Patient Assessment & Evaluation Flashcards

RECIST 1.1 criteria for tumor response assessment classify a ≥30% decrease in the sum of diameters of target lesions as:

Answer: Partial Response (PR)

RECIST 1.1 defines Partial Response (PR) as at least a 30% decrease in the sum of diameters of target lesions compared to baseline.

A subject misses a scheduled assessment window for a key efficacy endpoint. The study team obtains the assessment 5 days outside the protocol window. How should this be handled?

Answer: Document the deviation, collect the assessment, and report the protocol deviation per site procedures

Out-of-window assessments should still be collected for subject safety, documented as a protocol deviation, and reported according to site and sponsor procedures.

Patient-Reported Outcomes (PROs) in clinical trials must be collected in a standardized way to ensure data validity. Which practice is MOST important?

Answer: Allowing subjects to complete PRO instruments independently before clinical assessments and without coaching

PROs must be completed independently by subjects before clinical assessments to avoid bias; coaching or staff completion undermines the self-report validity that PROs are designed to capture.

At an end-of-study visit, a subject has an unresolved adverse event of Grade 2 peripheral neuropathy. What is the investigator's responsibility regarding this finding?

Answer: Continue to follow the subject and document resolution or outcome per protocol requirements

Investigators are responsible for following unresolved AEs until resolution, stabilization, or the subject is lost to follow-up, as defined by the protocol, even after study completion.

A biomarker-stratified clinical trial requires tumor tissue collection at baseline. A subject's archival biopsy is 4 years old. The protocol requires tissue collected 'within 3 years of enrollment.' What should the investigator do?

Answer: Obtain a new biopsy or consult the sponsor, as the archival sample does not meet protocol requirements

The archival tissue falls outside the protocol-specified 3-year window; the investigator must obtain fresh tissue or contact the sponsor for guidance before enrollment.

The Columbia Suicide Severity Rating Scale (C-SSRS) is used in clinical trials primarily to:

Answer: Systematically evaluate suicidal ideation and behavior as a safety endpoint

The C-SSRS is a validated tool required by the FDA to systematically assess suicidal ideation and behavior as a safety measure in clinical trials, particularly those involving CNS-active agents.

During a monitoring visit, the clinical research associate (CRA) finds that vital signs were not collected at a mandatory protocol visit for three subjects. As the investigator, what is the appropriate response?

Answer: Acknowledge the deviation, implement corrective actions, and complete a CAPA to prevent recurrence

Missing mandatory assessments require acknowledgment as protocol deviations, documentation of corrective and preventive actions (CAPA), and implementation of process improvements to prevent recurrence.