Protomechanics. Guide for preparing and conducting clinical research study.
Foreword
Note from the Editor
Chapter I. GUIDELINES FOR PROTOCOL PREPARATION
Preliminary Thoughts on Writing a Protocol
Chapter II. OFFICES AND COMMITTEES INVOLVED
Office for Protection from Research Risks
Office of Human Subjects Research
Clinical Research Infrastructure
Human Subjects Research Advisory Committee
Radioactive Drug Research Committee
Institutional Biosafety Committee
Chapter III. INFORMED CONSENT AND ASSENT
What are Informed Consent and Assent?
Protocol Consent Document and Required Elements
Assent Document and Required Elements
Editing the Protocol Consent and Assent Documents
Electronic Protocol Consent and Assent Document
Chapter IV. STATISTICAL CONSIDERATIONS FOR PROTOCOLS
Defining the Patient Population
Chapter V. PROTOCOLS USING INVESTIGATIONAL NEW DRUGS OR DEVICES
Use of Test Articles in the Clinical Center
Circumstance A. Use of an Investigational New Drug in a Clinical Research Study
Circumstance B. Use of an Investigational New Drug for Individuals Who Do Not Meet Protocol Criteria
Circumstance C. Use of an Approved Drug in a Clinical Research Study
Circumstance D. Use of an Approved Drug in an Unapproved Manner in the Practice of Medicine
Filing an "Investigational New Drug Application"
Chapter VI. PROTOCOLS USING RADIATION FOR RESEARCH
Ionizing Radiation Usage: Medically Indicated or Indicated for Research Purposes
Authorized User and Individual User of Radioactive Materials
Informed Consent for Radiation Exposure
Radiation Safety Committee Review
Chapter VII. APPROVAL PATH OF NEW PROTOCOLS
Institutional Review Board Review
Approval by the Clinical Center Director
Chapter VIII. CLINICAL CENTER SERVICE ELEMENTS
Protocol Coordination Service Center
Department of Clinical Bioethics
Patient Recruitment and Public Liaison Office and Clinical Research Volunteer Program
Chapter IX. ONGOING REVIEW OF THE PROTOCOL
Continuing Review of a Protocol
Clinical Research Protocol: Continuing Review Application
Continuing Review Notification Memorandums
Amendment Review of a Protocol
Chapter X. TERMINATION OF A PROTOCOL
Chapter XI. CONCLUSION
Protocol Checklist for Initial Reviews
Protocol Checklist for Continuing Reviews
Protocol Consent and Assent Document Checklist
Appendices
Appendix A: Common Toxicity Criteria
Appendix B: Protocol Map Planning Purposes
Appendix C-1: Lay Language and Terms
Appendix C-2: Lay Descriptions of Common Research Procedures
Appendix C-3: Clinical Research Concepts
Appendix D: Investigational New Drug Application
Appendix E: Statement of Investigator
Appendix F: Application for Authorization to Use Radiation in Research Involving Human Subjects
Figures
Figure 1: NIH-1195 – Clinical Research Protocol: Initial Review Application
Figure 3: Compensation for Healthy Clinical Research Volunteers
Figure 4: Institutional Review Board Chairs and Protocol Coordinators
Figure 5: NIH-1225-1 – General Admission Consent
Figure 6: NIH-2514-1 – Consent to Participate in a Clinical Research Study
Figure 7: Consent to Participate in a Clinical Research Study: Signature Page
Figure 9: NIH-200 – Durable Power of Attorney
Figure 10: Authorization to Administer Radiation in Research Involving Human Subjects
Figure 11: The Protocol Approval Process
Figure 12: Request for Review of Research Activity Involving Human Subjects
Figure 13: NIH-1195-1 – Clinical Research Protocol: Continuing Review Application
Figure 14: NIH-2704 – Request for Change of Principal Investigator and/or Medical Advisor
Figure 15: NIH-527 – Authorization for the Release of Medical Information
Tables
Table 1: Eight Elements Mandatory in Every Protocol Consent Document
Table 2: Additional Concepts for the Protocol Consent Document
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