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Introduction

We are including below a typical timetable for a ClinSpark onsite ‘Bootcamp’ of five days. This is normally delivered by two SMEs and is supported by the assigned Project Manager and/or other specialists / consultants.

Customers are expected to provide meeting rooms to support two parallel work streams.

Scope and timings will be adjusted per customer as required.

Lunch breaks are nominally scheduled from 12.00-13:00 each day, but may be adjusted ad hoc depending on the pace of progress and at the discretion of the trainers. There is also a ‘buffer’ at the end of the day (16:00-17:00) in case sessions run long. We hope not to have to use this buffer routinely, as whole day training sessions are hard on both trainers and students!

System Administrators and System Owners are not specifically scheduled but are advised to attend applicable sessions.

Day 1

Volunteer Recruitment

Time

Subject

Attendees (SMEs)

9am-12pm

Volunteer Management

Volunteer Recruitment, Study Design

1pm-4pm

Subject Recruitment

Volunteer Recruitment, Study Design

Labs and Devices

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 Design

Time

Subject

Attendees (SMEs)

9am-11am

Study Configuration

Study Designer, Study Manager

11am-12pm & 1pm-4pm

Form Design

Study Designer, Study Manager, Data Manager

PK Labs

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 Designer, Study Manager, Data Manager

11am-12pm

Eligibility Mapping

Study Designer, Study Manager, Data Manager, PI

1pm-4pm

Subject Progression Through a Trial

Study Designer, Study Manager, Charge Nurse, PI

PK and Safety Labs

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 Designer, Data Manager

11am-12pm

Data Review / Monitoring / Reporting

Study Designer, Study Manager, Charge Nurse, Monitor, Data Manager

1pm-4pm

Standard Form Design

Study Designer

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

Day 5

Mock Study

Time

Subject

Attendees (SMEs)

9am-12pm

Conduct mock study

Study Designer, Study Manager, Charge Nurse, Data Manager, Lab Manager

1pm-2pm

Debrief / Key takeaways

Study Designer, Study Manager, Charge Nurse, Data Manager, Lab Manager

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