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1. All SMEs will have been trained in their key and core areas of responsibility and exercised their anticipated tasks independently in the Sandbox

2. Assess out-of-the-box reports and data exports and visualisations using realistic mock data

3. SMEs may already have started sketching out the key aspects of SOPs and work instructions

4. Staff may already be working on drafting test cases based on their efforts in the Sandbox

5. Considered system configuration items are being manually copied to Pre-PROD

Study Build, Test and Release

1. Build or adapt at least the core forms needed for the study that will be used in the first pilot

2. Create the activity plans and add these to the applicable cohorts as demonstrated in training and explained in the documentation

3. Exercise exporting study designs from PROD to TEST

4. Ensure a ‘clean’ library of evaluated forms are kept and managed ready for use in formal testing and to be the basis of an approved forms library

Clinic Floor Pilot

Items to consider prior to CFP.

1. Administration | General Settings

   1. Communications

      1. Advanced System Setup

         1. Single Sign On - if applicable

         2. Verified Clinical Trials - if applicable

      2. Twilio, SendGrid

   2. ECG

      1. Dependent on use cases

   3. Lab

      1. Where applicable. The safety lab integration may be configured enough to an advanced state suitable for inclusion in later CFPs

Integrations

Integrations such as safety lab integrations, may be available for the CFP. Some custom system integrations or newly commissioned device integrations may also be available at this time. If not they need to be evaluated in work streams outside of more formal pilots.

Where applicable include:

1. Device integrations

2. Use of reporting APIs

3. Website integration

4. Use of Read Replica for custom queries, KPIs and reporting

5. SMS and email integrations

6. SSO

7. VCT

Operational

1. SMEs will be firming up key aspects of SOPs and work instructions

2. Thorough examination of out-of-the-box reports and data exports and visualisations using realistic mock data

3. Ensure that Roles are maturing and that participants conducting pilots use assigned Roles rather than running as ‘administrator'

4. Staff will be revising test cases based on their earlier pilots in the Sandbox. Some test cases will be good enough to ‘dry run’

5. Decisions on system configuration items may be being revised based on experience with earlier pilots. Update these and add new system configuration items manually to Pre-PROD

Study Build, Test and Release

1. Build or adapt a more extensive range of forms needed for executing a pilot with a complex study protocol

2. Update and finalise the ‘clean’ library of evaluated forms ready for formal testing and to be the basis of an approved forms library

Starting Validation

1. Draft SOPs are available

2. Draft training materials are available for end users

3. Test cases have been ‘dry-run’ in the Sandbox

4. In Pre-PROD

   1. Ensure system configuration items are in the intended state for production including applicable device and system integrations

   2. All user Roles are defined

   3. Optionally, upload the final ‘clean’ forms library as an ODM XML import

5. Pre-PROD is copied to make VAL

6. Validation

   1. Formal testing is conducted in VAL

   2. Formal testing is completed and approved with any consequential adjustments to configuration being made in Pre-PROD

Moving to Production

1. Final SOPs are published (some organisations allow training on pre-approved SOPs)

2. End-users complete final role-based training

3. Where applicable

   1. The pre-approved volunteer database migration from legacy system is executed at a chosen cutover date

   2. Pre-Prod is now designated PROD and is a fully ‘hardened’ environment designed to securely process participant PII and PHI

   3. A PROD ‘Test’ environment is created and made available to the customer

   4. External integrations are made live (e.g. configuration adjusted to production settings)

4. Qualified and trained end users may be provisioned to the PROD environments

Integration of parallel work streams

The following work streams may run in parallel with the conduct of pilots and will intersect depending on their maturity at any given time.

1. Volunteer database migration

2. Safety lab integrations

3. Custom system integrations

4. Custom device integrations

5. Others as defined in the onboarding project scope

Where necessary, discrete pieces of functionality, integrations etc. can be deferred and held back in order not to jeopardise the go-live of the ‘core’ project goals. These can then defined as smaller ancilliary projects which are added back into scope, off the critical path.