
Below are manuals and instruction materials applicable to managing clinical
trials at UCSF.
California State Regulations Regarding
Venipuncture
A summary of the regulations requiring and overseeing certification
of phlebotomists.
Clinical Research Forms
Guideline For 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.
UCSF Investigator's Guide to Regulatory Responsibilities
for Industry Sponsored FDA Regulated Clinical Trials
A compendium of the main regulations and regulatory guidance governing
investigator responsibilities in the conduct of industry sponsored FDA
regulated clinical trials.
UCSF 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.
SFGH Medical Center Research Subject
Registration and Billing Manual
UCSF Medical Center Research Subject
Registration and Billing Manual
UCSF School of Medicine Budget
Policy for Industry-Sponsored Clinical Trials
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.
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