extent of confidentiality of records identifying subject will be maintained
6. Research involving more than minimal risk: Whether any compensation is available & Explanation
whether medical treatments are available if injury occurs
7. Explanation of whom to contact for research questions
8. Statement participation is voluntary
(21 CFR 50)
Additional Elements of Informed Consent (6) - Correct Answer--1. Treatment or procedure may involve
risks to the subject
2. Circumstances under which participation may be terminated by the investigator
3. Additional costs to the subject
4. Consequences of withdrawal
5. Significant new findings developed during course of research will be provided to the subject
6. Approximate number of subjects involved
(21 CFR 50)
, Exceptions from General Requirements of ICF - Correct Answer--1. Life-threatening situation
necessitating use of test article
2. Inability to communicate with subject
3. Time is not sufficient to obtain
4. No alternative method of approved therapy that provides an equal of greater likelihood of saving the
life of the subject
(21 CFR 50)
Exceptions from ICF Requirements for Emergency Research - Correct Answer--1. Life-threatening
situation
2. Obtaining is not feasible due to medical condition
3. Participation holds out prospect of direct benefit
4. Could not practicably be carried out without waiver
5. Proposed investigational plan defines the length of potential therapeutic window & committed to
contact a LAR
6. IRB reviewed and approved ICF procedures
(21 CFR 50)
IRB must retain records for ___ years after completion of clinical investigation. - Correct Answer--3
Informed Consent shall be documented by___. - Correct Answer--the use of a written consent form
approved by an IRB and signed and dated by the subject or representative at the time of consent. A copy
shall be given to the subject (21 CFR 50)
Short Form ICF - Correct Answer--Written consent document stating that the elements of informed
consent have been presented orally to the subject or subject's LAR (21 CFR 50)
Short Form ICF Documentation Requirements - Correct Answer--1. Witness to the oral presentation
2. IRB approved written summary
3. Short form to be signed by the subject or subject's LAR
