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Scope Review
In advance of the Kick Off Meeting, two levels of scope review occur. First, the Medable implementation team meets internally to review the study design and scope. Next, the assigned SM will meet with the Partner to ensure that both teams are aligned on the Statement of Work, that both parties are aligned on the customizations required (if applicable), and that both teams are aligned on the escalation pathway for the study, build timelines. The SM also drives a feasibility and risk assessment with the technical teams.
Kick off Meeting
Once the project scope and the Statement of Work (SOW) have been finalized, the study is handed off to the SM, who schedules a kick off and orientation meeting with the partner to confirm the project scope and requirements. The Kick Off Meeting represents the start of the implementation timeline, and should occur within one to two weeks after the execution of the Contract/SOW. The KOM will be scheduled by the assigned SM following full execution of the Contract/SOW or a Work-at-Risk agreement if applicable. Any partner-specific standards for the KOM (standard slide deck, etc) are noted in the Appendix.
Topics discussed
1
Overview of Medable roles
2
Review of KOM Slides
3
Partner provides overview of Protocol
4
Review of study documentation
5
Review of study scope
6
Review of draft PDS if possible
7
Country and site submission timelines
8
Country FPI/FPV dates
9
Data Transfer Agreement template plan
10
Workflow review and requirements gathering
11
Project Management governance
12
Plan for recurring meetings and touchpoints
13
Overview of Study Build process
14
Submission requirements
15
Any other business
Design Planning
How It Works
During the study design phase, the SM schedules calls with the Partner to determine the parameters of the workflow and the scope that must be detailed on the Project Design Specification Template (PDS) document. The eConsent Requirements Specification template is used when gathering documenting requirements for eConsent platform.
During the design calls:
- The SM reviews the solution design based on the study protocol and any other study requirements.
- The SM provides PDS document and a protocol-fitting digital recommendation.
- The SM analyzes the technical requirements and share any system constraints.
- The SM keeps track of the timelines and any potential RAID Log items.
Note: *Working from a draft protocol provides risks for design change, timelines, and additional costs. The Partner will be informed at KOM and/or in advance, of the risks associated working from a draft protocol and a risk assessment must be agreed between both parties.
The PDS contains:
1
Workflow diagram
2
Overview of functionality
3
Details on questionnaires
4
Review of study specific customizations
5
Notifications and reports
6
Additional information
Medable will provide a mockup of an app store icon based on the Partner's company logo. The Partner must provide:
- Name of company
- Company website
- Study name and application name (e.g: Site App/Patient App)
- Vector logo (.SVG, .AI, .EPS)
- Study name/number
- Privacy Policy
During the design phase, the IM facilitates a technical feasibility review process with the study build team to assess and document any technical risks and/or scope creep.
The PDS v1.0 is approved and signed by both parties via Docusign. PDS v1.0 sign-off occurs approximately 2 weeks after KOM and is mandatory for the Build step to begin. Signing the PDS v1.0 triggers the Design Freeze and allows the configuration and customization work to begin. Implementing a design freeze ensures Medable has ample time and stability to build and test a solution that conforms to design requirements. Following Design Freeze, any requested change is considered out of scope due to rework that will be required to implement. The study design is made according to the parameters already specified in the SOW and new requests must be reevaluated through a risk assessment, cost, timeline, change order, and feasibility plan before any commitment is made. Any study design changes needed after PDS v1.0 will require resubmission to Institutional of Review Boards/Ethic Committees (IRB/EC).