Bridge Data Change Request Process
- Dwayne Jeng (Unlicensed)
- Aaron Hayden (Unlicensed)
- Mike Kellen (Unlicensed)
Effective date: 07/16/2021
Owner: Chief Technology Officer
Available: Sage Intranet/Policies
Version | Summary |
|---|---|
6/30/2021 | Added versioning and tracking for Quality Program purposes, updated permanent group membership |
Changes to Bridge data must be controlled in order to ensure the accuracy and integrity of data that flows through Bridge to become part of a permanent record in another primary system.
Scope
This process covers changes to participant data in Bridge or in Synapse that does not go through the normal flow of data through Bridge (upload, export, etc). This includes (but is not limited to) redrives of uploads and exports and direct modifications of raw exported Synapse tables.
Out of scope
- Data that is not participant data, such as study configuration, schedules, surveys, or upload schemas.
- Data not managed by Bridge (such as derived Synapse tables and views). Changes to Synapse tables may require change management through the Synapse Data Change Request Process
- Test data which is structurally similar to participant data, but not collected in the context of an actual live research study.
Process Requirements
Requests for ad-hoc data changes start with a Jira issue ticket that serves as a record of the change and approval process. The issue ticket must be generated by the Scientific Project Lead of the relevant project who has the Investigator role. Submitting the request under the unique userid of investigator is considered documentation of the signing authority approval to make the change. When a change to Bridge data also requires a change to Synapse data derived from it, one request may be appropriate for both platforms but should also meet the change control requirements for both.
The issue ticket must include the following elements:
- A determination if the change request will have a material impact on the data set in the longer term. Changes to raw data (e.g. correcting an issue due to a bug in a study app) should be considered as having a material change, while those just affecting the timing of availability of data flow (e.g. re-driving failed exports) do not.
- If a material impact is determined, changes to acquired raw data must be approved by the Scientific Project Lead for all affected projects. If the project is a Sage-led project, this is the Investigator, or project manager designed by the Investigator. If the project has an external Principal Investigator, this is the Project Lead designated by Sage management. In the latter case, the Project Lead is responsible for coordinating with any external study stakeholders as needed.
- In all cases, the change request must be formally documented and tracked as an issue in Jira to create an audit-able trail of the work to be done.
- A description of who is performing the data change and the specifics of what the change entails. This should be detailed enough so that someone looking at the data after the fact can determine how the data was changed.
- Approval from the Director of Engineering or Chief Technology Officer must also included in the issue. This is to ensure that no administrative user has unilateral power over participant data, and that we have an audit-able record of following this procedure.
- Synapse tables derived from the Bridge data should not noted in cases where a Synapse change request will accompany .
Managing Synapse Permissions
All Bridge team members (server and client) are included in the BridgeStaff group (https://www.synapse.org/#!Team:3388391). This group has permissions to read and download all Bridge data in Synapse.
The BridgeAdmin group (https://www.synapse.org/#!Team:3388392) has admin permissions to all Bridge data, including write permissions. Only members of IT Operations, Directors of Engineering, and/or Chief Technology Officer will be in this group at all times. In order to make a data change in Synapse, the investigator requesting the change will need to follow the process documented above. Then, the Bridge admin will add that staff member to the BridgeAdmin group to perform the change, and once the change is completed, the Bridge admin will remove them from the BridgeAdmin group.