Salus IRB template study documents are designed to assist in the preparation of the proposed protocol and informed consent documents. The templates include the required elements of informed consent, according to 21 CFR 50.25, 45 CFR 46.116, and ICH Guidelines.
Although not required, utilizing these tools minimizes the need for extensive changes to documents, allowing for the fastest review and turnaround.
To request template study documents, contact Client Services.