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Time

Subject

Attendees (SMEs)

9am-10am

General Configuration for Labs

Lab Manager

10am-11am

Device Configuration

Lab Manager

11am-12pm

Label Design

Lab Manager

1pm-4pm

PK Sample Processing: Simple Path Design

Lab Manager

Day 2

Study

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Design

Time

Subject

Attendees (SMEs)

9am-11am

Study Configuration

Study DesignererDesigner, Study Manager

11am-12pm & 1pm-4pm

Form Design

Study DesignererDesigner, Study Manager, Data Manager

...

Time

Subject

Attendees (SMEs)

9am-12pm

PK Sample Processing: Complex Path Design

Lab Manager

1pm-2pm

Packaging and Shipping of PK Samples

Lab Manager

2pm-4pm

PK Sample Workflows / How Tos

Lab Manager

Day 3

Study

...

Design

Time

Subject

Attendees (SMEs)

9am-11am

Activity Plan Design

Study DesignererDesigner, Study Manager, Data Manager

11am-12pm

Eligibility Mapping

Study DesignererDesigner, Study Manager, Data Manager, PI

1pm-4pm

Subject Progression Through a Trial

Study DesignererDesigner, Study Manager, Charge Nurse, PI

...

Time

Subject

Attendees (SMEs)

9am-12pm

PK Sample Intervals (Urine, Faeces etc.)

Lab Manager

1pm-2pm

Safety Lab Interface Configuration

Lab Manager

2pm-4pm

Safety Lab Study Configuration

Lab Manager

Day 4

Study

...

Design

Time

Subject

Attendees (SMEs)

9am-11am

Mid-Study Updates

Study DesignererDesigner, Data Manager

11am-12pm

Data Review / Monitoring / Reporting

Study DesignererDesigner, Study Manager, Charge Nurse, Monitor, Data Manager

1pm-4pm

Standard Form Design

Study DesignererDesigner

PK and Safety Labs

Time

Subject

Attendees (SMEs)

9am-12pm

Safety Lab Operations

Lab Manager

1pm-2pm

Clinic Floor Operations

Lab Manager

2pm-4pm

Build Sample Processing Pathways / Q&A

Lab Manager

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Time

Subject

Attendees (SMEs)

9am-12pm

Conduct mock study

Study DesignererDesigner, Study Manager, Charge Nurse, Data Manager, Lab Manager

1pm-2pm

Debrief / Key takeaways

Study DesignererDesigner, Study Manager, Charge Nurse, Data Manager, Lab Manager

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