SOCRA CERTIFICATION EXAM 2025 WITH ACCURATE SOLUTIONS- GRADED A+
Biometrics
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, Sec. 11.3)
Closed System
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, Sec. 11.3)
Digital Signature
An electronic signature based upon cryptographic methods of originator authentication,
computed 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, Sec. 11.3)
Electronic Record
Any combination of text, graphics, data, audio, pictorial, or other information
representation in digital form that is created, modified, maintained, archived, retrieved or
distributed by a computer system. (21 CFR, Sec. 11.3)
Electronic Signature
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, Sec. 11.3)
,Open system
An environment in which system access is not controlled by persons who are responsible
for the content of the electronic records that are on the system. (21 CFR, Sec. 11.3)
Children
Persons who have not attained the legal age for consent to treatment or procedures
involved in clinical investigations, under the applicable law of the jurisdiction in which the
clinical investigation will be conducted. (21 CFR, sec. 50.3)
Parent
A child's biological or adoptive parent. (21 CFR, sec. 50.3)
Ward
A child who is placed in legal custody of the State or other agency, institution, or entity,
consistent with applicable Federal, State or Local law. (21 CFR, sec. 50.3)
Permission
The agreement of the parent(s) or guardian to the participation of their child or ward in a
clinical investigation. Permission must be obtained in compliance with part 50 subpart B
and must include all the elements of the informed consent. (21 CFR, sec. 50.3)
Guardian
, An individual who is authorized under applicable State or local law to consent on behalf of
a child to general medical care when general medical care includes research. (21 CFR, sec.
50.3)
Emergency Use
The use of a test article on a human subject in a life-threatening situation in which no
standard acceptable treatment is available, and in which there is no sufficient time to
obtain IRB approval. (21 CFR, sec. 56.102)
IRB Approval
The determination of the IRB that the clinical investigation has been reviewed and may be
conducted at an institution within the constraints set forth by the IRB and by other
institutional and federal Requirements. (21 CFR, sec. 56.102)
Contract Research Organization
A person that assumes, as an independent contractor with the sponsor, one or more of the
obligations of a sponsor, e.g., design of a protocol, selection or monitoring of
investigations, evaluation of reports, and preparation of materials to be submitted to the
FDA. (21 CFR, sec. 312.3)
Independent Ethics Committee (IEC)
An independent body (a review board or a committee, institutional, regional, national or
supranational), constitutes fo medical professionals and non-medical members, whose
responsibility it is to ensure the protection of the rights, safety and well-being of human
subjects involved in a trial and to provide public assurance of that protection, by, among,
other things, reviewing and approving/providing favourable opinion on, the trial protocol,
the suitability of the investigators, facilities, and the methods and material to be used in
obtaining and documenting informed consent of the trial subjects. (ICH GCP E6 1.27)
Biometrics
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, Sec. 11.3)
Closed System
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, Sec. 11.3)
Digital Signature
An electronic signature based upon cryptographic methods of originator authentication,
computed 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, Sec. 11.3)
Electronic Record
Any combination of text, graphics, data, audio, pictorial, or other information
representation in digital form that is created, modified, maintained, archived, retrieved or
distributed by a computer system. (21 CFR, Sec. 11.3)
Electronic Signature
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, Sec. 11.3)
,Open system
An environment in which system access is not controlled by persons who are responsible
for the content of the electronic records that are on the system. (21 CFR, Sec. 11.3)
Children
Persons who have not attained the legal age for consent to treatment or procedures
involved in clinical investigations, under the applicable law of the jurisdiction in which the
clinical investigation will be conducted. (21 CFR, sec. 50.3)
Parent
A child's biological or adoptive parent. (21 CFR, sec. 50.3)
Ward
A child who is placed in legal custody of the State or other agency, institution, or entity,
consistent with applicable Federal, State or Local law. (21 CFR, sec. 50.3)
Permission
The agreement of the parent(s) or guardian to the participation of their child or ward in a
clinical investigation. Permission must be obtained in compliance with part 50 subpart B
and must include all the elements of the informed consent. (21 CFR, sec. 50.3)
Guardian
, An individual who is authorized under applicable State or local law to consent on behalf of
a child to general medical care when general medical care includes research. (21 CFR, sec.
50.3)
Emergency Use
The use of a test article on a human subject in a life-threatening situation in which no
standard acceptable treatment is available, and in which there is no sufficient time to
obtain IRB approval. (21 CFR, sec. 56.102)
IRB Approval
The determination of the IRB that the clinical investigation has been reviewed and may be
conducted at an institution within the constraints set forth by the IRB and by other
institutional and federal Requirements. (21 CFR, sec. 56.102)
Contract Research Organization
A person that assumes, as an independent contractor with the sponsor, one or more of the
obligations of a sponsor, e.g., design of a protocol, selection or monitoring of
investigations, evaluation of reports, and preparation of materials to be submitted to the
FDA. (21 CFR, sec. 312.3)
Independent Ethics Committee (IEC)
An independent body (a review board or a committee, institutional, regional, national or
supranational), constitutes fo medical professionals and non-medical members, whose
responsibility it is to ensure the protection of the rights, safety and well-being of human
subjects involved in a trial and to provide public assurance of that protection, by, among,
other things, reviewing and approving/providing favourable opinion on, the trial protocol,
the suitability of the investigators, facilities, and the methods and material to be used in
obtaining and documenting informed consent of the trial subjects. (ICH GCP E6 1.27)
