CATO Associate Ethics & Good Clinical Practice (GCP) Flashcards
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Read the first 7 CATO Associate Ethics & Good Clinical Practice (GCP) flashcards as text
Under 21 CFR Part 50, a 'short form' written consent document may be used when:
Answer: The IRB determines that oral presentation of consent elements is appropriate and a witness is present
A short form may be used when the IRB approves oral presentation of consent elements to the participant, with a witness signing the document.
A monitor conducting a site visit cannot access source documents due to patient privacy restrictions at the site. GCP requires the monitor to:
Answer: Report the access issue to the sponsor and document the inability to verify data
If source document access is denied, the monitor must document the limitation and notify the sponsor, who must address the regulatory access rights per the trial agreement.
The principle of 'equipoise' in clinical research means that:
Answer: There is genuine uncertainty in the expert community about the comparative merits of the treatments being tested
Equipoise justifies a randomized controlled trial by confirming that there is honest, professional uncertainty about which treatment is superior.
An investigator site file (ISF) must contain all of the following EXCEPT:
Answer: Sponsor's internal financial audit reports
The ISF contains study conduct documents; internal sponsor financial audits are confidential sponsor records, not required in the ISF.
Which GCP guideline specifically governs statistical principles for clinical trials, complementing ICH E6?
Answer: ICH E9
ICH E9 provides statistical principles for clinical trials, including randomization, blinding, and analysis population definitions.
A research site experiences a fire that destroys original paper case report forms. GCP requires the investigator to:
Answer: Notify the sponsor, document the event, and implement data recovery from certified copies or source documents
Lost essential documents must be reported to the sponsor; recovery from certified copies or remaining source documents should be attempted, and the incident fully documented.
The ICH E6(R2) definition of 'essential documents' is best described as:
Answer: Documents that allow evaluation of the conduct of the trial and the quality of the data produced
Essential documents are those that individually and collectively allow evaluation of trial conduct and data quality, and are retained by both sponsor and investigator.