RKS Resources

Information Sheet for Clinical Laboratory Testing

Get the Information Sheet for Clinical Laboratory Testing.

Presentations:

• NEW! Zarin, DA. Everything You Need to Know About Clinical Trials Registration and Results Reporting Requirements NIH webinar, October 2009. View as PowerPoint (6.2MB) or PDF (3.5MB)
• NEW! Tips for reporting basic results in ClinicalTrials.gov. Read article, July 2009.

First Regulatory Education Seminar

• Feigal - Regulations for Medical Device Development
• Grudzinskas - Drug Development Decision Points
• Kessler - The Federal Regulation of New Drugs
• Lee - Role of Academic Investigators in Drug Development
• Peck - Role of FDA in Guiding Drug Development

Second Regulatory Education Seminar

• Lee - Introduction
• Peck - Preclinical Data Package for IND Submission
• Savello - Chemistry, Manufacturing, and Controls of Drug Candidates for Dummies
• Sheevers - How Much Animal Data are Required to Move into Clinical Testing?
• Lee -Choosing a Dose for the First-Time-In-Human Study