Translational Clinical Research

Clinical Trial Designing and Management References

Oct 29, 2012

FDA and Clinical Trials

Mimi Riley, UVA School of Law, at the Darden Life Science BootCamp, April 16 2010.

Labels: Clinical Trials, FDA

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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FDA Clinical Trial Draft Guidance Documents : GCP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

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Alliance for paired donation

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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