ICH Good Clinical Practice Flashcards
7 cards from real SOCRA practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 ICH Good Clinical Practice flashcards as text
In the context of ICH GCP, what is the purpose of the Trial Master File (TMF)?
Answer: To contain essential documents that allow evaluation of trial conduct and data quality
The TMF holds essential documents that individually and collectively permit evaluation of the conduct of the trial and the quality of the data produced.
Under ICH E6, which of the following is considered an essential document maintained by BOTH the investigator and the sponsor?
Answer: Signed protocol and all amendments
ICH E6 Appendix lists the signed protocol and amendments as essential documents that must be maintained by both the investigator and the sponsor.
An FDA inspector arrives at an investigational site. Under ICH GCP and FDA regulations, the investigator should:
Answer: Permit inspection of all records related to the clinical investigation
GCP and FDA regulations require investigators to permit FDA inspection of all trial-related records, and investigators must facilitate regulatory agency access.
What is the key distinction between a GCP audit and a GCP inspection?
Answer: Audits are conducted by the sponsor's QA function; inspections are conducted by regulatory authorities
Under ICH E6, a GCP audit is an independent quality assurance function performed by the sponsor, whereas an inspection is a formal examination by a regulatory authority.
According to ICH GCP, source documents are best described as:
Answer: Original records and certified copies of original information used to reconstruct the trial
Source documents include original records—medical records, lab reports, diaries—and certified copies that allow reconstruction of each subject's trial experience.
A CRA discovers discrepancies between the source data and the CRF during a monitoring visit. Under ICH GCP, the monitor should:
Answer: Document the discrepancies in the monitoring report and request corrections through the investigator
ICH E6 requires monitors to document data discrepancies in visit reports and ensure that only authorized site personnel make and initial corrections to source documents and CRFs.
Under ICH GCP, what does the concept of 'direct access' grant to monitors, auditors, and inspectors?
Answer: Permission to examine, analyze, verify, and reproduce any records related to the trial
Direct access under ICH E6 means that authorized oversight personnel may examine, analyze, verify, and reproduce any records pertinent to the trial at the trial site.