When you consent a patient whose surgeon and procedure match an active study, you can enrol them in the study and capture informed consent as part of the same consent form, or on the patient profile.
Consenting for a study during the surgery consent
Open the patient in Registration & Consent and continue their Consent and Admission Request Form, with the procedure, surgeon and hospital selected as usual.
Locate the Studies option in the consent form and tick it to include a study. Select the relevant study from the list. Only studies that match the selected surgeon, procedure and hospital are shown.
Review the PICF and provide informed consent. The study's PICF appears as a link. Open it and take the patient through informed consent as required by the study protocol.
⚠️ Important: Providing informed consent is a clinical responsibility. OrthoMate presents the approved PICF and records the signatures — it does not replace the informed‑consent conversation.
Select the participant's cohort (the study label, for example treatment or control) from the options configured for the study.
Complete the informed‑consent details:
- Person informing consent — name, signature and date.
- Patient — name, signature and date.
On completion, OrthoMate generates the signed PICF, with its final signature page, that will be sent to the patient and the clinic email address.
Consenting for a study on the patient record
- Click the patient's name in the patient list to open their record.
- Scroll to the Study Consent section and tick Include study consent. All active studies are listed. Check the patient meets the study's eligibility criteria before starting.
- Next to the study, click Begin study consent and follow the same steps as above.
Each study needs its own PICF review and decision. Only a completed, signed study consent confirms enrolment. Declining doesn't enrol the patient and doesn't affect their care.
After the study consent is signed
In the Study Consent section, each study shows its status (for example Consented) and whether the signed PICF has been sent to the patient and the clinic. From here you can Open signed PICF, Resend copies or Manage study consent. The signed PICF is also saved under Documents on the patient record.