MEGA SOCRA CCRP Exam Content with complete
solutions (Verified Answers) | Latest 2023/2024
Impartial Witness - ansA person, who is independent of the trial, who cannot be
unfairly influenced by people involved with the trial, who attends the informed
consent process if the subject or the subject's LAR cannot read, and who reads the
informaed consent for, and any other written information supplied to the subject.
(ICH GCP E6 1.26)
Implant - ansA device that is placed into a surgically or naturally formed cavity of the
human body if it is intended to remain there for a period of 30 days or more. (21 CFR,
sec. 812.3)
IND - ansAn investigational new drug application. Is synonymous with "Notice of
Claimed Investigational Exemption for a New Drug". (21 CFR, sec. 312.3)
Independent Data Monitoring Committee (IDMC) - ansMay be established by the
sponsor to assess at intervals the progress of a clinical trial, the safety data, and the
critical efficacy endpoints. (ICH GCP E6 1.25)
Independent Ethics Committee (IEC) - ansA review panel the is responsible for
ensuring the protection of the rights, safety, and well-being of human subjects
involved in a clinical investigation and is adequately constituted to provide
assurance of that protection. An IRB is one type of IEC. (21 CFR, sec. 312.3)
Independent Ethics Committee (IEC) - ansAn 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)
Informed Consent ADDITIONAL Elements: - ans- risk to embyro or fetus
- termination procedures
- costs to study subjects
- approximate number of study subjects
- a statement of new findings when they may impact a subject's willingness to
participate
Informed Consent MUST Contain: - ans- explanation of purpose of research
- duration of participation
- description of procedures to be followed
- identification of any procedures which are experimental
, MEGA SOCRA CCRP Exam Content with complete
solutions (Verified Answers) | Latest 2023/2024
- any foreseeable risks or discomfort
- statement about potential benefits to subjects
- statement if no reasonable alternative procedures or treatments are available to
subjects
- for > minimal risk, a statement about compensation and if medical treatment is
available for injuries
- statement of who to contact in the event of research-related injury
Inspection - ansThe act by a regulatory authority of conducting and official review of
documents, facilities, records and any other resources that are deemed by the
authorities to be related to the clinical trial and that may be located at the site of the
trial, at the sponsor's and/or contract research organizations (CROs) facilities, or at
other establishments deemed appropriate by the regulatory authorities. (ICH GCP E6
1.29)
Institution - ansAny public or private entity or agency (including Federal, State or
other agencies). The word facility as used in section 520(g) of the Act is deemed to
by synonymous with the term institution for purposes of this part.(21 CFR, sec. 50.3)
Institutional Review Board (IRB) - ansAny board, committee, or other group formally
designated by an institution to review biomedical research involving humans as
subjects, to approve the initiation of and conduct periodic review of such research.
The term has the same meaning as the phrase institutional review committee as
used in section 520(g) of the act. (21 CFR, sec. 50.3)
Interim Clinical Trial/Study Report - ansA report of intermediate results and their
evaluation based on analyses performed during the course of the trial. (ICH GCP E6
1.32)
Investigational Device - ansA device, including a transitional device that is the
object of investigation. (21 CFR, sec. 812.3)
Investigational Product - ansA pharmaceutical form of an active ingredient or
placebo being tested or used as a reference in a clinical trail, including a product
with a marketing authorization when used or assembled in a different way from the
approved form, or when used for an unapproved indication, or when used to gain
further information about an approved use. (ICH GCP E6 1.33)
Investigator - ansAn individual who actually conducts a clinical investigation, i.e.,
under whose immediate direction the test article is administered or dispensed to, or
used involving, a subject, or, in the event of an investigation conducted by a team of
individuals, is the responsible leader of that team. (21 CFR, sec. 50.3)
solutions (Verified Answers) | Latest 2023/2024
Impartial Witness - ansA person, who is independent of the trial, who cannot be
unfairly influenced by people involved with the trial, who attends the informed
consent process if the subject or the subject's LAR cannot read, and who reads the
informaed consent for, and any other written information supplied to the subject.
(ICH GCP E6 1.26)
Implant - ansA device that is placed into a surgically or naturally formed cavity of the
human body if it is intended to remain there for a period of 30 days or more. (21 CFR,
sec. 812.3)
IND - ansAn investigational new drug application. Is synonymous with "Notice of
Claimed Investigational Exemption for a New Drug". (21 CFR, sec. 312.3)
Independent Data Monitoring Committee (IDMC) - ansMay be established by the
sponsor to assess at intervals the progress of a clinical trial, the safety data, and the
critical efficacy endpoints. (ICH GCP E6 1.25)
Independent Ethics Committee (IEC) - ansA review panel the is responsible for
ensuring the protection of the rights, safety, and well-being of human subjects
involved in a clinical investigation and is adequately constituted to provide
assurance of that protection. An IRB is one type of IEC. (21 CFR, sec. 312.3)
Independent Ethics Committee (IEC) - ansAn 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)
Informed Consent ADDITIONAL Elements: - ans- risk to embyro or fetus
- termination procedures
- costs to study subjects
- approximate number of study subjects
- a statement of new findings when they may impact a subject's willingness to
participate
Informed Consent MUST Contain: - ans- explanation of purpose of research
- duration of participation
- description of procedures to be followed
- identification of any procedures which are experimental
, MEGA SOCRA CCRP Exam Content with complete
solutions (Verified Answers) | Latest 2023/2024
- any foreseeable risks or discomfort
- statement about potential benefits to subjects
- statement if no reasonable alternative procedures or treatments are available to
subjects
- for > minimal risk, a statement about compensation and if medical treatment is
available for injuries
- statement of who to contact in the event of research-related injury
Inspection - ansThe act by a regulatory authority of conducting and official review of
documents, facilities, records and any other resources that are deemed by the
authorities to be related to the clinical trial and that may be located at the site of the
trial, at the sponsor's and/or contract research organizations (CROs) facilities, or at
other establishments deemed appropriate by the regulatory authorities. (ICH GCP E6
1.29)
Institution - ansAny public or private entity or agency (including Federal, State or
other agencies). The word facility as used in section 520(g) of the Act is deemed to
by synonymous with the term institution for purposes of this part.(21 CFR, sec. 50.3)
Institutional Review Board (IRB) - ansAny board, committee, or other group formally
designated by an institution to review biomedical research involving humans as
subjects, to approve the initiation of and conduct periodic review of such research.
The term has the same meaning as the phrase institutional review committee as
used in section 520(g) of the act. (21 CFR, sec. 50.3)
Interim Clinical Trial/Study Report - ansA report of intermediate results and their
evaluation based on analyses performed during the course of the trial. (ICH GCP E6
1.32)
Investigational Device - ansA device, including a transitional device that is the
object of investigation. (21 CFR, sec. 812.3)
Investigational Product - ansA pharmaceutical form of an active ingredient or
placebo being tested or used as a reference in a clinical trail, including a product
with a marketing authorization when used or assembled in a different way from the
approved form, or when used for an unapproved indication, or when used to gain
further information about an approved use. (ICH GCP E6 1.33)
Investigator - ansAn individual who actually conducts a clinical investigation, i.e.,
under whose immediate direction the test article is administered or dispensed to, or
used involving, a subject, or, in the event of an investigation conducted by a team of
individuals, is the responsible leader of that team. (21 CFR, sec. 50.3)
