ICH-GCP Compliance Flashcards
7 cards from real CRA practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 ICH-GCP Compliance flashcards as text
According to ICH E6(R2), which of the following is NOT an acceptable reason to waive written informed consent?
Answer: The subject verbally agrees but states they are 'too busy' to sign the form
A subject's inconvenience or preference not to sign is not an acceptable basis for waiving written informed consent under ICH-GCP; waivers require IRB/IEC approval or legal authorization.
Under ICH-GCP, what is the minimum content required in a clinical trial protocol?
Answer: General information, rationale, objectives, design, subject selection, procedures, statistics, ethics, and data handling
ICH E6(R2) Section 6 specifies that a protocol must include general information, background, objectives, design, selection criteria, procedures, statistical considerations, and ethical/regulatory aspects.
What is meant by 'source data' as defined in ICH-GCP?
Answer: All information in original records and certified copies used to reconstruct and evaluate the trial
ICH E6(R2) defines source data as all information in original records and certified copies of original records of clinical findings, observations, or other activities used to reconstruct and evaluate the trial.
A CRA discovers during a monitoring visit that a subject was enrolled without meeting all eligibility criteria. What should the CRA do first?
Answer: Document the finding and discuss it with the investigator to determine appropriate action and reporting obligations
The CRA should document the protocol deviation and discuss it with the investigator to assess subject safety and determine reporting requirements per the protocol and GCP.
Under ICH E6(R2), how long before a trial begins should the investigator obtain IEC/IRB approval?
Answer: Written approval must be obtained prior to initiating the trial
ICH E6(R2) Section 4.4 requires that the investigator obtain written IEC/IRB approval prior to initiating the clinical trial.
In ICH-GCP, what is the purpose of a 'Certificate of Analysis' for an investigational product?
Answer: To document the identity, strength, purity, and quality of the investigational product
A Certificate of Analysis documents the quality attributes (identity, strength, purity) of the investigational product as tested by the manufacturer or an approved laboratory.
Which ICH-GCP requirement addresses the need for an audit trail in electronic data systems used in clinical trials?
Answer: ICH E6(R2) Section 5.5.3 — computerized systems must maintain an audit trail of data changes
ICH E6(R2) Section 5.5.3 requires that computerized systems used in clinical trials maintain a complete audit trail of all data entries, changes, and deletions.