CCDM Regulatory Requirements 5

Question 1

What is the primary regulatory basis for requiring a Statistical Analysis Plan (SAP) to be finalized before database lock in a clinical trial?

Accepted Answer

To prevent post-hoc analysis decisions that could introduce bias into the trial results

Answer

Pre-specifying analyses in a finalized SAP before unblinding prevents data-driven changes to analysis methods that could bias results and undermine regulatory submission integrity.

Question 2

Which FDA regulation defines the requirements for investigator recordkeeping and record retention at clinical trial sites?

Accepted Answer

21 CFR 312.62

Answer

21 CFR 312.62 specifies that investigators must maintain adequate records of drug disposition and case histories and retain them for at least 2 years after the marketing application approval.

Question 3

Under CDISC standards adopted by the FDA for electronic submissions, which standard governs the format of clinical trial data tabulations?

Accepted Answer

SDTM (Study Data Tabulation Model)

Answer

SDTM defines a standard structure for organizing and formatting clinical trial data tabulations submitted to the FDA as part of regulatory submissions.

Question 4

When a clinical trial site loses its essential documents due to a natural disaster, what is the investigator's regulatory obligation?

Accepted Answer

Notify the sponsor and IRB immediately and take steps to reconstruct or replace lost records to the extent possible

Answer

Investigators must promptly notify sponsors and IRBs of lost essential documents and make reasonable efforts to reconstruct lost records, as regulators may still require them during inspections.

Question 5

According to the FDA's guidance on computerized systems in clinical investigations, what is required when making corrections to electronic clinical data?

Accepted Answer

The original entry must be preserved, the correction made with date, time, and identity of the person making the change, and a reason provided

Answer

FDA guidance requires that audit trails preserve original data, and corrections must include the who, when, and why of each change without obscuring the original entry.

(CCDM) Certified Clinical Data Manager Practice Test

(CCDM) Certified Clinical Data Manager Practice Test

CCDM Regulatory Requirements 5