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1
Country & Site Selection – Wireframes IT Clinical Development andIT Human Factors / UX Design February, 2014
2
Overview Wireframes – For Reference Only (no steps or processes are shown)
Country Allocation
Identify Sites
Pre-Qualification Analysis
Site Scorecard
Final Site Selection
Strategy Components
Country Strategy
Site Strategy
Protocol-Specific Site Req.
Pre-Qualification Analysis
Site Qualification Analysis
CSS Wireframes – Application Architecture for Reference Only
IT Clinical Development and IT Human Factors / UX Design – February, 2014
3
Home
Country & Site Selection
+ New
Progress
Project Setup
Project Analysis Information
Create Project Checklist
PAREXELWelcome Christopher CFL Smith | Logout
Note: See next page
for UX comments.
!
Choose Window …
Country Allocation
Identify Sites
Pre-Qualification Analysis
Site Scorecard
Final Site Selection
Strategy Components
Country Strategy
Site Strategy
Protocol-Specific Site Req.
Pre-Qualification Analysis
Site Qualification Analysis
CSS Wireframes – Application Architecture for Reference Only
IT Clinical Development and IT Human Factors / UX Design – February, 2014
4
Home
Country & Site Selection
+ New
Progress
Project Setup
Project Analysis Information
Create Project Checklist
PAREXELWelcome Christopher CFL Smith | Logout
@DEV: The green “Project Setup” bar title and the light green background indicate where the user is currently working within a project’s workflow. The check mark indicates a completed sub-step.
@DEV: The grey “Strategy Components” bar title and the white background indicate “to be completed” portions of a project’s workflow.
@DEV: More grey topic titles and white backgrounds that indicate “to be completed” portions of a project’s workflow.
@DEV: This is just an overview Wireframe as it does not show a specific process, step or function.
!
@DEV: Left-side window shade. This should open to a minimum pixel width (TBD).
@DEV: The right-side window shade is NOT needed for all processes / steps. This should open to a minimum pixel width (TBD).
Choose Window …
This vertical window shade is NOT needed for all processes / steps.
5
CSS Wireframes – Reference Only
IT Clinical Development and IT Human Factors / UX Design – February, 2014
Home
Country & Site Selection
+ 123456
PAREXELWelcome Christopher CFL Smith | Logout
Choose Window …
Choose Action … Choose View … – +Countries Recommended: 19
Countries Available: 30
Region
All
Country
All
Pop. Size (Mlns)All
Final Overall ScoreAll
SystemRecomm.All
Least ScoredCriteria
All
Max. SitesRecomm.All
Sponsor Sugg. Countries
All
Asia
Asia
Europe
Europe
Latin Am.
Latin Am.
North Am.
North Am.
China
India
Belgium
Germany
Belize
Brazil
Canada
USA
1,300
1,050
55
95
17
42
123
370
78
92
15
87
7
12
57
61
Alpha
Beta
Gamma
Epsilon
Psi
Sigma
Tau
Omega
123
137
22
121
10
16
73
76
@DEV: This column was left blank to show how a user would manually enter data in a later step / screen.
Map – World – +Export Visualization
Note: See next page
for UX comments.
6
CSS Wireframes – Reference Only
IT Clinical Development and IT Human Factors / UX Design – February, 2014
Home
Country & Site Selection
+ 123456
PAREXELWelcome Christopher CFL Smith | Logout
@DEV: See next page for the “Scenarios” and “Messages” windows.
Choose Window …
Choose Action … Choose View … – +Countries Recommended: 19
Countries Available: 30
Region
All
Country
All
Pop. Size (Mlns)All
Final Overall ScoreAll
SystemRecomm.All
Least ScoredCriteria
All
Max. SitesRecomm.All
Sponsor Sugg. Countries
All
Asia
Asia
Europe
Europe
Latin Am.
Latin Am.
North Am.
North Am.
China
India
Belgium
Germany
Belize
Brazil
Canada
USA
1,300
1,050
55
95
17
42
123
370
78
92
15
87
7
12
57
61
Alpha
Beta
Gamma
Epsilon
Psi
Sigma
Tau
Omega
123
137
22
121
10
16
73
76
@DEV: This column was left blank to show how a user would manually enter data in a later step / screen.
@DEV: Non-SpotFire DIV.
@DEV: SpotFire DIV.
@DEV: This is just an overview Wireframe as it does not show a specific process, step or function.
@DEV: Non-SpotFire DIV.
@DEV: SpotFire DIV.
Map – World – +Export Visualization
– +Scenarios
+ 1 Pre x 3 BDM x 2 PRP3 x
7
CSS Wireframes – Reference Only
IT Clinical Development and IT Human Factors / UX Design – February, 2014
Home
Country & Site Selection
+ 123456
PAREXELWelcome Christopher CFL Smith | Logout
Choose Window …
Choose Action … Choose View … – +Countries Recommended: 19
Countries Available: 30
Region
All
Country
All
Pop. Size (Mlns)All
Final Overall ScoreAll
SystemRecomm.All
Least ScoredCriteria
All
Max. SitesRecomm.All
Sponsor Sugg. Countries
All
Asia
Asia
Europe
Europe
Latin Am.
Latin Am.
North Am.
North Am.
China
India
Belgium
Germany
Belize
Brazil
Canada
USA
1,300
1,050
55
95
17
42
123
370
78
92
15
87
7
12
57
61
Alpha
Beta
Gamma
Epsilon
Psi
Sigma
Tau
Omega
123
137
22
121
10
16
73
76
@DEV: This column was left blank to show how a user would manually enter data in a later step / screen.
