Site Management Flashcards
6 cards from real SOCRA CCRP practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 6 Site Management flashcards as text
What is a 'site qualification visit' (SQV) and when does it occur?
Answer: A pre-study visit by the sponsor/CRO to assess whether a site meets the requirements to conduct the trial
An SQV is conducted before site selection to evaluate the investigator's qualifications, facilities, subject population, and capacity to conduct the specific study.
What is the difference between 'on-site monitoring' and 'remote monitoring' in clinical trials?
Answer: On-site monitoring involves the monitor physically visiting the site; remote monitoring uses electronic systems to review data without a site visit
On-site monitoring involves a physical visit to verify source documents and observe site operations, while remote monitoring reviews data electronically without visiting the site.
What is 'source document verification' (SDV) and why is it important?
Answer: The process of comparing CRF data to source documents to confirm accuracy and completeness of reported data
SDV involves comparing data recorded in the CRF against the original source documents to verify accuracy, completeness, and consistency of trial data.
What is a 'monitoring visit report' and who receives it?
Answer: A written record prepared by the monitor after each visit, sent to the sponsor, documenting findings and action items
The monitoring visit report documents all findings, observations, and required action items from the visit and is sent to the sponsor and trial master file.
What is a 'corrective and preventive action' (CAPA) plan in clinical trial site management?
Answer: A documented plan to address identified deficiencies and prevent their recurrence
A CAPA plan documents the root cause of identified deficiencies, corrective actions to fix current issues, and preventive measures to stop recurrence.
What must a site do if the Principal Investigator leaves during an ongoing clinical trial?
Answer: Notify the sponsor and IRB, arrange for a qualified replacement PI, and obtain necessary approvals before continuing
An investigator change requires notifying the sponsor and IRB, submitting updated regulatory documents for the replacement PI, and receiving approval before the new PI assumes responsibility.