- 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)
- 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
Biospecimens and Tissues
- UCSF Biospecimen Guide (pdf 1MB)
- Tissue Specimen Guide (pdf 84KB)
- BioShare — the Immune Tolerance Network's (ITN) Biomarker Sample Sharing Program
Online Resources to Support Randomized Controlled Trials (RCTs)
Note: The resources and comments below were provided by UCSF faculty. If you have feedback regarding these resources, or other suggestions to add, please let us know. Learn more about how these resources were identified.
- http://www.randomizer.at — For smaller studies; startup cost is $600 for first 50 enrollees and then $5/ additional enrollee.
- http://www.randomize.net — For large studies; flat fee of $2500 independent of enrollment size.
- Consultation Services Biostatistical Consulting Unit also provides help with randomization.
New! Table 1 SAS Macro available for download (UCSF access only). The macro generates a summary table that is useful for a simple analysis/first look at a data set, and a final demographic descriptive table that may be used in the typical Table 1 of a clinical paper.