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Clinical Research Resources
Policies, Manuals and Guidelines
Tools, Checklists and Templates
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Clinical Research Tools

Below is a collection of forms and tools collected to assist in the conduct of clinical trials.

UCSF Clinical Trial Agreement with Industry(word doc)
Bolierplate agreement from the Industry Contracts Division for industry sponsored clinical trials.

UCSF Industry Sponsored Clinical Trial Budget Checklist (word doc)
A checklist of items to include in budgets for for industry sponsored clinical trials at UCSF.

Clinical Trial Regulatory File Checklist (xls spreadsheet)
An example of a checklist for clinical trial regulatory file contents.

Data and Safety Monitoring Plan Templates
Templates to use to create data and safety monitoring plans for NIH clinical trials conducted at UCSF.

Drug Accountability Logs
Below are several versions of logs that can be used for tracking investigational drug dispensing and accountability.
Drug Accountability Form (word doc)
Generic Drug Accountability Form (xls spreadsheet)
NCI Drug Accountability Form (word doc)

Protocol Feasibility Checklist (word doc)
This is a checklist to assist with determining whether a protocol can be successfully conducted.

Protocol Violation Documentation Form (word doc)
This is an example of a form that can be used to document protocol violations and deviations.

Research Administrator Clinical Trial Financial Tracking Report Templates
These templates were created to assist UCSF Research Administrators and other financial managers of clinical trials to prospectively set up tracking spreadsheets for clinical staff to provide the necessary information for financial reconciliation of clinical trials. The accompanying manual describes the set up and ongoing use of these tracking tools.
Tracking Spreadsheet (xls spreadsheet)
Tracking Spreadsheet manual (word doc)

Safety Reporting Flowchart (ppt)
A flowchart representing the decision tree for determining the minimum required expedited reporting of adverse events to the FDA for IND studies.

Site FDA Audit Checklist (xls spreadsheet)
An example of a checklist for clinical study site preparation for an FDA audit.

Study Budget Template (xls spreadsheet)
A template that can be used to create industry sponsored clinical trial budgets.

Study Management Checklist (word doc)
An example of a checklist of tasks required for the management of a clinical study.

Study Medication Calendar (pdf)
A calendar to assist study participants document investigational oral medication compliance.

Study Personnel Salary Worksheet (xls spreadsheet)
A worksheet to assist with determining personnel costs for a clinical study.

Study Subject Screening Tracking Form (xls spreadsheet)
An example of a form that can be used to track study subject screening and enrollment for a clinical study.

Subject Budget Template (xls spreadsheet)
A template that can be used to create a per subject budget for an industry sponsored clinical trial.

UCSF Non-Federal Clinical Study Internal Budget Template (xls spreadsheet)
This is a template that can be used to create an internal budget for UCSF Contracts and Grants packages that has been adapted for industry sponsored clinical trials.

Clinical Research Tools
Below is a collection of forms and tools collected to assist in the conduct of clinical trials. Clinical Research Tools, Checklists and Templates located at http://www.research.ucsf.edu/chr/QipTools.asp

Updated: May 17, 2007
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