Participants sometimes require the support of others to participate in or complete a study. You may need to share documents with these individuals or require them to sign forms on behalf of the participant. To complete these tasks, you can create signatory records.
Signatory Roles
Each patient has different support needs; select the appropriate signatory for your participant’s specific situation.
| Signatory | Description | Multiple Instances |
|---|---|---|
| Caregiver | Provides direct support in participant adherence and can sign alongside or on behalf of the Participant depending on how the document is configured. | Multiple caregiver signatory records can exist for a participant, but note that a maximum of two Caregiver signatures can be added to eConsents where multiple caregiver signatories are needed. |
| Guardian / LAR | Individual legally authorized to consent on behalf of the participant (ex., minor, incapacitated adult). Guardian/LAR signatories can sign alongside or on behalf of the Participant depending on how the document is configured. | Multiple guardian signatory records can exist for a participant, but note that a maximum of two Guardian signatures can be added to eConsents where multiple guardian signatories are needed. |
| Proxy | A person legally designated (ex., via Power of Attorney) to make medical decisions, including research participation, for an incapacitated adult. SiteVault prevents sending consent forms to a Proxy and Participant at the same time. A proxy signs on behalf of the Participant, never in addition to the Participant. | N/A |
| Translator | Facilitates accurate communication between the investigator and the participant/LAR when languages differ. | N/A |
| Witness | An impartial person who observes the consent process to attest that the information was explained and apparently understood (often for illiterate participants). A witness is a general co-signer that does not fit within the role of Proxy, Guardian/LAR, or Translator. | Multiple witness signatory records can exist for a participant, but please note that a maximum of two Witness signatures can be added to eConsents where multiple witness signatories are needed. |
Add a Signatory
Complete the steps below to add a signatory:
- Navigate to Studies.
- Select a study.
- Select the Participants tab.
- Select a participant.
- Select the Signatories tab.
- Select + Add Signatory.
- Complete the required and any additional fields.
- Select Save.
