Clinical Research Protocol The Principal Investigator Federal Regulations Preliminary Thoughts on Writing a Protocol Clinical Research Protocol: Initial Review Application Protocol Face Sheet Body of Protocol Clinical Center Resource Use
Clinical Research Protocol
The Principal Investigator
Federal Regulations
Preliminary Thoughts on Writing a Protocol
Clinical Research Protocol: Initial Review Application
Protocol Face Sheet
Body of Protocol
Clinical Center Resource Use
Office for Protection from Research Risks Office of Human Subjects Research Clinical Research Infrastructure Pre-IRB Scientific Review Institutional Review Boards Human Subjects Research Advisory Committee Medical Executive Committee Radiation Safety Program Radioactive Drug Research Committee Institutional Biosafety Committee Recombinant-DNA Advisory Committee Office of Recombinant-DNA Activities
Office for Protection from Research Risks
Office of Human Subjects Research
Clinical Research Infrastructure
Pre-IRB Scientific Review Institutional Review Boards
Pre-IRB Scientific Review
Institutional Review Boards
Human Subjects Research Advisory Committee
Medical Executive Committee
Radiation Safety Program
Radioactive Drug Research Committee
Institutional Biosafety Committee
Recombinant-DNA Advisory Committee
Office of Recombinant-DNA Activities
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 Informed Consent for HIV Testing Durable Power of Attorney
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
Informed Consent for HIV Testing
Durable Power of Attorney
Specifying the Objectives Measuring the Objectives Defining the Patient Population Study Design Randomization Stratification Determination of Sample Size Evaluation of Results Data Management Statistical Considerations in the Protocol Body Conclusion
Specifying the Objectives
Measuring the Objectives
Defining the Patient Population
Study Design
Randomization
Stratification
Determination of Sample Size
Evaluation of Results
Data Management
Statistical Considerations in the Protocol Body
Conclusion
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" Reporting an Adverse Experience Annual Progress Reports to the FDA
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
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"
Reporting an Adverse Experience
Annual Progress Reports to the FDA
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 Radioactive Drug Research Committee Amendment and Triennial Reviews
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
Amendment and Triennial Reviews
Pre-IRB Scientific Review Institutional Review Board Review Approval by the Clinical Center Director Expedited Review Activities Exempt from Institutional Review Board Review Human Gene Therapy
Institutional Review Board Review
Approval by the Clinical Center Director
Expedited Review
Activities Exempt from Institutional Review Board Review
Human Gene Therapy
Protocol Coordination Service Center Department of Clinical Bioethics Patient Recruitment and Public Liaison Office and Clinical Research Volunteer Program Medical Information System Medical Orders and "Per Protocol Order Sets" Data Gathering Clinical Information Utility Pharmacy Department Nursing Department Rehabilitation Medicine Department Clinical Pathology Department Nutrition Department
Protocol Coordination Service Center
Department of Clinical Bioethics
Patient Recruitment and Public Liaison Office and Clinical Research Volunteer Program
Medical Information System
Medical Orders and "Per Protocol Order Sets" Data Gathering Clinical Information Utility
Medical Orders and "Per Protocol Order Sets"
Data Gathering
Clinical Information Utility
Pharmacy Department
Nursing Department
Rehabilitation Medicine Department
Clinical Pathology Department
Nutrition Department
Continuing Review of a Protocol Clinical Research Protocol: Continuing Review Application Continuing Review Process Continuing Review Notification Memorandums Extensions Amendment Review of a Protocol Change of Principal or Medical Advisory Investigator Reporting Unanticipated Problems or Unexpected Harm
Continuing Review of a Protocol
Clinical Research Protocol: Continuing Review Application
Continuing Review Process
Continuing Review Notification Memorandums
Extensions
Amendment Review of a Protocol
Change of Principal or Medical Advisory Investigator
Reporting Unanticipated Problems or Unexpected Harm
Terminating a Protocol Informing Research Subjects
Terminating a Protocol
Informing Research Subjects
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
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
Figure 1: NIH-1195 Clinical Research Protocol: Initial Review Application Figure 2: Protocol Face Sheet 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 8: NIH-2514-3 Inclusion of HIV Testing in Consent to Participate in a Clinical Research Study 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
Figure 1: NIH-1195 Clinical Research Protocol: Initial Review Application
Figure 2: Protocol Face Sheet
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 8: NIH-2514-3 Inclusion of HIV Testing in Consent to Participate in a Clinical Research Study
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
Table 1: Eight Elements Mandatory in Every Protocol Consent Document Table 2: Additional Concepts for the Protocol Consent Document
Table 1: Eight Elements Mandatory in Every Protocol Consent Document
Table 2: Additional Concepts for the Protocol Consent Document
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