Audience: Sage employees, including Challenge administrators and ACT

Table of Contents:

Resources, Definitions, & People

Resources

Challenge overview/infrastructure

Challenges homepage

Challenge Cheat Sheet

Challenge Terms

• MOU - memorandum of understanding (for conditions for use - make sure to get pre and post conditions for use) 

• DTA - Data Transfer Agreement (DTAs are legal contracts governing the transfer of non-human or de-identified data)

• DSA - Data Sharing Agreement (DSAs justify data sharing and are very similar to DUAs)

• DUA - Data Use Agreement (DUAs are subject to HIPAA and often require an IRB approval)

• DTUA - Data Transfer & Use Agreement (DTUAs govern how data is shared. Sage often uses the Data Transfer & Use Agreement templates developed by the Federal Demonstration Project)

• DREAM - Dialogue for Reverse Engineering Assessments and Methods

Sage Challenge Administrators

• Computational Oncology Challenge Facilitator: Julie Bletz

• Systems Biology Challenge Facilitators: Larsson Omberg, Solly Sieberts

• Challenge Regulatory Governance Team: Hayley Sanchez, Vanessa Barone

• Access & Compliance Team (ACT): Emily Lang

Processes for Establishing Challenge Governance

Challenge Process Overview

1. The Challenge Admin, a member of either Computational Oncology or Systems Biology, sets up a Challenge Team and Challenge staging site, referencing the templates outlined here.

2. The Challenge Admin contacts the Governance Team to begin the Challenge governance setup process. This can be done via email or during the Regulatory Governance standing meeting with Computational Oncology if applicable. When reaching out to Governance, the following should be included:

   1. Challenge overview

   2. Link to staging project(s) and team(s)

   3. Any applicable regulatory documents (e.g. IRB approval document)

3. The Challenge Admin introduces the Regulatory Governance contact to the Challenge Data Contributors via email.

   1. The Regulatory Governance contact creates a Jira ticket and tags ACT (currently Emily Lang) for awareness 

   2. The Regulatory Governance contact emails contributors with a data hosting questionnaire

4. The Regulatory Governance contact receives the completed data hosting questionnaire and creates a DTA/other agreement based on the questionnaire info. The fully executed agreement must include a post-Challenge terms and conditions of data use section. This section should be completed by the Data Contributors. 

5. The Regulatory Governance contact identifies terms to be included in the Challenge click-wrap. ACT is then looped in to establish the click-wrap. 

6. ACT sets up click-wrap on a test team and tags the Challenge Admin for review on the jira

   1. Once the Challenge Admin approves the click-wrap, ACT implements the click-wrap on the live team

7. The Challenge Admin loops in ACT upon Challenge close to modify the click-wrap if necessary. Please reference the post Challenge section of DTA or data hosting questionnaire to determine post-Challenge terms of use

   1. Please notify ACT via Jira at least 1-2 weeks prior to Challenge close-out

ACT Instructions: Setting Up Click-Wraps for Challenges

*Before starting this process, ensure a MOU/DTA and Challenge Terms of Use have been fully executed. Challenge registration should always be set up in a staging site and verified by the Challenge administrator before being applied to a live Challenge site.

1. The Challenge Administrator creates a Sign-up Team during setup (see challenge setup wiki). They also add the registration button to the Challenge staging site.

2. The Challenge Administrator sends the Governance person working on the challenge the Team ID and grants them access to the Challenge Staging site.

3. The governance person goes to the Team page.

4. On the team page click Tools->Manage Access Requirements

5. Create a new Click Wrap (Terms of Use) Access Requirement. The first Access Requirement is usually the DREAM Rules. For the general DREAM Challenge Rules, use the copy and paste the markdown from DREAM Challenge Rules subpage. 

   1. Note: first verify that the Challenge project is in fact a DREAM challenge

6. Add the clickwrap version of the terms of use agreed upon by the collaborators as part of the DUA/MOU as the second clickwrap.

   1. The clickwrap often links out to the full conditions of use, which Governance should add to the Challenge wiki staging site page

7. Ask the Challenge Administrator and one other person associated with the Challenge (possibly Julie) to verify this is correct.

8. Add the full terms of use to the Resources area of the Challenge.

9. Add the agreed upon terms of use along with the Team ID and a link to the staging site to the Conditions for Use Synapse page.

10. Ensure that the registration button on the Challenge wiki page contains the correct team ID in the wiki markdown (the Challenge scientist should set this up). As long as the Challenge registration button is linked to the team that you added the click-wrap to, the click-wrap terms will appear when users register for the Challenge.

Termination of a Challenge Project 

Often, Challenges have post-Challenge terms of use that are different from the terms of use during the Challenge project. For example, data may be released with no restrictions after the Challenge, or data may have an embargo.

If there is a post-Challenge embargo:

When the Challenge closes, ACT may need to close out the click-wrap since people who were granted access during the Challenge period would still have Challenge data access at this time. Reference the MOU/DTA post Challenge conditions for guidance. MOUs/DTAs are stored here.

If DTA or MOU indicates open access after the Challenge period:

If the DTA/MOU states that data should be open, ACT will likely need to remove the click-wrap, but the wiki page should probably still state terms clearly in the dataset overview. The data contributor should determine how to go about this.

• The Challenge Admin will remove the register option from the data page and from the homepage and will unshare the project with the Challenge team

• The Regulatory Governance contact will review request and following review, ACT will remove or modify the team click-wrap

  • Double check after adding/removing things that the click-wrap is fully there or fully removed. Make sure Challenge administrator double checks this too

Modifying/Closing Out Click-Wraps for Challenges

1. The Challenge Admin creates a Jira ticket under “Governance” and provides the information listed below. Please file the Jira under the component “Add, Edit, or Remove Synapse Access Restriction/Click-wrap.” The ticket should include the following information:

   1. Challenge name and a link to the project page in Synapse

   2. Team name and a link to the team space in Synapse that contains the click-wrap

   3. Proposed modification to the team click-wrap and a brief justification (i.e challenge close-out)

   4. Date that click-wrap modifications should be implemented (please file this ticket at least 5 business days before implementation date)

2. The Regulatory Governance contact and ACT align on the updated terms

3. ACT follows step 6 in the Challenge Process Overview section to update the click-wrap