CCRC flashcards
CCRC · 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.
- Form FDA 1572
- Statement of investigator for IND studies listing investigator, subinvestigators, facility, and IRB; must be updated before newly added staff perform study tasks.
- Site initiation visit purpose
- Sponsor meeting before activation that trains site staff on protocol, source documentation, IP handling, and safety reporting, and finalizes the delegation log.
- Essential documents
- Records demonstrating trial conduct and data quality before, during, and after the study; kept in the investigator site file and available for monitoring and inspection.
- Feasibility assessment
- Evaluation of whether a site can meet protocol demands, considering eligible patient volume, competing trials, staff qualifications, equipment, and pharmacy capacity.
- Informed consent timing
- Consent must be obtained before any study-specific procedure, including screening tests performed solely to determine eligibility for the trial.
- Legally authorized representative
- Individual permitted by law to consent on behalf of a participant unable to do so, such as a parent for a minor or a court-appointed guardian.
- Re-consent trigger
- New risk information or a protocol change that may affect a participant's willingness to continue requires IRB review and updated consent from enrolled participants.
- Assent versus consent
- Assent is a minor's affirmative agreement documented alongside LAR permission; consent is the legally effective authorization required for enrollment.
- ALCOA principles
- Source data must be attributable, legible, contemporaneous, original, accurate, and complete; corrections use a single line, initials, date, and reason.
- Delegation of duties log
- Record listing each study task and the qualified, trained staff member authorized to perform it; tasks cannot be delegated to unlisted personnel.
- Protocol deviation
- Any departure from the IRB-approved protocol; documented, assessed for participant safety and data integrity impact, and reported to the sponsor per timeline.
- Eligibility verification
- Confirmation that every inclusion and exclusion criterion is met using source documents dated before the first dose or study procedure.
- Serious adverse event criteria
- Death, life-threatening event, hospitalization or prolongation, persistent disability, congenital anomaly, or important medical event requiring intervention to prevent harm.
- Severity versus seriousness
- Severity grades intensity (mild, moderate, severe); seriousness describes a medical outcome. A severe headache is not automatically a serious adverse event.
- SUSAR reporting
- Suspected unexpected serious adverse reaction; requires expedited notification to the sponsor, commonly within 24 hours of site awareness, with follow-up reports.
- Expectedness assessment
- Judging whether an adverse event is listed in the investigator brochure or labeling at the observed specificity and severity; unlisted events are unexpected.
- Causality assessment factors
- Relationship to study product considers temporal association, biologic plausibility, dechallenge or rechallenge response, and alternative explanations for the event.
- Source-to-CRF reconciliation
- Comparison confirming each reported data point matches the source record, catching transcription errors and missing assessments before monitoring visits.
- Data query resolution
- Response to a sponsor query with corrected data and documented rationale; original entries remain visible in the audit trail and are never deleted.
- 21 CFR Part 11
- Regulation setting requirements for electronic records and signatures, including validated systems, audit trails, access controls, and signature attribution.
- Database lock
- Point at which the study database is frozen for analysis, requiring all queries resolved and outstanding data issues documented and closed.
- Monitoring visit preparation
- Assembling source documents, CRFs, regulatory binder, IP records, and an open-issues list so the monitor can verify compliance and data accuracy.
- CAPA plan
- Corrective and preventive action written in response to audit or inspection findings, including root cause, remediation steps, owners, due dates, and effectiveness checks.
- Inspection notification
- Upon regulatory inspector contact, the coordinator verifies credentials, notifies the sponsor immediately, and does not alter or destroy records.
- IP accountability records
- Documentation of receipt, dispensing, return, and destruction including date, quantity, lot number, participant ID, and dispenser for each transaction.
- Temperature excursion handling
- Documented deviation from required storage range; product is quarantined, sponsor notified, and disposition determined before any further dispensing.
- Specimen chain of custody
- Documented record of collection time, processing, labeling, storage temperature, and shipment receipt confirming specimen integrity from site to laboratory.
- Emergency unblinding
- Breaking the treatment code when needed for participant safety, following protocol procedures and documenting the reason and notification to the sponsor.
- ICH E6 GCP
- International standard for designing, conducting, recording, and reporting trials that involve human subjects, protecting rights and ensuring data credibility.
- 21 CFR Part 50
- US regulation governing informed consent requirements for human subjects research, including required elements and documentation of consent.
- IRB continuing review
- Periodic re-approval of a study at least annually or at the IRB-set interval; lapsed approval halts enrollment and new study procedures.
- Protocol amendment implementation
- Changes require IRB approval before use, except when needed to eliminate an apparent immediate hazard to participants, which is reported afterward.