CLE Good Clinical Practice & ICH Guidelines 3 — Questions and Answers
Question 1: The principle of data integrity in GCP-compliant lactation research requires that study records be:
- Stored only in electronic format approved by the FDA
- Attributable, legible, contemporaneous, original, and accurate (ALCOA) (Correct answer)
- Available exclusively to the principal investigator
- Destroyed after the study is published to protect privacy
Correct answer: Attributable, legible, contemporaneous, original, and accurate (ALCOA)
GCP data integrity standards require records to be Attributable, Legible, Contemporaneous, Original, and Accurate — the ALCOA principle.
Question 2: In a lactation study, if an entry error is discovered in the case report form (CRF), GCP requires the correction to be made by:
- Completely obscuring the original entry with correction fluid
- Drawing a single line through the error, initialing, dating, and writing the correct value (Correct answer)
- Deleting the electronic record and re-entering data without documentation
- Having the IRB co-sign the corrected entry
Correct answer: Drawing a single line through the error, initialing, dating, and writing the correct value
GCP mandates that CRF corrections preserve the original entry — a single strikethrough with initials, date, and correct value maintains the audit trail.
Question 3: According to ICH E6, the investigator's brochure (IB) in a lactation clinical study is best described as:
- The final regulatory submission package sent to the FDA
- A compilation of clinical and nonclinical data about the investigational product relevant to its study in humans (Correct answer)
- A summary of the informed consent process for participants
- The IRB's approval letter for the study protocol
Correct answer: A compilation of clinical and nonclinical data about the investigational product relevant to its study in humans
The Investigator's Brochure is a document containing all available clinical and nonclinical information about the investigational product to guide investigators.
Question 4: A sponsor monitoring a lactation study under GCP oversight is primarily responsible for:
- Enrolling participants and obtaining informed consent on behalf of the site
- Overseeing the conduct of the trial to ensure data integrity, subject safety, and protocol compliance (Correct answer)
- Drafting and submitting all IRB applications without investigator input
- Setting fee schedules for study participants
Correct answer: Overseeing the conduct of the trial to ensure data integrity, subject safety, and protocol compliance
Under GCP, the sponsor oversees the entire trial to ensure it is conducted, recorded, and reported in accordance with the protocol, GCP, and regulations.
Question 5: ICH E6 distinguishes between 'essential documents' and other study records. Essential documents are those that:
- Must be published in a peer-reviewed journal within two years
- Individually and collectively permit evaluation of the trial conduct and quality of data produced (Correct answer)
- Are required only for multi-center studies with more than 100 participants
- Are created solely by the IRB during its annual review
Correct answer: Individually and collectively permit evaluation of the trial conduct and quality of data produced
Essential documents are defined as those that individually and collectively allow evaluation of the conduct of a trial and the quality of the data generated.
Question 6: When a lactation study protocol is amended after IRB approval, the amendment must be submitted to and approved by the IRB before:
- The sponsor is notified of the change
- Implementation of the change, except for immediate action needed to eliminate hazard to subjects (Correct answer)
- The next scheduled monitoring visit
- Publication of the study results
Correct answer: Implementation of the change, except for immediate action needed to eliminate hazard to subjects
GCP requires prior IRB approval of protocol amendments before implementation, unless immediate action is required to protect subjects from harm.
Question 7: GCP requires that clinical trial records, including those from lactation studies, be retained for at minimum:
- One year after publication of the study
- Two years after the last marketing application is approved or the trial is discontinued
- As defined in the protocol and applicable regulatory requirements (often 15+ years) (Correct answer)
- Six months after the final monitoring visit
Correct answer: As defined in the protocol and applicable regulatory requirements (often 15+ years)
GCP and applicable regulations typically require retention of clinical trial records for at least 15 years, or as specified by regulatory authorities and the protocol.
CLE Good Clinical Practice & ICH Guidelines 3
The principle of data integrity in GCP-compliant lactation research requires that study records be: