Within SimpleTrials you can both add your own signature to a document or send a document for signature to another person using DocuSign. To add your signature to a document (i.e. signing the Clinical Monitoring Plan) complete the following steps:
- Navigate to the DOCUMENTS / eTMF view
- Select the document record (you may need to expand multiple folders to get the specific record)
- Ensure the document file has been uploaded to the document record. NOTE: You may want to electronically sign the record first.
- Once you select the document record scroll to the DocuSign section
- Select "Open in DocuSign"
- Before being taken to the DocuSign site, you will be prompted to select either Self Sign or Send for Signature
- To sign the document yourself, select "Self Sign"
- After entering this basic information, you will be directed to DocuSign to complete the steps to input your signature within the document.
Once the document has been signed, the "Most Recent DocuSign Action" will populate with the details.
Users Access Requirements | Admin, Manager, Associate, Document Manager, |
Portfolio View Access Requirements | All Data, Studies + General Records, Studies Only, Sites Only |
Subscription Requirements | Trial, Premium, Premium for Sites, Premium Plus, Enterprise |
Glossary | |
DocuSign | A platform that allows you to input an image of your signature onto a document that integrates with SimpleTrials |
Electronic Records Signature | Verifies the details of the SimpleTrials user who authenticated a record or file for 21CFR Part 11 compliance. Any changes made to the file will break this signature. |
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