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 for a drug study (Word)

Study Protocol for a Device study - courtesy of University of Pennsylvania (Word)

Template for Simplified Study Summaries (PDF) 

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

Patient Management

Research Patient Contact Information Sheet (Word)

Concomitant Medication Log (Word)

Note to file (Word)

Progress Log (Word)

Medical History (Word)

Adverse Event (Word)

Physical Exam (Word)

Maximum Allowable Total Blood Draw Volumes (Word) 

NCI Toxicity Table (PDF)

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

Vaccine Toxicity Grading Table (PDF)

 

Study Management Tools (courtesy of Neurosurgery)

Adverse Events Database (template in Access)

 Patient Scheduler (template in Excel)

Screening and Enrollment Log (template in Excel)

Recruitment Tools (courtesy of Beth Harper, Clinical Performance Partners)

      Sample Recruitment Resource Plan (Word)

      Sample Recruitment Funnel Calculations (Excel)

      Recruitment Action Plan and Progress Report (Word)

Pathology (Laboratory) Forms

      Research Checklist - start here (Word)

      Secured Fax Transmission Form (Word)

      Secured Print Transmission Form (Word)

      Outreach Printable Requisition Form - generic blank (PDF)

      Outreach Printable requisition Form - study sample (PDF)

Consent

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

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

Capacity Assessment Checklist for Research Informed Consent (PDF)

Epic Certification for Part 11 Compliance

21 CFR Part II Electronic Documention (EPIC) (PDF)

An example of EPIC EMR questionnaire for sponsors (Word)

UC Davis Epic Certification Letter for the FDA (PDF)

 Disclosure Tracking Database

            Spreadsheet for monthly bulk uploads (including instructions) (Excel)

            Disclosure Tracking Database

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

IT Evaluation Forms 

             Request for Exception from Technology Evaluation (Word)

 

 Radiology Procedure Request Form

             RAD Research Procedure Request (Word)

 

 UC Davis W-9

            UC Davis W-9 2015 (PDF)