Map – World – +Export Visualization
Scenario Name
Pre Award
BDM (Optimal Scenario)
Proposal (Post-Consensus Mtg.)
Sites for this Version
730 of 1,000
– +Messages
CountryAll
CountryScoreAll
Number of SitesAll
LoremIpsum
All
China
India
France
Germany
Spain
Bolivia
Mexico
Canada
100 – 300
100 – 200
150 – 300
200 – 500
250 – 500
150 – 250
80 – 150
350 – 500
Alpha
Beta
Gamma
Epsilon
Psi
Tau
Sigma
Omicron
Save Lock Scenario Select as Final
s
s
s
s
78
92
15
87
7
12
57
61
Choose Name …
Export Scenario
Note: See next page
for UX comments.
– +Scenarios Export Scenario
+ 1 Pre x 3 BDM x 2 PRP3 x
8
CSS Wireframes – Reference Only
IT Clinical Development and IT Human Factors / UX Design – February, 2014
Home
Country & Site Selection
+ 123456
PAREXELWelcome Christopher CFL Smith | Logout
Choose Window …
Choose Action … Choose View … – +Countries Recommended: 19
Countries Available: 30
Region
All
Country
All
Pop. Size (Mlns)All
Final Overall ScoreAll
SystemRecomm.All
Least ScoredCriteria
All
Max. SitesRecomm.All
Sponsor Sugg. Countries
All
Asia
Asia
Europe
Europe
Latin Am.
Latin Am.
North Am.
North Am.
China
India
Belgium
Germany
Belize
Brazil
Canada
USA
1,300
1,050
55
95
17
42
123
370
78
92
15
87
7
12
57
61
Alpha
Beta
Gamma
Epsilon
Psi
Sigma
Tau
Omega
123
137
22
121
10
16
73
76
@DEV: This column was left blank to show how a user would manually enter data in a later step / screen.
Map – World – +Export Visualization
Scenario Name
Pre Award
BDM (Optimal Scenario)
Proposal (Post-Consensus Mtg.)
Sites for this Version
730 of 1,000
– +Messages
CountryAll
CountryScoreAll
Number of SitesAll
LoremIpsum
All
China
India
France
Germany
Spain
Bolivia
Mexico
Canada
100 – 300
100 – 200
150 – 300
200 – 500
250 – 500
150 – 250
80 – 150
350 – 500
Alpha
Beta
Gamma
Epsilon
Psi
Tau
Sigma
Omicron
Save Lock Scenario Select as Final
s
s
s
s
@DEV: Use browser double arrows if the number of tabs used would exceed the allowable visual space.
78
92
15
87
7
12
57
61
Choose Name …
Pre Award BDM (Optimal Scenario) Proposal (Post-Consensus Mtg.)
9
Wireframes – Create Country Scenarios (with a few introductory screens)
10
CSS Wireframes – Create Country Scenario
IT Clinical Development and IT Human Factors / UX Design – February, 2014
Home
Country & Site Selection
+
PAREXELWelcome Christopher CFL Smith | Logout
Create New Project Analysis
Search CancelEnter Opportunity # … Enter Project #Or
11
CSS Wireframes – Create Country Scenario
IT Clinical Development and IT Human Factors / UX Design – February, 2014
Home
Country & Site Selection
+
PAREXELWelcome Christopher CFL Smith | Logout
Create New Project Analysis
Opportunity # Project # Sponsor Date
452123
452357
452456
452987
456789
357681
894523
459786
ZDC
PLR
MRT
LKJ
12-Dec-2012
05-May-2013
19-Jun-2013
05-Jul-2013
Analysis Indication
Pre Award
Post Award
Post Award
Pre Award
Oncology
Arthritis
Immunology
Respiratory
Enter Opportunity # …
New
Search Cancel789Or
12
CSS Wireframes – Create Country Scenario
IT Clinical Development and IT Human Factors / UX Design – February, 2014
Home
Country & Site Selection
+
PAREXELWelcome Christopher CFL Smith | Logout
Create New Project Analysis
Create Analysis Cancel Analysis
Enter Opportunity # … 456789
New
Or
Source Information
Project #
Opportunity #
Sponsor Name
Therapeutic Area
Indication
Drug Product Name
Phase
Analysis Type
Analysis Type
Analysis Type
Read Only
Read Only
Read Only
Read Only
Read Only
Read Only
Read Only
Read OnlyChoose Award Type …
For Rescue Only …
For Rescue Only …
Note: See next page
for UX comments.
13
CSS Wireframes – Create Country Scenario
IT Clinical Development and IT Human Factors / UX Design – February, 2014
Home
Country & Site Selection
+
PAREXELWelcome Christopher CFL Smith | Logout
Create New Project Analysis
Create Analysis Cancel Analysis
Enter Opportunity # … 456789
New
1
Or
Source Information
Project #
Opportunity #
Sponsor Name
Therapeutic Area
Indication
Drug Product Name
Phase
Analysis Type
Analysis Type
Analysis Type
Read Only
Read Only
Read Only
Read Only
Read Only
Read Only
Read Only
Read OnlyChoose Award Type …
For Rescue Only …
For Rescue Only …
Pre-Award
Post Award
Rescue
Requires Additional Countries
Requires Additional Sites
Protocol Change
Target Patients Over Randomized Patients
Low Enrollment Rate
Ethics Approval Challenges
2
3
@DEV: Steps 2 and 3 are available only if Step 1 is set to “Rescue”.
4
@DEV: The “NEW” tab title changes to 456789.
