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eConsent

Create an informed consent form and share it with participants.

Last updated

July 7, 2022

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When doing clinical research you may subjects to sign an informed consent form (ICF).

Teamscope has an eConsent solution that makes getting consent digitally and remotely very easy.

Important: To use eConsent you will need the Business plan.

How to add eConsent to your study

To add eConsent to your study go to Forms on the web dashboard and select the form where you want a consent signature.

Inside your form add the Signature field type.

From here you may set a required number of signatories. The minimum value is 1.

After adding the signature field click on Save.

How the signing process works

Now that you have added a signature field you can give it a try.

To try it out go to Data, then New entry and finally choose in which you added the Signature field.

You will see that on the signature field you can:

  • Sign directly
  • Invite a signatory

What happens when you invite a signatory

The signatory will get an email invitation to sign. If the signatory does not have an account yet created they will first be asked to create an account and then sign the form.

Right under the signature field you can see the full history if this forms signature flow. The following events are registered with a timestamp.

Revoking after signing

Any of the signatories can revoke their consent after having signed. To do this all they need to do is click on “Revoke consent”.

Exporting eConsent data

To export your data you must go to Exports and choose the form that has the signature field in it.

When exporting it this is how the data is presented:

This data format is called JSON and you can see it in easier way by pasting it on this link: http://jsonviewer.stack.hu/

Frequently asked questions

Can I export a PDF copy of the signed form?

Unfortunately not at the moment. If you need also a PDF copy please let us know (support@teamscopeapp.com) and we are happy to give this feature request a higher priority.

I see that on the form there is a field to send an email invitation to a signatory, will participants also see this?

No, only user with Edit cases permission can invite a signatory. For users without that permission the add signatory field is hidden and the only thing they can do is enter their own signature.

Can the participant make changes to other fields in the form or only enter their signature?

This depends on the how you have setup the signature logic, on the form builder you can specify if the invitee should only be allowed to enter signature or also change the data on other fields.

I see that there is a status of the signatures, is that the full history or only the last status per signatory?

On the form the platform only displays the last status per signatory. This means that if John signed today at 14:00 and then at 15:00 he revoked the signature, under the status it will only appear that John revoked the signature at 15:00.

What happens if two users sign at the same time?

If both users have the blank form open and then they sign at the same both signatures won’t be combined and when refreshing the form you will see the status of all signatories regardless when they signed or if all signed at the same exact same time.

If a user revokes can they sign it again?

Yes. The user does not need to be invited again, they can simply open the form and sign it again.

What permission does a user need to have to be able to invite other users to sign a form?

Only users that have the permission “edit cases” can invite others users to sign a form with eConsent.

Limitations

  • Currently the signing history can only be seen inside the entry and not in the activity log.

When doing clinical research you may subjects to sign an informed consent form (ICF).

Teamscope has an eConsent solution that makes getting consent digitally and remotely very easy.

Important: To use eConsent you will need the Business plan.

How to add eConsent to your study

To add eConsent to your study go to Forms on the web dashboard and select the form where you want a consent signature.

Inside your form add the Signature field type.

From here you may set a required number of signatories. The minimum value is 1.

After adding the signature field click on Save.

How the signing process works

Now that you have added a signature field you can give it a try.

To try it out go to Data, then New entry and finally choose in which you added the Signature field.

You will see that on the signature field you can:

  • Sign directly
  • Invite a signatory

What happens when you invite a signatory

The signatory will get an email invitation to sign. If the signatory does not have an account yet created they will first be asked to create an account and then sign the form.

Right under the signature field you can see the full history if this forms signature flow. The following events are registered with a timestamp.

Revoking after signing

Any of the signatories can revoke their consent after having signed. To do this all they need to do is click on “Revoke consent”.

Exporting eConsent data

To export your data you must go to Exports and choose the form that has the signature field in it.

When exporting it this is how the data is presented:

This data format is called JSON and you can see it in easier way by pasting it on this link: http://jsonviewer.stack.hu/

Frequently asked questions

Can I export a PDF copy of the signed form?

Unfortunately not at the moment. If you need also a PDF copy please let us know (support@teamscopeapp.com) and we are happy to give this feature request a higher priority.

I see that on the form there is a field to send an email invitation to a signatory, will participants also see this?

No, only user with Edit cases permission can invite a signatory. For users without that permission the add signatory field is hidden and the only thing they can do is enter their own signature.

Can the participant make changes to other fields in the form or only enter their signature?

This depends on the how you have setup the signature logic, on the form builder you can specify if the invitee should only be allowed to enter signature or also change the data on other fields.

I see that there is a status of the signatures, is that the full history or only the last status per signatory?

On the form the platform only displays the last status per signatory. This means that if John signed today at 14:00 and then at 15:00 he revoked the signature, under the status it will only appear that John revoked the signature at 15:00.

What happens if two users sign at the same time?

If both users have the blank form open and then they sign at the same both signatures won’t be combined and when refreshing the form you will see the status of all signatories regardless when they signed or if all signed at the same exact same time.

If a user revokes can they sign it again?

Yes. The user does not need to be invited again, they can simply open the form and sign it again.

What permission does a user need to have to be able to invite other users to sign a form?

Only users that have the permission “edit cases” can invite others users to sign a form with eConsent.

Limitations

  • Currently the signing history can only be seen inside the entry and not in the activity log.

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