11. Designing of clinical study documents (protocol, CRF, ICF, PIC with assignment)

Curriculum Unit: 2. Clinical development of drug

This study module covers "Designing of clinical study documents (protocol, CRF, ICF, PIC with assignment)", an integral component of the Year 5 Doctor of Pharmacy (Pharm.D) curriculum under Clinical Research (Clinical development of drug). Designed for clinical pharmacy scholars, the syllabus emphasizes mechanistic understanding, clinical relevance, and high-yield examination competencies.

Upon reviewing this syllabus topic, Pharm.D students are expected to demonstrate proficiency in:

• Understand the foundational etiology, classification, and clinical significance of Designing of clinical study documents (protocol, CRF, ICF, PIC with assignment).
• Analyze the underlying pathophysiology and disease manifestations relevant to Clinical development of drug.
• Evaluate evidence-based pharmacotherapeutic management, therapeutic drug choices, and dosage individualization.
• Identify critical patient monitoring parameters, adverse drug reactions (ADRs), and drug-drug interactions.

Standard literature and institutional sources for Clinical Research:

• [1]Pharmacy Council of India (PCI) Pharm.D Curriculum Syllabus Guidelines
• [2]Pharmacotherapy: A Pathophysiologic Approach (Joseph T. DiPiro et al.)
• [3]Koda-Kimble and Young's Applied Therapeutics: The Clinical Use of Drugs
• [4]Standard National and International Clinical Practice Guidelines (WHO, ACC/AHA, IDSA)