Currently Enrolling Trials • Staff • Committees & Workgroups • Contact Information

Investigators & Research Personnel

The OCR provides assistance to investigators and research personnel on all aspects of conducting an industry sponsored research study, including:

• Trial initiation assistance, including study feasibility assessment
• Financial administration, including budget development
• Contract negotiation
• Regulatory compliance
• Education and training           
• Marketing and outreach to sponsors and clinical research organizations

Getting started

• A Quick Overview - Steps to Conduct a Clinical Trial
• Checklist - Documentation Required by the Office of Clinical Research
• To Conduct or not to Conduct? That is the Question! UTMG OCR is the ANSWER
  An article by Laura Cummins and Alisa Firehock

• OCR Forms
  • Clinical Research Transmittal Form (Revised October 17, 2008)
  • Clinical Research Agreement - Sample Template
  • Standard Confidentiality Language and Guidelines
  • Protocol Feasibility Checklist
  • Clinical Trial Listing Form for UTMG Website        
• Responsibilities
  • OHRP Investigator Responsibility FAQs
  • OHRP informed Consent FAQs
  • OHRP Guidance on Continuing Review
  • Good Clinical Practice Program Mission statement

General Clinical Trial Information

• ClinicalTrials.gov

OCR Standard Operating Procedures/Policies

Educational/Training Materials

• Contact Derita Bran for more inforamtion at (901) 448-8279
  
• Online resource links for training:
  • CITI Training, Human Subject Protection Training
  • US Food and Drug Administration, Good Clinical Practices References
  • US Food and Drug Administration, Educational Materials about Good Clinical Practice and Clinical Trials
  • CenterWatch Training Series
  • NIH Clinical Center, The Department of Bioethics
  • NIH Videocasting, Past Events
  • NIH Clinical Center, Office of Clinical Research Training and Medical Education
  • OHRP Human Subject Assurance Training
• PowerPoint Presentations:
  • http://www.fda.gov/oc/gcp/slideshows/lepay2001/SQAWeb.ppt
  • http://www.fda.gov/oc/gcp/slideshows/2003/gcp2003.ppt
  • http://www.centerwatch.com/careers/addresources.html
  • http://www.orc.emory.edu/training/FDA_Inspections.ppt

HIPAA Resources

• Research Under HIPAA Resources
• UTHSC Research Under HIPAA — a presentation by Alisa Firehock and Rob Wilson, June 11, 2008

Regulations/Guidelines/Guidances

• Belmont Report
• Common Rule
• Declaration of Helsinki
  • Side-by-side comparison of 1996 and 2000 Declaration of Helsinki
• CFR Title 21 Database
• FDA
  • Center for Biologics Evaluations and Research (CBER)
  • Center for Device and Radiological Health (CDRH)
• Center for Drug Evaluation and Research (CDER)
• FDA CFR
• ICH GCP Guidelines
• Information Sheets
• Warning letters
• Guidance for Sponsors, Clinical Investigators, and IRBs Data Retention: When Subjects Withdraw from
  FDA-Regulated Clinical Trials Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials
• Nuremburg Code
• Office of Human Research Protections
  • Office of Human Research Protections - Questions and Answers
• Office of Research Integrity
  
• Draft Guidances
  • Guidance for Industry Protecting the Rights, Safety, and Welfare of Study Subjects Supervisory Responsibilities of Investigators DRAFT GUIDANCE
  • Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting — Improving Human Subject Protection DRAFT GUIDANCE
  • Guidance for Institutional Review Boards, Clinical Investigators and Sponsors Exception from Informed Consent Requirements for Emergency Research DRAFT GUIDANCE

Glossary/Medical Terms/Definitions/Abbreviations/Acronyms

• Agency for Healthcare Research and Quality Web-based glossary
• FDA Acronyms and Abbreviations
• Medline Plus Medical Dictionary
• U.S. Department of Health & Human Services Dictionary
• Health Topics

Institutional Review Boards

• UTHSC IRB
• Western IRB
• Methodist Healthcare IRB

Examples of Clinical Trial Tracking Forms

• Adverse Event Tracking
• Communication
• Concomitant Medication
• Investigational Product Dispensing/Accountability Record
• IRB Submission Tracking
• Protocol Amendment Tracking
• Record of Subject Communication
• Subject ICF Tracking
• Versions of ICF
• Delegation of Authority Form

Clinical Trial Tools

• Abbreviations/Acronyms
• Height Conversion Table
• Military Time Conversion Table
• Research Related Terms
• Temperature Conversion Table
• Body Surface Area Calculator
• Lay Terms for the Informed Consent