Translational Clinical Research

Clinical Trial Designing and Management References

Jan 7, 2013

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Clinical Study Guidelines & Regulations

  • Non-local IRB Review
  • 21 CFR 314 applications for FDA approval to market a new drug
  • 21 CFR 312 investigational new drug application
  • 21 CFR 50 protection of human subjects (FDA)
  • 45 CFR 46 protection of human subjects (HHS)
  • Comparison of FDA and HHS human subject protection regulations
  • 21 CFR 54 finical disclosure by clinical investigators
  • 21 CFR 56 institutional review boards
  • 21 CFR 812 investigational device exemptions (IDE)
  • 21 CFR 820 quality system regulation
  • AHRG guideline: Machine perfusion & cold storage of kidney from deceased donors storage of
  • Adaptive Design Clinical Trials for Drugs and Biologics
  • Common Terminology Criteria for Adverse Events (CTCAE)
  • Comparison of FDA and HHS Human Subject Protection Regulations
  • Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects
  • Device Advice: Comprehensive Regulatory Assistance
  • FDA Clinical Investigator Training Course 2011
  • FDA Clinical Trial Draft Guidance Documents : GCP
  • FDA Device comprehensive regulatory assistance
  • FDA For Health Professionals Topics
  • FDA Guidance on IDE Policies & Procedures
  • FDA Guidance:Safety Reporting Requirements for INDs and BA/BE Studies -- Small Entity Compliance Guide, Dec. 2012
  • FDA IDE Tutorial for Academic Investigators
  • FDA Master Files for Devices (MAFs)
  • FDA Medical Device Cross-Center Guidance Documents
  • FDA Training and Continuing Education
  • FDA guidance for IDE application
  • FDA guidance: Safety Reporting Requirements for INDs and BA/BE Studies Dec. 2012
  • FDA guideline and regulation: IDE Approval Process
  • FDA's HSP/BIMO Initiative Accomplishments: Update May 2012
  • FDA: How Drugs are Developed and Approved
  • Guidance for Industry Non-Inferiority Clinical Trials
  • Guidance on Exculpatory Language in Informed Consent (Aug. 2011)
  • HHS.gov -- Policy & Guidance
  • Human Subject Regulations Decision Charts
  • Information Sheet Guidance for Institutional Review Boards (IRBs), Clinical Investigators, and Sponsors
  • Medical Device Cross-Center Guidance Documents
  • Medical Device Quality Systems Manual
  • NHS (uk) -- Kidney Transplantation
  • ORA University State Training Courses and Training Materials
  • Progress & Challenges in Efficacy, Safety, and Paths to IV Immune Globuline (FDA, 2005)
  • Quality System (QS) Regulation/Medical Device Good Manufacturing Practices
  • Statistical Guidance for Clinical Trials of Non Diagnostic Medical Devices
  • The Belmont Report
  • US Patent and Trademark Office
  • Waived Test

Renal Transplant Useful Links

  • FDA 510(k) applications and decisions collected since 1996
  • FDA requirements for IDE sponsors
  • Flow Cytometry Introduction 1 (Invitrogen)
  • Flow Cytometry Introduction 2 (Invitrogen)
  • Induction Therapy in Kidney Transplantation

Study Management Tools

  • FDA Audit Preparation Resource & Checklist - Johns Hopkins 2013
  • FDA Guidance -- A Risk-Based Approach to Monitoring
  • Strategies for Clinical Investigators to Build Quality into Device Research
  • National Coverage Determination (NCD) for Routine Costs in Clinical Trials (310.1)
  • Billing for Patient Care in Clinical Research Studies
  • REGULATORY DOCUMENTS -- UT Health Science Center at Houston
  • What Makes A Top 10 Site
  • Strategies for Clinical Investigators to Build Quality into Device Research
  • NEGOTIATING CONTRACTS FOR CLINICAL TRIALS
  • Clinical trial design — for beginners
  • FDA GCP training
  • Clinical Research Forum
  • SOPs
  • CTN clinical trial tools, templates, training

Research Methodology

  • Comparative effectiveness research
  • Design and Analysis Clinical Trials
  • NIH guidelines for writing research protocols
  • NIH Stem Cells: Scientific Progress and Future Research Directions
  • Prepare a protocol for the study

Translational Clinical Research Institute Links

  • Childern's Hospital Boston
  • Clinical Research Networks
  • Duke
  • National Electronics Clinical Trials and Research
  • NIH CTSA
  • Resources for Researchers
  • The Institute for Translational Sciences -- UTMB
  • UC San Diego CTSI
  • UCDHS CTSC
  • UCLA CTSI
  • UCSF Clinical Research Resource HUB
  • UCSF CTSI

Clinical Trials at UC Davis

  • Accounts Receivable
  • CCRC Accessing Support Process
  • Clinical Research Billing Education Series
  • Clinical Research Quality Assurance Program for Investigator-Initiated Interventional Trials, UC Davis
  • Clinical Trials Contracts
  • Composite Benefit Rate
  • Indirect Cost Rate Applicable to Clinical Trials
  • UC Davis IRB Guidance
  • Home
  • Renal Transplant Study References
  • Health & Aging

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Reading List

  • A Clinical Trials Manual From The Duke Clinical Research Institute: Lessons from a Horse Named Jim -- Margaret Liu
  • A Manager's Guide to the Design and Conduct of Clinical Trials -- Phillip I. Good
  • Applied Survey Data Analysis -- Steven G. Heeringa
  • Clinical Epidemiology: How to Do Clinical Practice Research -- R. Brian Haynes
  • Clinical Evaluation of Medical Devices: Principles and Case Studies -- Karen M. Becker
  • Clinical Research Coordinator Handbook -- Deborrah Norris
  • Clinical Trial Methodology -- Karl E. Peace
  • Design, Execution, and Management of Medical Device Clinical Trials -- Salah Abdel-aleem
  • Goodman and Gilman's The Pharmacological Basis of Therapeutics -- Laurence Brunton
  • Guidebook for Drug Regulatory Submissions -- Sandy Weinberg
  • Principles and Practice of Clinical Trial Medicine -- Richard Chin
  • Statistical Evidence in Medical Trials: Mountain or Molehill, What Do the Data Really Tell Us? -- Stephen Simon
  • Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics -- Linda Fossati Wood
  • The CRA's Guide to Monitoring Clinical Research -- Karen E. Woodin

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