NIH PRINCIPLES AND PRACTICES OF CLINICAL
RESEARCH IPPCR COMPREHENSIVE EXAM
2026 QUESTIONS WITH SOLUTIONS GRADED
A+
◉ Quality Assurance (QA). Answer: • Inspection system checking inputs
& outputs
• Inputs
- People (Investigator, study staff, & research
participants)
- Study design & design of CRFs & source docs
• Outputs
- Data
◉ QA of Study Personnel. Answer: • Education, credentials, training,
and experience
- Background in clinical area
- Operational, regulatory, ethical training in conduct of
clinical trials
- Certifications
• Association of Clinical Research Professionals (ACRP)
- 2 years of experience & passing exam
,• Study‐specific training
- Investigator meeting
- Initiation visit
◉ QA of Investigators. Answer: • Clinical expertise & research
experience
- Participate as a sub‐investigator
- ACRP certification for clinical research
investigators
- Investigator training programs
• Study‐specific training
- Investigator meeting
- Initiation Visit
◉ QA of Design. Answer: Well designed:
- Study
- Source documents
- CRFs
◉ QA of Data. Answer: Ensuring QA of inputs ultimately ensures QA
of outputs... the data
• Audits should occur to ensure integrity of data
,• Where does data come from?
• When should final QA inspection occur?
◉ Quality Improvement. Answer: 2 Basic Principles:
- Measurement of quality
- Design & redesign of production systems to
improve quality
◉ Measures of QI. Answer: Drug Accountability
• Regulatory Efficiency
• Informed Consent
• Eligibility
• Protocol Compliance
• Safety Reports
• Standard Operating Procedures (SOPs)
◉ FDA Mission. Answer: Promote & protect public health by helping
safe
& effective drugs reach market
• Monitor for continued safety after approved
• Enforce regulations regarding:
- Testing of drugs & medical devices in humans
, - Manufacturing process of drugs & devices
- Sanitation of foods
- Use of pesticides
- Veterinary medicine C
◉ FDA Regulations Enforcement. Answer: • Inspections & Audits
- Unannounced
• Enhances integrity of process
• Provides strong incentives for ensuring readiness at all
times
- Drawbacks:
• Variability with inspectors
• Inspectors do not specialize in one particular area
◉ FDA Regulations & Compliance. Answer: 3 general responsibilities
of investigators:
- Ensure study is conducted according to approved
protocol and signed investigator statement
- Protect rights, safety, and welfare of subjects
under their care
- Ensure control of drugs under investigation
RESEARCH IPPCR COMPREHENSIVE EXAM
2026 QUESTIONS WITH SOLUTIONS GRADED
A+
◉ Quality Assurance (QA). Answer: • Inspection system checking inputs
& outputs
• Inputs
- People (Investigator, study staff, & research
participants)
- Study design & design of CRFs & source docs
• Outputs
- Data
◉ QA of Study Personnel. Answer: • Education, credentials, training,
and experience
- Background in clinical area
- Operational, regulatory, ethical training in conduct of
clinical trials
- Certifications
• Association of Clinical Research Professionals (ACRP)
- 2 years of experience & passing exam
,• Study‐specific training
- Investigator meeting
- Initiation visit
◉ QA of Investigators. Answer: • Clinical expertise & research
experience
- Participate as a sub‐investigator
- ACRP certification for clinical research
investigators
- Investigator training programs
• Study‐specific training
- Investigator meeting
- Initiation Visit
◉ QA of Design. Answer: Well designed:
- Study
- Source documents
- CRFs
◉ QA of Data. Answer: Ensuring QA of inputs ultimately ensures QA
of outputs... the data
• Audits should occur to ensure integrity of data
,• Where does data come from?
• When should final QA inspection occur?
◉ Quality Improvement. Answer: 2 Basic Principles:
- Measurement of quality
- Design & redesign of production systems to
improve quality
◉ Measures of QI. Answer: Drug Accountability
• Regulatory Efficiency
• Informed Consent
• Eligibility
• Protocol Compliance
• Safety Reports
• Standard Operating Procedures (SOPs)
◉ FDA Mission. Answer: Promote & protect public health by helping
safe
& effective drugs reach market
• Monitor for continued safety after approved
• Enforce regulations regarding:
- Testing of drugs & medical devices in humans
, - Manufacturing process of drugs & devices
- Sanitation of foods
- Use of pesticides
- Veterinary medicine C
◉ FDA Regulations Enforcement. Answer: • Inspections & Audits
- Unannounced
• Enhances integrity of process
• Provides strong incentives for ensuring readiness at all
times
- Drawbacks:
• Variability with inspectors
• Inspectors do not specialize in one particular area
◉ FDA Regulations & Compliance. Answer: 3 general responsibilities
of investigators:
- Ensure study is conducted according to approved
protocol and signed investigator statement
- Protect rights, safety, and welfare of subjects
under their care
- Ensure control of drugs under investigation
