- Identify & Verify Timing: Ensure the patient is identified within 90 days of a confirmed complete response—calculated from the date of their MDT discussion, MRI report, or post-op pathology report. Eligible cohorts now include Clinical Complete Response (cCR) on Watch & Wait, clinical near-complete response, pathological complete response (pT0), or cCR patients who proceed directly to surgery.
- Provide Information: Hand the patient the approved Patient Information Sheet (v2.0) and answer any questions they may have. If consenting remotely, discuss the database via a telephone or video call first, then email or post the information sheet and consent form to them.
- Obtain Consent: If the patient is happy to proceed, obtain written consent using the approved Patient Consent Form (v2.0). Give one copy to the patient, file the original securely in your local site file, and ensure remote patients return their signed form so you can countersign it.
- Request a Patient Study ID: Securely email a copy of the signed consent form and confirmation of the patient’s NHS number to lee.malcomson@nhs.net. Note: You must have this unique pseudonymised Study ID from the Data Manager before you can enter any data into REDCap.
- Complete Online Registration: Once you have the Study ID, log into the REDCap Registration Link. Select your NHS Trust, enter your site contact email address, input the Participant ID, and fill out the baseline clinical data.
- Submit and File: Submit the online form to complete the registration. You will receive an automated email confirmation with a downloadable PDF copy of the completed proforma to print and keep in your local site file.
- Await Automated Follow-Ups: Do not submit manual follow-up forms. Approximately every 6 months, the registered site contact email will receive an automated message from REDCap containing a unique, secure link to update that specific patient’s follow-up data online.
- Thank you for taking the time to submit to the OnCoRe Research Database!
Thank you for taking the time to submit to the OnCoRe Research Database
