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.
Breaks may not be indicated but are included.
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 |