Country Allocation
Identify Sites
Pre-Qualification Analysis
Site Scorecard
Final Site Selection
Strategy Components
Country Strategy
Site Strategy
Protocol-Specific Site Req.
Pre-Qualification Analysis
Site Qualification Analysis
Progress
Project Setup
Project Analysis Information
Create Project Checklist
14
CSS Wireframes – Create Country Scenario
IT Clinical Development and IT Human Factors / UX Design – February, 2014
Home
Country & Site Selection
+
PAREXELWelcome Christopher CFL Smith | Logout
Project Analysis Information
Next Cancel Analysis
456789
Therapeutic Area
Indication
Study Design
Phase
Age (Minimum)
Age (Maximum)
Drug Product Name
Oncology
Stage 1 Carcinoma
Alpha Centauri
Phase III
Drug Name
Choose Age (Min.) …
Analysis Number
Analysis Type
Sponsor
Partnership
456789
Pre-Award
YoYoDyne Pharmaceutical
Select Partner Name …
DesignateDocument Link
Analysis Team Designate
Project Information Country and Site Expectations
Choose Age (Max.) …
Pre-Award
Expected # of Countries
Expected # of Sites
Expected # of Patients
Expected Enrollment Time
Planned Actual
Read OnlyEnter # …
Enter # …
Enter # …
Enter # …
Read Only
Read Only
Read Only
Save
x
Choose Window …
Note: See next page
for UX comments.
Country Allocation
Identify Sites
Pre-Qualification Analysis
Site Scorecard
Final Site Selection
Strategy Components
Country Strategy
Site Strategy
Protocol-Specific Site Req.
Pre-Qualification Analysis
Site Qualification Analysis
Progress
Project Setup
Project Analysis Information
Create Project Checklist
15
CSS Wireframes – Create Country Scenario
IT Clinical Development and IT Human Factors / UX Design – February, 2014
Home
Country & Site Selection
+
PAREXELWelcome Christopher CFL Smith | Logout
Project Analysis Information
Next Cancel Analysis
456789
Therapeutic Area
Indication
Study Design
Phase
Age (Minimum)
Age (Maximum)
Drug Product Name
Oncology
Stage 1 Carcinoma
Alpha Centauri
Phase III
Drug Name
Choose Age (Min.) …
Analysis Number
Analysis Type
Sponsor
Partnership
456789
Pre-Award
YoYoDyne Pharmaceutical
Select Partner Name …
DesignateDocument Link
Analysis Team Designate
Project Information Country and Site Expectations
Choose Age (Max.) …
Pre-Award
Expected # of Countries
Expected # of Sites
Expected # of Patients
Expected Enrollment Time
Planned Actual
Read OnlyEnter # …
Enter # …
Enter # …
Enter # …
Read Only
Read Only
Read Only
1
Save
@DEV: “Designate” steps 1 and 2 are covered in the high-res Wireframes and will not be covered here to save time and space.
2
x
Choose Window …
@DEV: See the next screen / Wireframe for the Post Award version.
Country Allocation
Identify Sites
Pre-Qualification Analysis
Site Scorecard
Final Site Selection
Strategy Components
Country Strategy
Site Strategy
Protocol-Specific Site Req.
Pre-Qualification Analysis
Site Qualification Analysis
Progress
Project Setup
Project Analysis Information
Create Project Checklist
16
CSS Wireframes – Create Country Scenario
IT Clinical Development and IT Human Factors / UX Design – February, 2014
Home
Country & Site Selection
+
PAREXELWelcome Christopher CFL Smith | Logout
Project Analysis Information
Next Cancel Analysis
456789
Therapeutic Area
Indication
Study Design
Phase
Age (Minimum)
Age (Maximum)
Drug Product Name
Oncology
Stage 1 Carcinoma
Alpha Centauri
Phase III
Drug Name
Choose Age (Min.) …
Analysis Number
Analysis Type
Sponsor
456789
Post Award
YoYoDyne Pharmaceutical
DesignateDocument Link
Team Members Designate
Project Information Country and Site Expectations
Choose Age (Max.) …
Post Award
Expected # of Countries
Expected # of Sites
Expected # of Patients
Expected Enrollment Time
Planned Actual
Read OnlyEnter # …
Enter # …
Enter # …
Enter # …
Read Only
Read Only
Read Only
Save
x
Choose Window …
Note: See next page
for UX comments.
Country Allocation
Identify Sites
Pre-Qualification Analysis
Site Scorecard
Final Site Selection
Strategy Components
Country Strategy
Site Strategy
Protocol-Specific Site Req.
Pre-Qualification Analysis
Site Qualification Analysis
Progress
Project Setup
Project Analysis Information
Create Project Checklist
17
CSS Wireframes – Create Country Scenario
IT Clinical Development and IT Human Factors / UX Design – February, 2014
Home
Country & Site Selection
+
PAREXELWelcome Christopher CFL Smith | Logout
Project Analysis Information
Next Cancel Analysis
456789
Therapeutic Area
Indication
Study Design
Phase
Age (Minimum)
Age (Maximum)
Drug Product Name
Oncology
Stage 1 Carcinoma
Alpha Centauri
Phase III
Drug Name
Choose Age (Min.) …
Analysis Number
Analysis Type
Sponsor
456789
Post Award
YoYoDyne Pharmaceutical
DesignateDocument Link
Team Members Designate
Project Information Country and Site Expectations
Choose Age (Max.) …
Post Award
Expected # of Countries
Expected # of Sites
Expected # of Patients
Expected Enrollment Time
Planned Actual
Read OnlyEnter # …
Enter # …
Enter # …
Enter # …
Read Only
Read Only
Read Only
Save
x
Choose Window …
@DEV: The various Strategy Components (consisting of the PSSR, Country Strategy, Site Strategy, PQA and SQA sub tabs) are covered in the high-res Wireframes and will not be covered here to save time and space.
