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Items to consider prior to CRP.

Set customer configurable configuration items (Sandbox)

1. Volunteers | Configure

2. Devices | Configure

   1. Including

      1. download and installation of ClinSpark Agent

      2. download and install of free Zebra label designer software

      3. use of mock devices

3. Barcode Printing | Manage

   1. Either use basic templates out of the box or edit them, or design custom labels

4. Administration | Roles

   1. Accept the out-of-the-box Roles or start to customise them

5. Administration | Sites

   1. Add site details and configure accordingly

6. Administration | Medical Dictionaries

7. Administration | General Settings

   1. Authentication / Authorization

   2. Barcodes

   3. Data Collection

   4. Lab

   5. Phone Number Validation

   6. Samples

   7. Specimen Containers

   8. Volunteer Settings

8. Learn how to export the configuration report PDF

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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

Exiting Conference Room Pilot

1. This is a good time to request that the ‘Pre-PROD’ environment be created if you have not already done so

2. Start adding considered system configuration items manually to Pre-PROD

Clinic Floor Pilot

Items to consider prior to CFP.

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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

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Exiting Final Conference Room Pilot - 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

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