CCDM Regulatory Requirements 3 — Questions and Answers
Question 1: According to ICH E6 R2, what must be included in the clinical trial agreement between a sponsor and a Contract Research Organization (CRO)?
- A written specification of all trial-related duties and functions transferred to the CRO (Correct answer)
- A list of all IRB members reviewing the protocol
- Copies of all investigators' CVs and medical licenses
- The sponsor's standard operating procedures for data entry
Correct answer: A written specification of all trial-related duties and functions transferred to the CRO
ICH E6 R2 requires that agreements between sponsors and CROs include a written specification of all duties and functions being transferred.
Question 2: Under 21 CFR Part 312, what is an Investigational New Drug (IND) application primarily designed to allow?
- A sponsor to ship an investigational drug across state lines for clinical testing (Correct answer)
- A sponsor to sell an unapproved drug to patients in clinical trials
- An investigator to prescribe an approved drug for an unapproved indication
- A manufacturer to begin commercial production of a new drug compound
Correct answer: A sponsor to ship an investigational drug across state lines for clinical testing
An IND allows a sponsor to legally transport and administer an investigational drug in interstate commerce for clinical trial purposes before FDA approval.
Question 3: Which of the following scenarios would constitute a protocol deviation rather than a protocol violation?
- A scheduled visit occurring one day late due to a holiday (Correct answer)
- Enrolling a subject who does not meet inclusion criteria
- Failing to obtain informed consent before study procedures
- Administering the incorrect dose to a subject
Correct answer: A scheduled visit occurring one day late due to a holiday
Minor, unintentional, non-significant departures from the protocol such as a visit one day late are typically classified as deviations rather than violations.
Question 4: What does the Declaration of Helsinki primarily establish for clinical research?
- Ethical principles for medical research involving human subjects (Correct answer)
- Data retention timelines for clinical trial records
- Statistical requirements for clinical trial design
- Regulatory submission standards for new drug applications
Correct answer: Ethical principles for medical research involving human subjects
The Declaration of Helsinki establishes the foundational ethical principles guiding medical research involving human participants, emphasizing participant welfare above scientific interests.
Question 5: In clinical data management, what is the primary regulatory purpose of maintaining an audit trail in an EDC system?
- To document all changes to data fields with who made them, when, and why (Correct answer)
- To track server uptime and system performance metrics
- To record the number of queries issued per data entry operator
- To log which users accessed the database without making changes
Correct answer: To document all changes to data fields with who made them, when, and why
Audit trails ensure data integrity by recording all changes to clinical data, including the original value, new value, user identity, timestamp, and reason for change.
Question 6: Which FDA guidance document describes the agency's current thinking on risk-based monitoring for clinical investigations?
- FDA Guidance on Risk-Based Monitoring (2013) (Correct answer)
- ICH E6 R2 addendum
- 21 CFR Part 312 Subpart D
- FDA Guidance on Electronic Source Records (2013)
Correct answer: FDA Guidance on Risk-Based Monitoring (2013)
The FDA's 2013 guidance on oversight of clinical investigations introduced a risk-based approach to monitoring as an alternative to traditional 100% source data verification.
Question 7: Under GDPR, which legal basis is most commonly used for processing clinical trial participant data in the EU?
- Public interest in the area of public health (Correct answer)
- Legitimate interests of the sponsor
- Consent alone without any additional legal basis
- Performance of a contract with the participant
Correct answer: Public interest in the area of public health
GDPR Article 9(2)(i) allows processing of special category health data for public interest reasons in the area of public health, commonly applied to clinical research.
CCDM Regulatory Requirements 3
According to ICH E6 R2, what must be included in the clinical trial agreement between a sponsor and a Contract Research Organization (CRO)?