Messages
18
Country & Site Selection PAREXELWelcome Christopher CFL Smith | Logout
Choose Window …
Choose Action … Choose View …Countries Recommended: 19
Countries Available: 30
Final Overall ScoreAll
SystemRecomm.All
Least ScoredCriteria
All
Max. SitesRecomm.All
Sponsor Sugg. Countries
All
Map – WorldExport Visualization
Scenarios
+
Export Scenario
Save Lock Scenario Select as Final
CSS Wireframes – Create Country Scenario [Confluence Step 1]
IT Clinical Development and IT Human Factors / UX Design – February, 2014
78
92
15
87
7
12
57
61
Alpha
Beta
Gamma
Epsilon
Psi
Sigma
Tau
Omega
123
137
22
121
10
16
73
76
Region
All
Country
All
Pop. Size (Mlns)All
Asia
Asia
Europe
Europe
Latin Am.
Latin Am.
North Am.
North Am.
China
India
Belgium
Germany
Belize
Brazil
Canada
USA
1,300
1,050
55
95
17
42
123
370
s
s
s
@DEV: Pressing on the [+] green mini tab, starts a new scenario. (See next screen.)
Home + 456789 x
Note: See next page
for UX comments.
Messages
19
Country & Site Selection PAREXELWelcome Christopher CFL Smith | Logout
Choose Window …
Choose Action … Choose View …Countries Recommended: 19
Countries Available: 30
Final Overall ScoreAll
SystemRecomm.All
Least ScoredCriteria
All
Max. SitesRecomm.All
Sponsor Sugg. Countries
All
Map – WorldExport Visualization
Scenarios
+
Export Scenario
Save Lock Scenario Select as Final
CSS Wireframes – Create Country Scenario [Confluence Step 1]
IT Clinical Development and IT Human Factors / UX Design – February, 2014
1
78
92
15
87
7
12
57
61
Alpha
Beta
Gamma
Epsilon
Psi
Sigma
Tau
Omega
123
137
22
121
10
16
73
76
@DEV: This column was left blank to show how a user would manually enter data in a later step / screen.
@DEV: Move the “Export Visualization” link to the “Choose Action” pull-down menu.
@DEV: Countries are now color-coded directly, instead of using these colored diamonds.
As I can’t manipulate the world map illustration in PowerPoint, I’ll leave the colored diamonds as they are now.
@DEV: “Choose View” pull-down menu values: All (default); Clinical Rating; Medical Rating; Operational Rating. (Others TBD via @BA Jasmine.)
@DEV: These 2 columns are now merged and the color fills the field.
See next screen.
Region
All
Country
All
Pop. Size (Mlns)All
Asia
Asia
Europe
Europe
Latin Am.
Latin Am.
North Am.
North Am.
China
India
Belgium
Germany
Belize
Brazil
Canada
USA
1,300
1,050
55
95
17
42
123
370
s
s
s
@DEV: The “S” sub-contractor icon needs to be in both the Spotfire and non-Spotfire (“Scenarios”) sections. See next screen.
@DEV: Pressing on the [+] green mini tab, starts a new scenario. (See next screen.)
Home + 456789 x
20
Country & Site Selection PAREXELWelcome Christopher CFL Smith | Logout
Choose Window …
Choose Action … Choose View …Countries Recommended: 19
Countries Available: 30
Sponsor Sugg. Countries
All
Map – World
Scenarios
+
Sites for this Version
450 of 1,000
Messages
CountryAll
CountryScoreAll
Number of SitesAll
LoremIpsum
All
Export Scenario
Save Lock Scenario
CSS Wireframes – Create Country Scenario [Confluence Step 1]
IT Clinical Development and IT Human Factors / UX Design – February, 2014
100 – 300
100 – 200
200 – 500
250 – 500
80 – 150
350 – 500
Alpha
Beta
Epsilon
Psi
Sigma
Omicron
s
s
s
Least ScoredCriteria
All
Alpha
Beta
Gamma
Epsilon
Psi
Sigma
Tau
Omega
Max. SitesRecomm.All
123
137
22
121
10
16
73
76
China
India
Germany
Belize
Canada
USA
Region
All
Asia
Asia
Europe
Europe
Latin Am.
Latin Am.
North Am.
North Am.
Country
All
China
India
Belgium
Germany
Belize
Brazil
Canada
USA
Pop. Size (Mlns)All
1,300
1,050
55
95
17
42
123
370
s
s
s
Final Overall ScoreAll
78
92
15
87
7
12
57
61
78
92
87
91
78
37
Scenario Name
Choose Name …
Select as Final
Home + 456789 x
Note: See next page
for UX comments.
21
Country & Site Selection PAREXELWelcome Christopher CFL Smith | Logout
Choose Window …
Choose Action … Choose View …Countries Recommended: 19
Countries Available: 30
Sponsor Sugg. Countries
All
Map – World
Scenarios
+
Sites for this Version
450 of 1,000
Messages
CountryAll
CountryScoreAll
Number of SitesAll
LoremIpsum
All
Export Scenario
Save Lock Scenario
CSS Wireframes – Create Country Scenario [Confluence Step 1]
IT Clinical Development and IT Human Factors / UX Design – February, 2014
100 – 300
100 – 200
200 – 500
250 – 500
80 – 150
350 – 500
Alpha
Beta
Epsilon
Psi
Sigma
Omicron
s
s
s
1
Least ScoredCriteria
All
Alpha
Beta
Gamma
Epsilon
Psi
Sigma
Tau
Omega
Max. SitesRecomm.All
123
137
22
121
10
16
73
76
2
4
5
China
India
Germany
Belize
Canada
USA
1
Region
All
Asia
Asia
Europe
Europe
Latin Am.
