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*Quick Reference*
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Budget Development
Budget Development Process

Clinical Trial Budget Templates


Price Lists
Federal and Non-Federal UT Clinical Services
CRU Budget Template and MHH Ancillary List
MHH Ancillary List Only

Consent Writing Tools and Guidance
NIH Guidance
Online Readability Tool (insert your wording for readability statistics)
PlainLanguage.gov (glossary of simplified words)
PRISM Readability Toolkit
Web Based Instruction on Informed Consent (U of Minn)


Research Billing
Clinical Research Billing Business Process
Research Account Setup
UT Health Clinical Trials Services Charge Document UT Health Clinical Trials Charge Document *Log*
UT Health Case Billing Request Form
Inpatient/Hospital Clinical Research Billing for UT services
UT Health Compliance Program for Clinical Research Billing
- Clinical Research Billing Compliance Plan Template
- Department Clinical Trials Responsibility Log

Study Initiation, Protocol Preparation, and
Study Management/Termination

Adverse Event Tracking Log (Example A, B)
Chart Review Checklist
ClinicalTrials.gov information (link to website)
CPHS Communication Log
Consent Document Template
Developing a Data and Safety Monitoring Plan (link)
Developing a Data and Safety Monitoring Board (link)
Device Accountability Log
Drug Accountability Log
Financial Management Worksheets
Master Subject Log
Monitoring Log
Policy Procedures Template
Protocol Development and Templates (link)
Protocol Deviation Tracking Log
Protocol Feasibility Policy
Quality Management Log
Quality Management Plan
Quality Management Plan Template (DMID)
Regulatory Binder Essential Contents
Regulatory Binder Review Checklist
Schedule of Study Visits
Screening and Enrollment Log
Signature and Delegation of Duties Log
Site Specific SOPs
Specimen Log
Study Feasibility Checklist
Study Initiation Policy Template
Study Worksheet Template
Subject Contact Log
Subject Screening and Enrollment Log
Subject Visit Schedule Log
Training Log


Termination of a Study
Study Closeout Checklist
Letters to Participants

FDA and Site Inspections Documents
*Notify UTHSC designees that you are being inspected here*

General Guidance for Site Inspections
FDA Inspection Information
FDA Pre-Inspection Checklist
FDA Inspection Reporting


FDA Forms
(Please note that expired forms are okay to use if new ones have not yet been issued by the Agency. *FDA has OMB approval to use these forms until 8/31/2011)

*1571 - Investigational New Drug Application
*1572 - Statement of the Investigator
3454 - Certification: Financial Interest and Arrangements of
Clinical Investigators
3455 - Disclosure: Financial Interest and Arrangements of
Clinical Investigators
3500A- Medwatch Mandatory Reporting for Drugs and Devices
3674 - Certification of Compliance with Requirements of
ClinicalTrials.gov Data Bank
Investigator of Record Declaration for Device Studies
(Not an FDA form, but functions like a 1572 for device studies)


Validation and Compliance with 21CFR Part 11
UTHSC Validation information

Certificates of Confidentiality (links)
Certificates of Confidentiality Kiosk
Background Information
Application Instructions for Extramural Research

FAQ

Research Records Retention Information
State of Texas Record Retention Policy (Medical School)
UTHealth Records Retention Schedule
CPHS Record Keeping
21 CFR 312 Subpart D- Responsibilities of Sponsors and Investigators

Billing and Department Contacts
Contact list

Glossary and Acronyms
(links)
NIH- glossary
NIH – activity code listing
NIH- acronym list

ResearchMatch at UTHSC

ResearchMatch.org Information

Go to:
Study Management Tools Page

Your Portal to Best Practices in Clinical Trial Management
EMAIL: CLINICALTRIALS@UTH.TMC.EDU PHONE: 713-500-3622 FAX 713-500-0334
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