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Clinical Trials Resource Group

Clinical Trials Resource Group

CTSC Clinical Trials Resource Group maintains a number of helpful documents for your study management. Feel free to use them as is or modify for your specific purposes

Protocol

Study Protocol Template

Template for Simplified Study Summaries 

SPIRIT 2013 Statement: Defining Standard Protocol Items for Clinical Trials. A checklist to assist in drafting of high-quality protocols

Patient Management

Research Patient Contact Information Sheet

Concomitant Medication Log

Note to file

Progress Log 

Medical History

Adverse Event

Physical Exam

Maximum Allowable Total Blood Draw Volumes

NCI Toxicity Table

Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events

Vaccine Toxicity Grading Table 

 

Study Management Tools (courtesy of Neurosurgery)

Adverse Events Database (template in Access)

IRB Database (template in Access)

Patient Scheduler (template in Excel)

Screening and Enrollment Log (template in Excel)

Consent

Consent Process check list (helps you to document consent process)

Procedures for Assessing Capacity to consent (from UCD Alzheimer's Center)

Capacity Assessment Checklist for Research Informed Consent

Epic Certification for Part 11 Compliance

21 CFR Part II Electronic Documention (EPIC)

An example of EPIC EMR questionnaire for sponsors

UC Davis Epic Certification Letter for the FDA

 Disclosure Tracking Database

            Spreadsheet for monthly bulk uploads (including instructions)

            Disclosure Tracking Database

            EMR Quick Disclosure (CT Newsletter v.19, 2014)

IT Evaluation of software and hardware (both need to be filled out)

             Background Data

             Preliminary Checklist

 Radiology Procedure Request Form

             RAD Research Procedure Request