Chapter 1
Drug Development Process
NotesPDF · 496 KB
Study Clinical Research
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Chapter 2
Clinical Development of Drug
NotesPDF · 522 KB
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Clinical Research
Pharm.D · Year 5 · page 2 · 136 KB
PYQ & Important Questions
Prepare for Clinical Research.
Previous Year Questions
PYQs for this subject will be added later.
Important Questions
Original subject-specific practice questions for revision.
- Compare clinical-trial phases and the purposes of regulatory submissions.
- Explain good clinical practice and the responsibilities of sponsors, investigators and ethics committees.
- Discuss the information required for valid informed consent.
- Describe the purposes of a protocol, investigator brochure and case-report form.
- Explain how data management, monitoring and safety reporting support a reliable clinical trial.
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