New! Orientation to Clinical Research Billing Course (#09155) is available through the LMS

  • Identify steps of the research billing process;
  • Determine what the study team must do to ensure compliance;
  • Your responsibilities for ensuring research billing compliance.

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)

Study Drug Administration Log (Word)

Medical History (Word)

Adverse Event Log (Word)

Another Adverse Events Log (Word)

Physical Exam (Word)

Daily Temperature Log (Word)

Laboratory Specimen Collection (Word)

Vital Signs (Word)

 

Study Management Tools

Adverse Events Database (template in Access) - courtesy of Neurosurgery

Patient Scheduler (template in Excel)

Appointment Calendar (template in Excel)

Subject Visit Tracking Log (Word)

Screening Log (Word)

Delegation of Responsibilities Log (Word)

On-going IRB documents checklist (Word)

Study Drug Accountability Log (Word)

Protocol Deviation Tracking (Word)

Subject Code List (Word)

Note to file (Word)

Progress Log (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)

 

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)

 

Radiology Procedure Request Form

RAD Research Procedure Request (PDF)

 

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

In September 2013 the FDA released the Guidance for Industry "Electronic Source Data in Clinical Investigations"  explicitly stating that the “FDA does not intend to assess the compliance of EHRs with Part 11.” The FDA guidelines defer the regulation of performance standards to 45 CFR Part 170, which is the foundation for the EHR certification requirements for Meaningful Use (MU). Therefore, Epic no longer releases documentation specifically for 21 CFR Part 11 certification, but the MU Certification document may be referenced in responses to sponsor questionnaires. 

       Download the current MU Certification document

       2015 MU Certification (PDF)

       An example of EPIC EMR questionnaire for sponsors (Word)

 

 

Disclosure Tracking Database

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

Disclosure Tracking Database (password protected)

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

 

IT Evaluation Forms

Request for Exception from Technology Evaluation (Word)

 

UC Davis W-9

UC Davis W-9 2015 (PDF)

 

IDS Fee Form (2015)

IDS Fee Form (Word)