The lead study team must provide the forms below to the relying site study team. The relying site study team is then responsible for completing and returning the following documents to the lead study team at initial review:

  • Site-specific study documents, such as consent and authorization forms and recruitment
    materials.

The documents below are tools that you as the lead study team may use to collect information from the relying site. The relying site study team would then be responsible for completing and returning the relevant document to the lead study team; these tools would be for your reference only and do not need to be submitted to the IRB:

Each relying site remains responsible for ensuring safe and appropriate performance of the research at their site. Relying site study teams are responsible for following their own institution’s process and requirements for relying on an external IRB, including completion of locally required ancillary reviews.

The relying site study team also is responsible for coordinating closely with you as the lead study team and promptly responding to your communications with them. For more information, see SMART IRB’s Relying Site Investigator Checklist.