Regulatory Requirements Flashcards
7 cards from real CCDM practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Regulatory Requirements flashcards as text
What is the primary regulatory basis for requiring a Statistical Analysis Plan (SAP) to be finalized before database lock in a clinical trial?
Answer: To prevent post-hoc analysis decisions that could introduce bias into the trial results
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.
Which FDA regulation defines the requirements for investigator recordkeeping and record retention at clinical trial sites?
Answer: 21 CFR 312.62
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.
Under CDISC standards adopted by the FDA for electronic submissions, which standard governs the format of clinical trial data tabulations?
Answer: SDTM (Study Data Tabulation Model)
SDTM defines a standard structure for organizing and formatting clinical trial data tabulations submitted to the FDA as part of regulatory submissions.
When a clinical trial site loses its essential documents due to a natural disaster, what is the investigator's regulatory obligation?
Answer: Notify the sponsor and IRB immediately and take steps to reconstruct or replace lost records to the extent possible
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.
According to the FDA's guidance on computerized systems in clinical investigations, what is required when making corrections to electronic clinical data?
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
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.
What is the regulatory significance of 'blinding' or 'masking' in randomized controlled trials from a data management perspective?
Answer: It prevents knowledge of treatment assignment from influencing data collection, entry, or analysis, reducing bias
Maintaining treatment blinding during data collection and management prevents conscious or unconscious bias in how data is recorded, queried, or interpreted before unblinding.
Which regulatory requirement mandates that all clinical trial participants must be registered in a public database before enrollment begins for trials of FDA-regulated products?
Answer: Section 801 of the FDA Amendments Act (FDAAA 801), implemented through ClinicalTrials.gov
FDAAA 801 requires registration of applicable clinical trials of FDA-regulated products on ClinicalTrials.gov before enrollment begins, with results reporting requirements after completion.