BMAT Regulatory Frameworks & Compliance 5 — Questions and Answers
Question 1: A clinical investigator fails to obtain informed consent from a research participant before enrolling them in a study. Under GCP, this constitutes:
- A protocol deviation requiring documentation but no further action
- A serious breach that must be reported to the IRB/IEC and sponsor (Correct answer)
- An acceptable exception if the participant later provides verbal consent
- Only a concern if the participant subsequently experiences an adverse event
Correct answer: A serious breach that must be reported to the IRB/IEC and sponsor
Failure to obtain informed consent is a serious GCP violation that must be promptly reported to the IRB/IEC and sponsor, as it directly violates participant rights and regulatory requirements.
Question 2: Under FDA's cGMP (Current Good Manufacturing Practice) regulations, what is the primary purpose of a batch record?
- To market the finished product to healthcare providers
- To document that a drug product was manufactured and tested according to established procedures (Correct answer)
- To record adverse events reported after the drug reaches the market
- To track the financial costs associated with drug production
Correct answer: To document that a drug product was manufactured and tested according to established procedures
A batch record (or batch production record) documents all steps in manufacturing a specific lot of drug product, providing traceability and evidence of compliance with approved procedures.
Question 3: The Sunshine Act (Open Payments Program) in the U.S. requires pharmaceutical and device manufacturers to publicly report which type of information?
- Sales volumes and pricing data for all marketed products
- Payments and transfers of value made to physicians and teaching hospitals (Correct answer)
- Internal R&D expenditures by therapeutic area
- Adverse event data from post-market surveillance
Correct answer: Payments and transfers of value made to physicians and teaching hospitals
The Physician Payments Sunshine Act requires manufacturers to report payments and other transfers of value (e.g., consulting fees, meals, research funding) made to covered recipients, promoting transparency in financial relationships.
Question 4: A research institution receives federal funding and must comply with the Common Rule. Which office is responsible for assuring the institution's compliance with human subjects regulations?
- The Food and Drug Administration (FDA)
- The Office for Human Research Protections (OHRP) (Correct answer)
- The National Institutes of Health (NIH) Office of Research Integrity
- The Centers for Medicare & Medicaid Services (CMS)
Correct answer: The Office for Human Research Protections (OHRP)
OHRP, within the Department of Health and Human Services, provides oversight and guidance on compliance with the federal regulations protecting human research subjects (45 CFR 46).
Question 5: Which of the following scenarios best illustrates a 'conflict of interest' in biomedical research that must be disclosed?
- A researcher collaborating with a colleague at a different university
- A principal investigator holding equity in a company whose product is the subject of their funded study (Correct answer)
- A research team using commercially available reagents purchased at market price
- A clinical trial using a placebo arm to compare against an active treatment
Correct answer: A principal investigator holding equity in a company whose product is the subject of their funded study
A PI holding financial equity in a company whose product they are studying creates a direct financial conflict of interest that must be disclosed to the institution and funding agency.
Question 6: The EU Medical Device Regulation (MDR 2017/745) requires that Class III medical devices undergo which type of conformity assessment?
- Self-certification by the manufacturer with no third-party review
- Assessment by a Notified Body, including clinical evaluation and quality system audit (Correct answer)
- Review exclusively by the European Medicines Agency (EMA)
- Approval by each individual EU member state's health authority
Correct answer: Assessment by a Notified Body, including clinical evaluation and quality system audit
Under EU MDR, Class III (highest-risk) devices must undergo conformity assessment by an accredited Notified Body, which reviews clinical evidence and the manufacturer's quality management system before CE marking is granted.
Question 7: A pharmaceutical company sponsors a study and also employs the statistician who will analyze the blinded trial data. Which GCP principle is most directly at risk?
- Minimization of participant burden
- Independence and integrity of data analysis (Correct answer)
- Equitable subject selection
- Timely regulatory submission
Correct answer: Independence and integrity of data analysis
Having a sponsor-employed statistician analyze the data creates a potential bias risk, undermining the independence and integrity of the analysis — GCP and ICH E9 guidelines emphasize pre-specified, unbiased statistical analysis.
BMAT Regulatory Frameworks & Compliance 5
A clinical investigator fails to obtain informed consent from a research participant before enrolling them in a study.
Under GCP, this constitutes: