Research Manuals and Guidelines
Below are manuals and instruction materials applicable to managing clinical
trials at UCSF.
School of Medicine Budget Policy for Industry-Sponsored Clinical Trials
Look under the heading for "Faculty and Staff" and "F&A Rates" to find financial information. This policy, which complements and clarifies existing UC and campus policies
in this area, has been adopted by the School of Medicine and went into
effect August 23, 2001 and contains:
- Budget devleopment tools
- Pre-award process
- Finacial Mangement of the award
the Distribution and Filing of Informed Consent Forms - UCSF Medical Center
at Parnassus and Mt. Zion, and San Francisco General Medical Center
This link contains suggested guidance regarding the filing of informed consent forms in the central medical record for UCSF clinical trials conducted
at the Parnassus, Mt. Zion, and SFGH campuses.
Guide to Regulatory Responsibilities for Industry Sponsored FDA Regulated
A compendium of the main regulations and regulatory guidance governing
investigator responsibilities in the conduct of industry sponsored FDA
regulated clinical trials.
Research Record Retention Requirements Summary
A summary of the UC policies, regulations and regulatory guidance governing
the retention of research records.
UCSF Research Subject Registration
and Billing Manuals
Instructions for the proper registration of UCSF research subjects and
billing to UCSF clinical research accounts. Separate manuals are available
for San Francisco General Hospital (SFGH) Medical Center and UCSF Medical
Center (Parnassus and Mt. Zion campuses). The forms contained in the manuals
are available to download below each respective manual.
Medical Center Research Subject Registration and Billing Manual
Medical Center Research Subject Registration and Billing Manual Downloads