Latin Am.
North Am.
North Am.
Country
All
China
India
Belgium
Germany
Belize
Brazil
Canada
USA
Pop. Size (Mlns)All
1,300
1,050
55
95
17
42
123
370
s
s
s
Final Overall ScoreAll
78
92
15
87
7
12
57
61
78
92
87
91
78
37
Scenario Name
Choose Name …
Pre Award BDM (Optimal Scenario) Proposal (Post-Consensus Mtg.)
@DEV #3: Only sponsored-recommended countries are added by the system.
Users can add red-coded counties and a rational which we show in later steps.
3
Select as Final
Home + 456789 x
22
Country & Site Selection PAREXELWelcome Christopher CFL Smith | Logout
Choose Window …
Choose Action … Choose View …Countries Recommended: 19
Countries Available: 30
Map – World
Scenarios
+
Messages
CountryAll
CountryScoreAll
Number of SitesAll
LoremIpsum
All
Export Scenario
Save Lock Scenario
CSS Wireframes – Create Country Scenario [Confluence Step 2]
IT Clinical Development and IT Human Factors / UX Design – February, 2014
s
s
100 – 300
100 – 200
80 – 120
200 – 500
250 – 500
200 – 500
80 – 150
350 – 500
Alpha
Beta
Gamma
Epsilon
Psi
Sigma
Tau
Omega
s
China
India
Belgium
Germany
Belize
Brazil
Canada
USA
1 Prex
s
s
s
Sponsor Sugg. Countries
All
Least ScoredCriteria
All
Alpha
Beta
Gamma
Epsilon
Psi
Sigma
Tau
Omega
Max. SitesRecomm.All
123
137
22
121
10
16
73
76
Region
All
Asia
Asia
Europe
Europe
Latin Am.
Latin Am.
North Am.
North Am.
Country
All
China
India
Belgium
Germany
Belize
Brazil
Canada
USA
Pop. Size (Mlns)All
1,300
1,050
55
95
17
42
123
370
Final Overall ScoreAll
78
92
15
87
7
12
57
61
78
92
15
87
7
12
57
61
Sites for this Version
450 of 1,000
Scenario Name
Pre-Award
Select as Final
Home + 456789 x
Note: See next page
for UX comments.
23
Country & Site Selection PAREXELWelcome Christopher CFL Smith | Logout
Choose Window …
Choose Action … Choose View …Countries Recommended: 19
Countries Available: 30
Map – World
Scenarios
+
Messages
CountryAll
CountryScoreAll
Number of SitesAll
LoremIpsum
All
Export Scenario
Save Lock Scenario
CSS Wireframes – Create Country Scenario [Confluence Step 2]
IT Clinical Development and IT Human Factors / UX Design – February, 2014
s
s
@DEV #1 and 2: User selects a country with their cursor (bottom left) or clicking on country’s line (top left) selects it. Then, use the pull-down menu “Choose Action” to add the country to the scenario (below). Note: the “Site for this Version” (upper right) changes as countries are added or subtracted.
100 – 300
100 – 200
80 – 120
200 – 500
250 – 500
200 – 500
80 – 150
350 – 500
Alpha
Beta
Gamma
Epsilon
Psi
Sigma
Tau
Omega
s
China
India
Belgium
Germany
Belize
Brazil
Canada
USA
1
2
1 Prex
1
2
s
s
s
1
2
Sponsor Sugg. Countries
All
Least ScoredCriteria
All
Alpha
Beta
Gamma
Epsilon
Psi
Sigma
Tau
Omega
Max. SitesRecomm.All
123
137
22
121
10
16
73
76
Region
All
Asia
Asia
Europe
Europe
Latin Am.
Latin Am.
North Am.
North Am.
Country
All
China
India
Belgium
Germany
Belize
Brazil
Canada
USA
Pop. Size (Mlns)All
1,300
1,050
55
95
17
42
123
370
Final Overall ScoreAll
78
92
15
87
7
12
57
61
78
92
15
87
7
12
57
61
Sites for this Version
450 of 1,000
Scenario Name
Pre-Award
Select as Final
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24
Country & Site Selection PAREXELWelcome Christopher CFL Smith | Logout
Choose Window …
Choose Action … Choose View …Countries Recommended: 19
Countries Available: 30
Map – World
Scenarios
+
Messages
CountryAll
CountryScoreAll
Number of SitesAll
LoremIpsum
All
Export Scenario
Save Lock Scenario
CSS Wireframes – Create Country Scenario [Confluence Step 3]
IT Clinical Development and IT Human Factors / UX Design – February, 2014
s
s
100 – 300
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80 – 120
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350 – 500
Alpha
Beta
Gamma
Epsilon
Psi
Sigma
Tau
Omega
s
China
India
Belgium
Germany
Belize
Brazil
Canada
USA
1 Prex
s
s
s
Sponsor Sugg. Countries
All
Least ScoredCriteria
All
Alpha
Beta
Gamma
Epsilon
Psi
Sigma
Tau
Omega
Max. SitesRecomm.All
123
137
22
121
10
16
73
76
Region
All
Asia
Asia
Europe
Europe
Latin Am.
Latin Am.
North Am.
North Am.
