CCRA flashcards
CCRA · Build recall with a focused review session.
32 cards. Read the term and the definition here. The deck at the top of this page is optional.
- Source data verification
- Comparison of case report form entries against original medical records to confirm accuracy, completeness, and consistency; discrepancies become documented queries resolved with date and initials.
- Essential documents
- Records that individually and collectively permit evaluation of trial conduct and data quality; maintained in the sponsor trial master file and the investigator site file.
- Delegation log
- Site record listing each study task and the named, trained, qualified person authorized to perform it; confirms no task occurred before documented delegation and training.
- Investigational product accountability
- Running balance showing received minus dispensed minus returned minus destroyed equals on-hand stock; unexplained gaps are documented deviations requiring sponsor notification and reconciliation.
- Informed consent review
- Verification that the current IRB-approved version was signed and dated by subject and consenter, and that consent preceded any study-specific procedure.
- Monitoring visit report
- Formal post-visit record of findings, action items, responsible persons, and target dates, issued as a follow-up letter to the investigator; open items carry to the next visit.
- Adverse event reconciliation
- Cross-check of the AE log, CRF AE page, concomitant medications, and clinical narrative to confirm every treated or reported event is captured and consistently coded.
- Site close-out visit
- Final monitoring activity confirming queries closed, investigational product returned or destroyed with documentation, supplies reconciled, and investigator file complete before site release.
- Risk-based monitoring
- Monitoring frequency and intensity set according to enrollment volume, protocol complexity, endpoint risk, and site performance rather than a uniform schedule for all sites.
- Major protocol deviation
- Deviation affecting subject safety, rights, or data integrity, such as a missed exclusion criterion or unapproved concomitant medication; requires documentation, assessment, and corrective action.
- Screen failure rate
- Number of screen failures divided by total subjects screened; used to forecast enrollment timelines and assess whether eligibility criteria are too restrictive.
- Database lock
- Point at which all queries are resolved, coding is complete, and the database is frozen for analysis; subsequent changes require documented, controlled unblinding or audit-trailed correction.
- Randomization and blinding check
- Verification that allocation was obtained in sequence for each eligible subject, the assigned kit was dispensed, and any unblinding had documented emergency justification.
- Temperature excursion
- Deviation of investigational product storage outside the labeled range; documented with duration and extremes, with sponsor assessment required before affected product is dispensed.
- Visit window deviation
- Assessment or procedure performed outside the protocol-specified window; recorded with reason and impact on endpoint validity, and classified by severity.
- Serious adverse event reporting
- Site reports serious adverse events to the sponsor within 24 hours of awareness; sponsor then assesses causality and expectedness for expedited regulatory reporting.
- Good Clinical Practice pillars
- Protection of subject rights, safety, and well-being; generation of credible data; and documented quality systems covering sponsors, investigators, and monitors.
- IRB approval timing
- Approval must precede any study activity at a site; amendments and consent changes require approval before implementation except when needed to remove immediate hazard to subjects.
- Declaration of Helsinki
- International ethical principles for medical research involving human subjects; distinct from ICH E6, which addresses GCP conduct and documentation standards.
- Informed consent elements
- Required disclosures include purpose, procedures, risks, benefits, alternatives, confidentiality, compensation and injury provisions, voluntariness, and contacts for questions and research injury.
- Vulnerable populations
- Groups such as children, prisoners, pregnant women, and cognitively impaired persons requiring additional safeguards; children who can understand provide assent alongside parental permission.
- HIPAA research authorization
- US permission allowing use or disclosure of protected health information for research; an IRB or privacy board may waive authorization under specified criteria.
- GDPR lawful basis
- EU requirement that processing personal data rest on a lawful basis, with explicit consent or another specified ground required for research use of identifiable health data.
- Unanticipated problem reporting
- Reporting to the IRB of incidents that are unexpected, related to research, and suggest increased risk to subjects or others, including a risk assessment and corrective action.
- Follow-up letter
- Formal written record of a monitoring visit restating findings and assigning each action item to a named person with a due date, sent within the sponsor SOP timeframe.
- Escalation path
- Sequence from site coordinator to principal investigator to sponsor clinical lead to quality assurance; safety issues escalate immediately and bypass routine sequencing.
- Query writing rules
- Reference the field and visit, state the discrepancy factually, cite the source or protocol section, and avoid leading language that suggests the expected answer.
- Site training documentation
- Records capturing date, topic, trainer, attendee names, and signatures; amendment training must precede any subject undergoing amendment-related procedures.
- Pre-study qualification visit
- Assessment of investigator qualifications, facility adequacy, subject population access, and staff availability before site selection; negative assessments are documented with reasons.
- Issue log
- Tracking record for escalated unresolved findings listing owner, severity, due date, and closure evidence; reviewed at each subsequent monitoring visit until resolved.
- Principal investigator responsibility
- Investigator accountable for conduct of the trial at the site, including delegation oversight, informed consent integrity, safety reporting, and accuracy of all reported data.
- Site initiation visit
- Pre-enrollment visit confirming staff training, protocol understanding, investigational product handling procedures, and readiness of facilities before the first subject is enrolled.