You must include only one of each of the following types of documents for original submission of Complete trials:
Protocol document (complete protocol)
IRB Approval
Informed consent and participating site documents are optional and can be uploaded if relevant information is not included in the Protocol document.
You must include only one each of the following types of documents for each submission of trial amendments:
IRB approval
Informed consent
Protocol highlight change
Participating site documents (if appropriate)
Amended protocol and/or Change memo (summary of changes to the protocol)Â
You are required to supply your documents as Microsoft Word, Adobe PDF, Microsoft Excel, or WordPerfect files.
For instructions, refer to the following pages:
