CRA (OPS) flashcards

32 cards. Read the term and the definition here. The deck at the top of this page is optional.

Nuremberg Code (1947)

Post-World War II code stating that voluntary consent of the human subject is absolutely essential, that subjects may withdraw, and that research risks must be justified by expected benefits.

Belmont Report Principles

1979 U.S. report identifying three ethical principles for human subjects research: respect for persons, beneficence, and justice, applied through informed consent, risk-benefit assessment, and fair subject selection.

IRB Membership Requirements

An IRB needs at least five members, at least one non-scientific member, at least one member independent of the institution, and diversity of sex; an unrepresented sex must be documented.

21 CFR Part 50

U.S. regulation governing protection of human subjects, including informed consent requirements and IRB review of research; Part 56 separately covers IRB organization and operations.

Form FDA 3455

Financial disclosure form used when an investigator or sub-investigator has a disclosable interest such as equity, consulting fees, or payments above the regulatory threshold.

Pre-Study Qualification Visit

Visit conducted before trial start to assess whether a site has adequate patient population, qualified staff, facilities, equipment, and GCP familiarity to conduct the protocol successfully.

Site Feasibility Assessment

Evaluation of a site's ability to recruit and retain subjects, covering population size, competing trials, staff experience, facilities, and predicted enrollment rate per month.

Form FDA 1572

Statement of Investigator signed by the PI, committing to conduct the study per the protocol and GCP and listing the investigator's qualifications and research facilities.

Delegation of Authority Log

Site document listing each staff member and the specific study tasks delegated to them; the PI must sign and date it before those tasks are performed.

Site Initiation Visit

Meeting held after IRB and regulatory approval but before subject screening, at which the monitor trains staff on protocol, GCP, IP handling, and safety reporting.

ALCOA+ Data Criteria

Data quality standard: Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, and Available; used to judge source and CRF data.

Source Data Verification

Comparison of CRF entries against original source documents to confirm that the reported data are accurate, complete, and supported by the medical record.

Risk-Based Monitoring

Monitoring approach directing effort to the most critical data and processes based on assessed risk; ICH E6(R2) allows reduced on-site verification when justified and documented.

Major Protocol Deviation

A deviation that may affect subject safety, rights, or data integrity; it must be documented, reported to the sponsor and IRB per policy, and followed by corrective action.

Serious Adverse Event

An adverse event causing death, being life-threatening, requiring hospitalization or prolongation, causing persistent disability or congenital anomaly, or requiring intervention to prevent a serious outcome.

SUSAR

Serious Unexpected Suspected Adverse Reaction: a serious event not listed in the reference safety information and for which a reasonable causal relationship to the investigational product is possible.

7-Day IND Safety Report

Expedited report to FDA for fatal or life-threatening unexpected suspected adverse reactions from a clinical trial, due within 7 calendar days of the sponsor's initial receipt of the information.

Severity Versus Seriousness

Severity describes intensity as mild, moderate, or severe; seriousness describes regulatory outcome criteria such as death or hospitalization. A severe event is not automatically serious.

IP Accountability Records

Logs documenting receipt, inventory, dispensing, return, and destruction of investigational product, enabling reconciliation of all quantities by lot and by subject.

Temperature Excursion Handling

Document the deviation, quarantine affected product, notify the sponsor, and await a stability assessment before dispensing; the excursion and final disposition must be recorded.

Emergency Unblinding

Protocol-defined procedure to reveal a subject's treatment assignment when required for medical management; it must be documented and the sponsor notified promptly.

Investigational Product Destruction

Disposal of unused or expired study drug at the site only after written sponsor authorization and in accordance with local regulations, with the destruction documented.

Data Query Resolution

Process in which the site answers a data clarification request with source-supported information, the response is reviewed, and the query is closed with an audit trail entry.

21 CFR Part 11

FDA regulation requiring electronic records and signatures to be trustworthy: validated systems, secure access, audit trails, and controls over record retention and signature attribution.

MedDRA Coding

Standardized medical dictionary used to code adverse events and medical history into preferred terms and system organ classes, enabling consistent analysis across sites and studies.

Database Lock

Formal point after all queries are resolved and data are cleaned, after which the database is frozen and any change requires documented authorization and an audit trail.

Close-Out Visit

Final monitoring visit after the last subject completes, confirming data cleanup, IP reconciliation, essential document collection, and archiving arrangements before site closure.

Two-Year Record Retention

Minimum retention period under ICH E6(R2): at least 2 years after the last marketing application approval or 2 years after formal discontinuation of the investigation.

Final Report to IRB

Summary submitted to the IRB or IEC at study completion describing conduct, enrollment, adverse events, and deviations; required by many institutions and by ICH GCP.

Trial Master File

Collection of essential documents held by the sponsor, with a corresponding site file, demonstrating that the trial was conducted according to GCP and applicable regulations.

Essential Documents

Records that individually and collectively permit evaluation of trial conduct and data quality; listed by phase, before, during, and after the trial, in ICH E6(R2) Section 8.

Investigator Site File

Repository at the site containing essential documents such as the protocol, investigator brochure, approvals, delegation log, training records, and investigational product accountability logs.