CPI Clinical Documentation & Records 3

Question 1

Which document formally defines the data to be collected, the CRF structure, and the validation rules for a clinical trial?

Accepted Answer

The data management plan

Answer

The data management plan (DMP) specifies how data will be collected, managed, and validated throughout the trial, including CRF design and edit checks.

Question 2

When must a serious adverse event (SAE) be documented in the source record?

Accepted Answer

As soon as it is identified or reported by the subject

Answer

GCP requires contemporaneous documentation; SAEs must be recorded in the source record as soon as they are identified or reported.

Question 3

A monitor reviewing source documents notices that several lab values are recorded in the CRF but cannot be found in the hospital chart. This situation is called:

Accepted Answer

A source data verification failure or data inconsistency

Answer

When CRF data cannot be traced to a source document, this represents a source data verification (SDV) failure indicating a data integrity concern.

Question 4

In electronic records, 21 CFR Part 11 requires that electronic signatures be:

Accepted Answer

Linked to their respective electronic records and include the printed name, date/time, and meaning of signature

Answer

21 CFR Part 11 mandates that electronic signatures include the printed name of the signer, date/time of signing, and the meaning of the signature (e.g., approval, review).

Question 5

Protocol amendments that change study procedures must be reflected in the source documents by:

Accepted Answer

Documenting the amendment approval date and updating procedures in subsequent visit notes

Answer

Once an amendment is approved, subsequent documentation should reflect the updated procedures, noting the amendment effective date in the records.

(CPI) Certified Physician Investigator Practice Test

(CPI) Certified Physician Investigator Practice Test

CPI Clinical Documentation & Records 3