Country
All
China
India
Belgium
Germany
Belize
Brazil
Canada
USA
Pop. Size (Mlns)All
1,300
1,050
55
95
17
42
123
370
Final Overall ScoreAll
78
92
15
87
7
12
57
61
78
92
15
87
7
12
57
61
Sites for this Version
450 of 1,000
Scenario Name
Pre-Award
Select as Final
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Note: See next page
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25
Country & Site Selection PAREXELWelcome Christopher CFL Smith | Logout
Choose Window …
Choose Action … Choose View …Countries Recommended: 19
Countries Available: 30
Map – World
Scenarios
+
Messages
CountryAll
CountryScoreAll
Number of SitesAll
LoremIpsum
All
Export Scenario
Save Lock Scenario
CSS Wireframes – Create Country Scenario [Confluence Step 3]
IT Clinical Development and IT Human Factors / UX Design – February, 2014
s
s
@DEV #1: User enters the overall approach applied to the scenario using up to 8000 characters.
(This is information is not mandatory. The user can save scenario without having to enter a rationale.)
100 – 300
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250 – 500
200 – 500
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350 – 500
Alpha
Beta
Gamma
Epsilon
Psi
Sigma
Tau
Omega
s
China
India
Belgium
Germany
Belize
Brazil
Canada
USA
1
1 Prex
s
s
s
Sponsor Sugg. Countries
All
Least ScoredCriteria
All
Alpha
Beta
Gamma
Epsilon
Psi
Sigma
Tau
Omega
Max. SitesRecomm.All
123
137
22
121
10
16
73
76
Region
All
Asia
Asia
Europe
Europe
Latin Am.
Latin Am.
North Am.
North Am.
Country
All
China
India
Belgium
Germany
Belize
Brazil
Canada
USA
Pop. Size (Mlns)All
1,300
1,050
55
95
17
42
123
370
Final Overall ScoreAll
78
92
15
87
7
12
57
61
78
92
15
87
7
12
57
61
Sites for this Version
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Scenario Name
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Home
Country & Site Selection
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PAREXELWelcome Christopher CFL Smith | Logout
CSS Wireframes – Create Country Scenario [Confluence Step 4]
IT Clinical Development and IT Human Factors / UX Design – February, 2014
@DEV: Outside CSS Process Step:
The user creates a test document and enters the countries based on the selection made in CSS.
Once completed, the test document gives the user the enrollment timelines for the study which helps
the user decide if they need to add or remove countries from the test document.
The user completes the test document.
27
Country & Site Selection PAREXELWelcome Christopher CFL Smith | Logout
Choose Window …
Choose Action … Choose View …Countries Recommended: 19
Countries Available: 30
Map – World
Scenarios
+
Messages
CountryAll
CountryScoreAll
Number of SitesAll
LoremIpsum
All
Export Scenario
Save Lock Scenario
CSS Wireframes – Create Country Scenario [Confluence Step 5]
IT Clinical Development and IT Human Factors / UX Design – February, 2014
s
s
@DEV #1: The user enters the country-wide enrollment timeline and the number of sites based on the SPARC data for each country.
The user also adjusts the countries within the scenario based on any additions or deletion made during the SPARC creation.
100 – 300
100 – 200
80 – 120
200 – 500
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80 – 150
350 – 500
Alpha
Beta
Gamma
Epsilon
Psi
Sigma
Tau
Omega
s
China
India
Belgium
Germany
Belize
Brazil
Canada
USA
1
1 Prex
s
s
s
Sponsor Sugg. Countries
All
Least ScoredCriteria
All
Alpha
Beta
Gamma
Epsilon
Psi
Sigma
Tau
Omega
Max. SitesRecomm.All
123
137
22
121
10
16
73
76
Region
All
Asia
Asia
Europe
Europe
Latin Am.
Latin Am.
North Am.
North Am.
Country
All
China
India
Belgium
Germany
Belize
Brazil
Canada
USA
Pop. Size (Mlns)All
1,300
1,050
55
95
17
42
123
370
Final Overall ScoreAll
78
92
15
87
7
12
57
61
78
92
15
87
7
12
57
61
Sites for this Version
450 of 1,000
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28
Country & Site Selection PAREXELWelcome Christopher CFL Smith | Logout
Choose Window …
Choose Action … Choose View …Countries Recommended: 19
Countries Available: 30
Map – World
Scenarios
+
Messages
CountryAll
CountryScoreAll
Number of SitesAll
LoremIpsum
All
Export Scenario
Save Lock Scenario
CSS Wireframes – Create Country Scenario [Confluence Step 6]
IT Clinical Development and IT Human Factors / UX Design – February, 2014
s
s
@DEV #1: The user saves the data within the "Scenarios" window while working parallel on the SPARC.
#2a: If the user has finalized the SPARC, then the user locks the "Scenarios" window.
#2b: Locking the scenario ensures that the scores and the recommendations captured during the creation of the scenario are not affected by the change in the country scores and recommendations made in the data table.
#2c: Locking the scenario also prompts the user to provide rationale comments for the countries used that were not recommended by the CSS platform.
100 – 300
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Alpha
Beta
Gamma
Epsilon
Psi
Sigma
Tau
Omega
s
China
India
Belgium
Germany
Belize
Brazil
Canada
USA
1
1 Prex
s
s
s
Sponsor Sugg. Countries
All
Least ScoredCriteria
All
Alpha
Beta
Gamma
Epsilon
Psi
Sigma
Tau
Omega
Max. SitesRecomm.All
123
137
22
121
10
16
73
76
Region
All
Asia
Asia
Europe
Europe
Latin Am.
Latin Am.
North Am.
North Am.
