Mixed Deck — All CCRA Topics Flashcards

A sponsor-CRA learns that an investigator has not reported a serious adverse event (SAE) to the IRB within the required timeframe. What must the CRA do?

Answer: Document the finding, notify the investigator of the obligation, and escalate to sponsor management per the monitoring plan

The CRA must document the deviation, remind the investigator of their reporting obligation, and escalate to sponsor management as specified in the monitoring plan.

Dosage and safety (Find out how the medicine affects human metabolism and pharmacology).

Answer: Primary purpose of a phase 1 study?

The primary purpose of a Phase 1 clinical study is to evaluate the safety of a new drug, determine a safe dosage range, and identify potential side effects. These studies also investigate the drug's pharmacokinetics (how the body processes the drug) and pharmacodynamics (how the drug affects the body) in humans. This initial phase helps establish the drug's basic profile in humans.

What does the term 'source document verification (SDV)' refer to in clinical monitoring?

Answer: Comparing CRF data to original source documents to confirm accuracy

SDV is the process of comparing data recorded in the CRF against original source documents to ensure data accuracy and integrity.

A subject's source document shows a glucose value of 450 mg/dL, but the CRF records 45 mg/dL. How should this discrepancy be handled?

Answer: Issue a data query to the site to correct the CRF entry with a documented explanation

Transcription errors between source documents and CRFs must be resolved through a formal data query so the correction is auditable.

Which organization administers the CCRA certification examination in the United States?

Answer: The Association of Clinical Research Professionals (ACRP)

ACRP (Association of Clinical Research Professionals) administers the CCRA certification exam and sets the competency standards for clinical research associates.

When investigational product is returned from a site for destruction, the CRA must confirm:

Answer: All returned IP is properly labeled, logged, and accompanied by documentation confirming quantities and condition

Returned IP must be documented with quantities matching records, properly labeled, and accompanied by return authorization documentation; this ensures full accountability and proper destruction.

The initial recording of data for a clinical study is called __________ and comprises notes from observations, lab results, and other relevant documents.

Answer: Source Document

A source document is the original record of clinical findings, observations, or other activities in a clinical trial. It includes all information, original records, and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Examples include hospital records, clinic charts, lab results, and investigator's notes.

What is the PRIMARY purpose of a Site Qualification Visit (SQV) conducted by a CRA?

Answer: To assess the site's capability and resources to conduct the clinical trial

The SQV evaluates whether the site has adequate facilities, staff expertise, patient population, and regulatory infrastructure to successfully conduct the trial.

In a double-blind, randomized clinical trial, who is permitted to access the randomization codes in an emergency?

Answer: The treating physician when unblinding is medically necessary for a subject's safety

Emergency unblinding is permitted when the treating physician determines that knowledge of treatment assignment is necessary to provide appropriate medical care to the subject.

What is the primary regulatory framework governing the protection of human research subjects in federally funded research in the United States?

Answer: The Common Rule (45 CFR Part 46)

The Common Rule (45 CFR Part 46) is the primary federal regulation for protecting human subjects in research conducted or supported by federal agencies.

A study subject becomes pregnant during a clinical trial of a teratogenic investigational compound. After being taken off study drug, what additional obligation typically applies?

Answer: The pregnancy must be reported as an SAE and followed to outcome

Pregnancies in trials of potentially teratogenic drugs are typically reportable SAEs, and pregnancy outcomes (including neonatal outcomes) must be tracked and reported.

Which document type serves as the definitive guide for CRAs on how to perform site visits for a specific trial?

Answer: Monitoring Plan

The Monitoring Plan specifies the monitoring strategy, methodology, responsibilities, and procedures to be followed during trial monitoring visits.

ICH E6(R2) defines 'essential documents' as those that individually and collectively permit evaluation of the conduct of a trial and:

Answer: The quality of the data produced

Essential documents allow evaluation of both the conduct of the trial and the quality of data generated, and are required to be maintained throughout and after the trial.

During IP reconciliation at a monitoring visit, the CRA discovers more units were dispensed than accounted for in subject dosing records. The FIRST action is to:

Answer: Investigate the discrepancy with site staff and document findings; notify the sponsor if unresolved

IP discrepancies must be investigated with site staff to identify the cause; if unexplained, the sponsor must be notified, and depending on severity, regulatory reporting or a for-cause audit may be required.

Under FDA 21 CFR Part 312, the sponsor must notify the FDA of an IND safety report (IND Safety Report) within how many calendar days for unexpected fatal or life-threatening SUSARs?

Answer: 7 calendar days

Fatal or life-threatening unexpected serious adverse reactions must be reported to the FDA within 7 calendar days of the sponsor's first knowledge.

A Monitoring Visit Report (MVR) must be completed and submitted to the sponsor within the timeframe specified in the monitoring plan primarily to:

Answer: Document visit findings and ensure timely follow-up on issues identified

The MVR documents all findings, actions taken, and required follow-up items to ensure issues are tracked to resolution and the sponsor maintains oversight of site compliance.

Centralized monitoring differs from on-site monitoring in that it:

Answer: Involves remote review of accumulating data to identify trends and signals

Centralized monitoring uses statistical analysis and remote data review to detect data anomalies, enrollment patterns, and compliance signals without requiring a site visit.

A CRA is reviewing the drug accountability log and notices that the quantity of investigational product dispensed does not reconcile with what subjects received. What should the CRA do?

Answer: Flag the discrepancy, discuss with the pharmacist or site coordinator, and document in the monitoring report

Drug accountability discrepancies must be investigated, discussed with site staff, and documented in the monitoring report to ensure chain of custody.

When a CRA finds that a site has enrolled a subject who did not meet all inclusion criteria, this is documented as:

Answer: A protocol deviation or violation

Enrolling a subject who fails to meet inclusion criteria is a protocol deviation (or violation if major), which must be documented, reported to the sponsor, and may require IRB notification.

The ALCOA+ principles add which additional attributes beyond ALCOA?

Answer: Complete, Consistent, Enduring, and Available

ALCOA+ expands the original five attributes with Complete (all data present), Consistent (coherent dates/sequences), Enduring (recorded on durable media), and Available (accessible for review and audit).