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Prospective Clinical Trials Involving the Consent Process: Helpful Tools
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Study Personnel Education/Training
Delegation of Responsibility
IRB Decisions/IRBNet Submission Forms
IRB Correspondence
Protocol
Consent
Public Registration of Research Studies
Screening and Enrollment Log
Form 1572, 1571
Protocol Deviations
Unanticipated Problem
Serious Adverse Events
Adverse Events
Advertising Materials
Lab Certificates/Reference Range
Tracking Lab Samples and Shipping
Investigational Product
Study Team Correspondence/Sponsor Correspondence
Helpful Tools
Forms
Study feasibility checklist
IRB submission checklist
Consent form checklist
Freezer temperature log
Refrigerator temperature log
Research Language & Definitions
Telephone Log
Study supply log
Study termination worksheet
Subject schedule
Study amendment tracking log
Concomitant medication log
Research Progress Note
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Study Team Correspondence/Sponsor Correspondence