Country
All
China
India
Belgium
Germany
Belize
Brazil
Canada
USA
Pop. Size (Mlns)All
1,300
1,050
55
95
17
42
123
370
Final Overall ScoreAll
78
92
15
87
7
12
57
61
78
92
15
87
7
12
57
61
2
Sites for this Version
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29
Country & Site Selection PAREXELWelcome Christopher CFL Smith | Logout
Choose Window …
Choose Action … Choose View …Countries Recommended: 19
Countries Available: 30
Map – World
Scenarios
+
Messages
CountryAll
CountryScoreAll
Number of SitesAll
LoremIpsum
All
Export Scenario
Save Lock Scenario
CSS Wireframes – Create Country Scenario [Confluence Steps 7 and 8]
IT Clinical Development and IT Human Factors / UX Design – February, 2014
s
s
100 – 300
100 – 200
80 – 120
200 – 500
250 – 500
200 – 500
80 – 150
350 – 500
Alpha
Beta
Gamma
Epsilon
Psi
Sigma
Tau
Omega
s
China
India
Belgium
Germany
Belize
Brazil
Canada
USA
1 Prex
s
s
s
Sponsor Sugg. Countries
All
Least ScoredCriteria
All
Alpha
Beta
Gamma
Epsilon
Psi
Sigma
Tau
Omega
Max. SitesRecomm.All
123
137
22
121
10
16
73
76
Region
All
Asia
Asia
Europe
Europe
Latin Am.
Latin Am.
North Am.
North Am.
Country
All
China
India
Belgium
Germany
Belize
Brazil
Canada
USA
Pop. Size (Mlns)All
1,300
1,050
55
95
17
42
123
370
Final Overall ScoreAll
78
92
15
87
7
12
57
61
78
92
15
87
7
12
57
61
2 BDMx
3 Propx
Sites for this Version
450 of 1,000
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Note: See next page
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30
Country & Site Selection PAREXELWelcome Christopher CFL Smith | Logout
Choose Window …
Choose Action … Choose View …Countries Recommended: 19
Countries Available: 30
Map – World
Scenarios
+
Messages
CountryAll
CountryScoreAll
Number of SitesAll
LoremIpsum
All
Export Scenario
Save Lock Scenario
CSS Wireframes – Create Country Scenario [Confluence Steps 7 and 8]
IT Clinical Development and IT Human Factors / UX Design – February, 2014
s
s
@DEV Confluence Step 7 – #1: At any point during this process there could be a need to re-evaluate the strategy due to a sponsor requirement revision or additional guidance received during internal discussions.
This change in strategy, when finalized, triggers the refresh of the country score and recommendations. The system would update the country score and recommendations for the scenario that are not locked (#2 and 3).
4
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350 – 500
Alpha
Beta
Gamma
Epsilon
Psi
Sigma
Tau
Omega
s
China
India
Belgium
Germany
Belize
Brazil
Canada
USA
1 Prex
s
s
s
Sponsor Sugg. Countries
All
Least ScoredCriteria
All
Alpha
Beta
Gamma
Epsilon
Psi
Sigma
Tau
Omega
Max. SitesRecomm.All
123
137
22
121
10
16
73
76
Region
All
Asia
Asia
Europe
Europe
Latin Am.
Latin Am.
North Am.
North Am.
Country
All
China
India
Belgium
Germany
Belize
Brazil
Canada
USA
Pop. Size (Mlns)All
1,300
1,050
55
95
17
42
123
370
Final Overall ScoreAll
78
92
15
87
7
12
57
61
78
92
15
87
7
12
57
61
2 BDMx
3 Propx
32
@DEV Confluence Step 8 – #4 (creates #2 and 3): The user would create another scenario with the appropriate name and follow the process described in Confluence Steps 1, 2, 3, 4 and 5 (see previous pages).
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Country & Site Selection PAREXELWelcome Christopher CFL Smith | Logout
Choose Window …
Choose Action … Choose View …Countries Recommended: 19
Countries Available: 30
Map – World
Scenarios
+
Messages
CountryAll
CountryScoreAll
Number of SitesAll
LoremIpsum
All
Export Scenario
Save Lock Scenario
CSS Wireframes – Create Country Scenario [Confluence Step 9 (pre Pop-Up Window)]
IT Clinical Development and IT Human Factors / UX Design – February, 2014
s
s
@DEV #1: The user extracts the data from the "Scenarios" window and the data table for use with internal and external discussions and agreements.
It is critical to capture the enrollment timelines and the number of sites per country within the "Scenarios" window to ensure that the data extracted creates the required picture to support the discussion process.
The user clicks the “Export Scenario” link (at “1”) to select the scenarios (e.g., “1 Pre”, “2 BDM” and “3 Prop”) that they want to export. (See next screen for the pop-up window.)
100 – 300
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350 – 500
Alpha
Beta
Gamma
Epsilon
Psi
Sigma
Tau
Omega
s
China
India
Belgium
Germany
Belize
Brazil
Canada
USA
1
1 Prex
s
s
s
Sponsor Sugg. Countries
All
Least ScoredCriteria
All
Alpha
Beta
Gamma
Epsilon
Psi
Sigma
Tau
Omega
Max. SitesRecomm.All
123
137
22
121
10
16
73
76
Region
All
Asia
Asia
Europe
Europe
Latin Am.
Latin Am.
North Am.
North Am.
