Transcription of WCG IRB Guide for Researchers
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WCG IRB Guide for Researchers
WCG IRB Guide for Researchers Rev 23 December 2021 WCG IRB Guide for Researchers | Rev 2 Revised in this version: Add information about billing information stand alone form WCG IRB Guide for Researchers | Rev 3 Contents WCG IRB Guide for Researchers .. 1 Introduction .. 8 Working with WCG IRB for IRB Review - An Overview .. 8 Submitting Documents for IRB Review .. 9 Materials Required for Initial Review .. 9 Items Required for All Initial Review Requests .. 9 For drugs, biologics and food supplements .. 9 For device studies: .. 9 Regulations Affecting Clinical Research, Including HIPAA: The Regulatory Framework Within Which WCG IRB Functions .. 10 HIPAA .. 11 Conflicts of Interest .. 11 Amount of Risk .. 12 Effect of the Conflict of Interest on Subjective Decision-Making.
• Curriculum Vitae (CV) for principal investigator • Consent Form (If WCG IRB has not already approved one). Please submit consent forms as Microsoft Word compatible files (.doc, .docx, .rtf). • Other Materials to be Provided to the Participantswhich are not included in the protocol,
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