Source Documentation and Data Flashcards

How long must investigators typically retain essential documents, including source documents, after a clinical trial is completed under FDA regulations?

Answer: 2 years after the date of marketing approval or discontinuation of the IND

Under 21 CFR 312.62, investigators must retain records for two years after marketing approval or, if approval is not sought, two years after discontinuation of the IND.

A subject verbally reports a new symptom to site staff who document it in their notes but forget to enter it in the EDC for three weeks. Which ALCOA principle is most directly violated?

Answer: Contemporaneous

The three-week delay between observation and EDC entry violates the contemporaneous requirement that data be recorded at the time of the event.

During a site audit, the investigator is asked to produce the original signed informed consent forms. These documents are most accurately categorized as:

Answer: Essential documents and also source documents for consent data

Signed informed consent forms are both essential documents required by GCP and source documents capturing the date, time, and fact of subject consent.

When a subject's diary is used to collect patient-reported outcomes, the diary entries are considered:

Answer: Source data because they are the original record of subject-reported observations

Subject diaries constitute original records of patient-reported information and therefore qualify as source data under GCP.

What is the key difference between a protocol deviation that must be documented in source records versus one that must also be reported to the IRB?

Answer: Deviations that affect subject rights, safety, or data integrity, or that are persistent, generally require IRB reporting in addition to source documentation

While all deviations are documented in source records, those impacting subject safety, rights, welfare, or data integrity typically require prompt IRB notification per GCP and local regulations.

A CRC makes a data entry error in the EDC and asks the IT administrator to delete the erroneous record from the audit trail to 'clean up' the data. This action is:

Answer: A violation of data integrity requirements; audit trails must not be altered or deleted

Deleting or altering audit trail entries violates 21 CFR Part 11 and GCP data integrity requirements; errors must be corrected through the proper query and amendment process.

Which scenario best illustrates the 'Complete' attribute of the ALCOA+ framework?

Answer: Documenting all required data fields for every study visit, including 'not done' or 'not applicable' entries where relevant

Completeness requires that all data fields are addressed, including explicit documentation of missing or inapplicable data so the record reflects the full clinical picture.