Program on Prevention Outcomes and Practices

IRB eProtocol Checklist

Title: ________________________________________________          

Protocol ID: _____                                                                                             

Review Type: __________

q  Personnel Information

q  Participant Population(s) Checklist

q  Study Location(s) Checklist

q  General Checklist

q  Funding Checklist

Resources

          q Qualified Staff

          q Training

          q Facilities

          q Sufficient Time

          q Access to Target Population

          q Access to Resources

          q Lead Investigator

Protocol Information

          q  Expedited Paragraphs   [Title, Type of Study]

          q  1-3                             [Purpose, Study Procedures, Background]

          q  4                                [Ratioisotopes or Radiation Machines]

          q  5,6                             [Devices, Drugs, Reagents or Chemicals]

          q  7                                [Medical Equipment]

          q  8 (a-g)                        [Participant Population]

          q  8 (h-m)                       [Participant Population continued]

          q  9 (a-d)                        [Risks]

          q  9 (e)                           [Risks – Special Participant Populations]

          q  10, 11                        [Benefits, Procedures for Confidentiality]

          q  12                              [Potential Conflict of Interest]

          q  13                              [Consent]

          q  14                              [Assent]

          q  15                              [HIPAA]

          q  16                              [Attachments]

 

q  Obligations                           [Protocol Director Obligations + agreement]

q  Submit Protocol                                                 q  Protocol approved

          Date submitted: ____________                                Date approved:  ____________

 

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