9/17/25, 10:52 AM SOCRA CCRP Exam Practice
SOCRA CCRP Certification EXAM Practice 2025/2026 Actual
Complete Real Exam Questions & Correct Well Elaborated
Answers |100% Verified solutions | Already Verified Test |
Already Graded A+ / 2025-2026 Brand New Exam!!
Terms in this set (147)
21 CFR part 11 regulates? Electronic Signatures
What is the name of FDA Inspectional Observation
Form 483?
What does 21CFR56 regulate? Institutional Review Boards
An application for 812
Investigational Device
Exemption is part of 21 CFR
part ?
A computer data compilation of any symbol or series of
Define Electronic Signature symbols executed, adopted, or authorized by an
individual to be legally binding equivalent of an
individual's
handwritten signature
True or False? 21CFR11.2, False. CFR part 11.2, subpart A is for electronic records
subpart A is only for maintenance when submitting to an agency and also
electronic records when not submitting to an agency.
required to be
maintained that must be
submitted to an agency.
What does 21CFR11, subpart B Electronic Records
/ 1/28
,9/17/25, 10:49 AM SOCRA CCRP Exa
cover?
What is another name for GCP (Good Clinical Practice)
ICH guideline is E6?
True. This regulation governs:
- Foods, including dietary supplements, that bear a
nutrient content claim or a health claim
- Infant formulas
True or False? 21CFR50
- Food and color additives
refers to protection of
- Drugs for human use
human rights that also
- Medical devices for human use
regulate food additives
- Biological products for human use
- Electronic products.
CFR part 50 section 312 Investigational New Drug
regulates?
When it comes to At least two; identification code and password
electronic signatures, how
many identification
components are required?
Please list examples:
In 21CFR50, subpart A, under Part 312
general provisions, which
part refers to an
investigational new drug?
IRB must register under which Department of Health and Human Services
federal department?
21CFR50 subpart B refers to Informed consent
____________________?
1. The human subject is confronted by a life-
threatening situation necessitating the use of the
List 4 requirements that make
informed test article.
consent feasible when a 2. Informed consent cannot be obtained from the
signature cannot be subject because of an inability to communicate with
obtained prior to the subject.
3. Time is not sufficient to obtain consent from the subject's LAR.
investigation listed in
4. There is no available alternative method of approved or
21CFR50: generally recognized
therapy that provides an equal or greater likelihood of saving the
life of the subject
/ 2/28
, 9/17/25, 10:49 AM SOCRA CCRP Exa
E:
ICH has four main Efficac
categories, under which all y S:
guidelines are found. Safety
Name these: Q:
Qualit
y
M: Multidisciplinary
What does 21CFR50 section Investigational Device Exemptions
812 regulate?
3. IRB/IEC
There are 8 ICH GCP 4. Investigator
guidelines. The first is the 5. Sponsor
glossary and the second is 6. Protocol and protocol amendments
7. Investigator's Brochure
the
8. Essential documents
principles of GCP. What are
the other 6 guidelines?
There are _ principles of ICH 13
GCP
In 21CFR50.24, when there Scientific Evidence
has been exception from
informed consent for
emergency research, the
proposed investigational plan
must be based on
_ _____________ in order for
this
exception to occur?
What is the name of FDA Form Notice of Inspection
482?
True or False? The rights, True
safety and well- being of
the trial subjects are the
most
important consideration and
should
prevails over the interests of
science and society
All principles of GCP are The Declaration of Helsinki
conducted in accordance
/ 3/28
SOCRA CCRP Certification EXAM Practice 2025/2026 Actual
Complete Real Exam Questions & Correct Well Elaborated
Answers |100% Verified solutions | Already Verified Test |
Already Graded A+ / 2025-2026 Brand New Exam!!
Terms in this set (147)
21 CFR part 11 regulates? Electronic Signatures
What is the name of FDA Inspectional Observation
Form 483?
What does 21CFR56 regulate? Institutional Review Boards
An application for 812
Investigational Device
Exemption is part of 21 CFR
part ?
A computer data compilation of any symbol or series of
Define Electronic Signature symbols executed, adopted, or authorized by an
individual to be legally binding equivalent of an
individual's
handwritten signature
True or False? 21CFR11.2, False. CFR part 11.2, subpart A is for electronic records
subpart A is only for maintenance when submitting to an agency and also
electronic records when not submitting to an agency.
required to be
maintained that must be
submitted to an agency.
What does 21CFR11, subpart B Electronic Records
/ 1/28
,9/17/25, 10:49 AM SOCRA CCRP Exa
cover?
What is another name for GCP (Good Clinical Practice)
ICH guideline is E6?
True. This regulation governs:
- Foods, including dietary supplements, that bear a
nutrient content claim or a health claim
- Infant formulas
True or False? 21CFR50
- Food and color additives
refers to protection of
- Drugs for human use
human rights that also
- Medical devices for human use
regulate food additives
- Biological products for human use
- Electronic products.
CFR part 50 section 312 Investigational New Drug
regulates?
When it comes to At least two; identification code and password
electronic signatures, how
many identification
components are required?
Please list examples:
In 21CFR50, subpart A, under Part 312
general provisions, which
part refers to an
investigational new drug?
IRB must register under which Department of Health and Human Services
federal department?
21CFR50 subpart B refers to Informed consent
____________________?
1. The human subject is confronted by a life-
threatening situation necessitating the use of the
List 4 requirements that make
informed test article.
consent feasible when a 2. Informed consent cannot be obtained from the
signature cannot be subject because of an inability to communicate with
obtained prior to the subject.
3. Time is not sufficient to obtain consent from the subject's LAR.
investigation listed in
4. There is no available alternative method of approved or
21CFR50: generally recognized
therapy that provides an equal or greater likelihood of saving the
life of the subject
/ 2/28
, 9/17/25, 10:49 AM SOCRA CCRP Exa
E:
ICH has four main Efficac
categories, under which all y S:
guidelines are found. Safety
Name these: Q:
Qualit
y
M: Multidisciplinary
What does 21CFR50 section Investigational Device Exemptions
812 regulate?
3. IRB/IEC
There are 8 ICH GCP 4. Investigator
guidelines. The first is the 5. Sponsor
glossary and the second is 6. Protocol and protocol amendments
7. Investigator's Brochure
the
8. Essential documents
principles of GCP. What are
the other 6 guidelines?
There are _ principles of ICH 13
GCP
In 21CFR50.24, when there Scientific Evidence
has been exception from
informed consent for
emergency research, the
proposed investigational plan
must be based on
_ _____________ in order for
this
exception to occur?
What is the name of FDA Form Notice of Inspection
482?
True or False? The rights, True
safety and well- being of
the trial subjects are the
most
important consideration and
should
prevails over the interests of
science and society
All principles of GCP are The Declaration of Helsinki
conducted in accordance
/ 3/28
