SOCRA CERTIFICATION EXAM SCRIPT 2026
COMPLETE QUESTIONS AND SOLUTIONS
GRADED A+
⩥ Inspection. Answer: The 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)
⩥ Interim Clinical Trial/Study Report. Answer: A report of intermediate
results and their evaluation based on analyses performed during the
course of the trial. (ICH GCP E6 1.32)
⩥ Investigational Product. Answer: A 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's Brochure. Answer: A compilation of the clinical and
nonclinical data on the investigational products which is relevant to the
, study of the investigational products in human subjects. (ICH GCP E6
1.36)
⩥ Legally Acceptable Representative. Answer: An individual or
juridicial or other body authorized under applicable law to consent, on
behalf of a prospective subject, to the subjects participation in the
clinical trial. (ICH GCP E6 1.37)
⩥ Monitoring Report. Answer: A written report from the monitor or
sponsor after each site visit and/or other trial-related communication
according to the sponsor's SOPs. (ICH GCP E6 1.39)
⩥ Multicentre Trial. Answer: A clinical trial conducted according to a
single protocol but at more than one site, and therefore, carried out by
more than one investigator. (ICH GCP E6 1.40)
⩥ Nonclinical Study. Answer: Biomedical studies not performed on
human subjects. (ICH GCP E6 1.41)
⩥ Protocol Amendment. Answer: A written description of changes to or
formal clarification of a protocol. (ICH GCP E6 1.45)
⩥ Quality Assurance (QA). Answer: All those planned and systematic
actions that are established to ensure that the trial is performed and the
data are generated, documented, and reported in compliance with Good
COMPLETE QUESTIONS AND SOLUTIONS
GRADED A+
⩥ Inspection. Answer: The 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)
⩥ Interim Clinical Trial/Study Report. Answer: A report of intermediate
results and their evaluation based on analyses performed during the
course of the trial. (ICH GCP E6 1.32)
⩥ Investigational Product. Answer: A 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's Brochure. Answer: A compilation of the clinical and
nonclinical data on the investigational products which is relevant to the
, study of the investigational products in human subjects. (ICH GCP E6
1.36)
⩥ Legally Acceptable Representative. Answer: An individual or
juridicial or other body authorized under applicable law to consent, on
behalf of a prospective subject, to the subjects participation in the
clinical trial. (ICH GCP E6 1.37)
⩥ Monitoring Report. Answer: A written report from the monitor or
sponsor after each site visit and/or other trial-related communication
according to the sponsor's SOPs. (ICH GCP E6 1.39)
⩥ Multicentre Trial. Answer: A clinical trial conducted according to a
single protocol but at more than one site, and therefore, carried out by
more than one investigator. (ICH GCP E6 1.40)
⩥ Nonclinical Study. Answer: Biomedical studies not performed on
human subjects. (ICH GCP E6 1.41)
⩥ Protocol Amendment. Answer: A written description of changes to or
formal clarification of a protocol. (ICH GCP E6 1.45)
⩥ Quality Assurance (QA). Answer: All those planned and systematic
actions that are established to ensure that the trial is performed and the
data are generated, documented, and reported in compliance with Good
