Obtain IRBs Sample Clauses

Obtain IRBs. ECs Approval Documentation‌ In order to link the IRB/EC approval letter(s) to the current DAIDS-approved version of the protocol, documentation from each IRB/EC of approval must reference the following: • DAIDS ES and/or Network protocol ID number • Full protocol title • Protocol version number and/or date • The approved informed consent forms, version number and date • Risk/benefit category if research involves pregnant women, children or adolescents (see Section 8.5.6 for more information) • Effective date of IRB/EC approval • Signature of the IRB/EC Chair or designee • Title of the person signing for the IRB/EC It is recommended, but not required, that the expiration date of the approval also be included. If the approval documentation is provided in a language other than English, the document must also be translated into English.
Sample 1
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