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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

Manual forms:
Account and Fund Request Form
Account and Fund Request Form
Investigational Drug Services Form
Procedure Rate Contact List
Research Patient Identification Card Request
Research Subject Registration and Admission
SFGH Protocol Application
SFGH Request for Index Code/Cost Center
Special Research Account Application Facility Use Fees for Clinical/Ancillary Services Form


UCSF Medical Center Research Subject Registration and Billing Manual


Manual forms:
Account and Fund Request Form
Clinical Research Study ZZ Medical Record/Visit Number Creation Request
Label Requisition Form - Clinical Trial Subjects
New Patient Registration for Clinical Trial
Patient Reservation Form, Part A
Patient Reservation Form, Part B
Procedure Rate Contact List
Speedchart Request Form


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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