(DFCI-specific) Adobe Sign for Electronic Consents and Regulatory Documents

October 02, 2020

*The resources below are intended for use by DFCI research personnel only.*

The following resources have been developed by the DFCI Clinical Trials Office in collaboration with the DF/HCC Office of Data Quality and the DF/HCC Office for Human Research Studies. These resources reflect DFCI-specific systems and institutional policies that may not be applicable at other DF/HCC institutions. 

Training Courses

e-Learning Course on Using Adobe Sign for Obtaining Informed Consent 
(25 minutes)
This training is intended for DFCI research teams and covers the regulations and requirements for electronic signatures and informed consent, provides an overview of the process, and step by step instructions for preparing and sending consent forms for signature.

e-Learning Course on Using Adobe Sign for Regulatory Documents
(25 minutes)
This training is intended for DFCI research teams and provides instructions and case study examples for using Adobe Sign to electronically complete and sign regulatory documents including INDSRs, Covers Letters, Attestation Forms, and DOA Logs.

Additional Resources:

Guidance: Adobe Sign for Electronic Consent
A comprehensive guidance developed by the DFCI CTO that provide step by step instructions, screen shots, and helpful tips for study teams using Adobe Sign for informed consent.

Demo e-Learnings
Short videos (~3-5 minutes each) showing how to prepare and send a consent form in Adobe Sign. 
Topics:
- Logging into Adobe Sign and Completing the "Send" Page
- Adding Signature/Date Fields for Multiple Signers
- Using Radio Buttons and Adding Conditions (i.e. for optional studies requiring initial and date)
- Using Text Input Fields, Checkboxes, and Pre-Filling Fields as the Sender (i.e. for the documentation section)

Coming Soon:
Please contact the DFCI CTO with questions about these documents, and the appropriate language to provide research subjects.

Adobe Sign Instructions for Research Participants
Approved standard language that may be sent to potential research participants explaining how to sign a consent form using Adobe Sign
Note - any study-specific modifications to this language must be approved by the IRB prior to being shared with patients

Guidance and Approved Language for Messages/Reminders Sent to Participants in Adobe Sign
This guidance document will provide standard approved language for the Message field when sending a consent form to a research participant as well as best practice and approved language for sending a reminder to sign to the participant via Adobe Sign.
Note - any study-specific modifications to this language must be approved by the IRB prior to being shared with patients.

Please contact ODQEducation@dfci.harvard.edu with questions.