| CITI training certificates | Required, in the modules Chamberlain currently names; current on the filing date. | Often requested; a site board may name modules of its own. | You complete the training; we check modules and dates and file the certificates in both packets. |
| The IRB application | Chamberlain’s current form, in Chamberlain’s current portal. | The site’s own facility or research application, in the site’s vocabulary. | Prepared by us; filed through your portal account with us on the line; the site’s packet filed to its board. |
| Consent or information sheet | Required elements as Chamberlain’s current guidance sets them. | Identical text; written to the stricter of the two reads. | Drafted by us; reviewed by you; one version in both files. |
| Recruitment materials | Flyers, scripts, emails as used. | The same materials, plus anything the site requires for its staff or patients. | Drafted by us to the plan; the site may require its own template. |
| Instruments and measures | Aligned to the QI aims and the measures named in the application. | The same instruments, with the site’s data-use terms reflected. | Yours where they are yours; aligned and appended by us. |
| Data-security plan | Storage, access, de-identification, retention, destruction. | The same plan, word for word; identifiable patient data is the line most site boards will not read past. | Drafted by us; one plan that reads the same on both boards. |
| Site permission letter | Appendix to the Chamberlain application. | Opens the site’s process; it is not the site’s approval. | Drafted by us for your site liaison’s signature. |
| Facility support letter | Often requested alongside the permission letter. | Commonly required in the site’s packet. | Drafted by us; signed by the site. |
| Data-use terms | Reflected in the data-security plan. | In the site’s language, matching what you will actually touch. | Drafted with the site’s research office; signed as the site requires. |
| Revision response | Point by point, tied to the revised page. | The same, on the site’s return. | Drafted and sent by us; the revised documents re-filed on both boards where they changed. |
| Amendments and continuing review | When the project changes, and for as long as it runs. | On whichever board asks. | Handled by us under Full Handover, on both boards. |