Country
All
China
India
Belgium
Germany
Belize
Brazil
Canada
USA
Pop. Size (Mlns)All
1,300
1,050
55
95
17
42
123
370
Final Overall ScoreAll
78
92
15
87
7
12
57
61
78
92
15
87
7
12
57
61
2 BDMx
3 Propx
Sites for this Version
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Select as Final
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32
Country & Site Selection PAREXELWelcome Christopher CFL Smith | Logout
Choose Window …
Choose Action … Choose View …Countries Recommended: 19
Countries Available: 30
Map – World
Scenarios
+
Messages
CountryAll
CountryScoreAll
Number of SitesAll
LoremIpsum
All
Export Scenario
Save Lock Scenario
CSS Wireframes – Create Country Scenario [Confluence Step 9 (with Pop-Up Window)]
IT Clinical Development and IT Human Factors / UX Design – February, 2014
s
s
@DEV #1: The user extracts the data from the "Scenarios" window and the data table for use with internal and external discussions and agreements.
It is critical to capture the enrollment timelines and the number of sites per country within the "Scenarios" window to ensure that the data extracted creates the required picture to support the discussion process.
The user clicks the “Export Scenario” link (at “1”) to select the scenarios (e.g., “1 Pre”, “2 BDM” and “3 Prop”) that they want to export. (See next screen for the pop-up window.
100 – 300
100 – 200
80 – 120
200 – 500
250 – 500
200 – 500
80 – 150
350 – 500
Alpha
Beta
Gamma
Epsilon
Psi
Sigma
Tau
Omega
s
China
India
Belgium
Germany
Belize
Brazil
Canada
USA
1 Prex
s
s
s
Sponsor Sugg. Countries
All
Least ScoredCriteria
All
Alpha
Beta
Gamma
Epsilon
Psi
Sigma
Tau
Omega
Max. SitesRecomm.All
123
137
22
121
10
16
73
76
Region
All
Asia
Asia
Europe
Europe
Latin Am.
Latin Am.
North Am.
North Am.
Country
All
China
India
Belgium
Germany
Belize
Brazil
Canada
USA
Pop. Size (Mlns)All
1,300
1,050
55
95
17
42
123
370
Final Overall ScoreAll
78
92
15
87
7
12
57
61
78
92
15
87
7
12
57
61
2 BDMx
3 Propx
Sites for this Version
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x
Export Scenarios
1 PRE
2 BDM
3 Proposal
Save Cancel
!!
33
Country & Site Selection PAREXELWelcome Christopher CFL Smith | Logout
Choose Window …
Choose Action … Choose View …Countries Recommended: 19
Countries Available: 30
Map – World
Scenarios
+
Messages
CountryAll
CountryScoreAll
Number of SitesAll
LoremIpsum
All
Export Scenario
Save Lock Scenario
CSS Wireframes – Create Country Scenario [Confluence Step 10a]
IT Clinical Development and IT Human Factors / UX Design – February, 2014
s
s
@DEV #1: The user edits one of the scenarios during a post-consensus CSS meeting and adds or removes countries as required and finalizes the scenario. This would be renamed as “BDM (Optimal Scenario)” by the system. (See next screen.)
100 – 300
100 – 200
80 – 120
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250 – 500
200 – 500
80 – 150
350 – 500
Alpha
Beta
Gamma
Epsilon
Psi
Sigma
Tau
Omega
s
China
India
Belgium
Germany
Belize
Brazil
Canada
USA
1 Prex
s
s
s
Sponsor Sugg. Countries
All
Least ScoredCriteria
All
Alpha
Beta
Gamma
Epsilon
Psi
Sigma
Tau
Omega
Max. SitesRecomm.All
123
137
22
121
10
16
73
76
Region
All
Asia
Asia
Europe
Europe
Latin Am.
Latin Am.
North Am.
North Am.
Country
All
China
India
Belgium
Germany
Belize
Brazil
Canada
USA
Pop. Size (Mlns)All
1,300
1,050
55
95
17
42
123
370
Final Overall ScoreAll
78
92
15
87
7
12
57
61
78
92
15
87
7
12
57
61
2 BDMx
3 Propx
1
Sites for this Version
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Select as Final
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34
Country & Site Selection PAREXELWelcome Christopher CFL Smith | Logout
Choose Window …
Choose Action … Choose View …Countries Recommended: 19
Countries Available: 30
Map – World
Scenarios
+
Messages
CountryAll
CountryScoreAll
Number of SitesAll
LoremIpsum
All
Export Scenario
Save Lock Scenario
CSS Wireframes – Create Country Scenario [Confluence Step 10b]
IT Clinical Development and IT Human Factors / UX Design – February, 2014
s
s
@DEV #1: The user edits one of the scenarios during a post-consensus CSS meeting and adds or removes countries as required and finalizes the scenario. This would be renamed as “BDM (Optimal Scenario)” by the system.
100 – 300
100 – 200
80 – 120
200 – 500
250 – 500
200 – 500
80 – 150
350 – 500
Alpha
Beta
Gamma
Epsilon
Psi
Sigma
Tau
Omega
s
China
India
Belgium
Germany
Belize
Brazil
Canada
USA
1 Prex
s
s
s
Sponsor Sugg. Countries
All
Least ScoredCriteria
All
Alpha
Beta
Gamma
Epsilon
Psi
Sigma
Tau
Omega
Max. SitesRecomm.All
123
137
22
121
10
16
73
76
Region
All
Asia
Asia
Europe
Europe
Latin Am.
Latin Am.
North Am.
North Am.
Country
All
China
India
Belgium
Germany
Belize
Brazil
Canada
USA
Pop. Size (Mlns)All
1,300
1,050
55
95
17
42
123
370
Final Overall ScoreAll
78
92
15
87
7
12
57
61
78
92
15
87
7
12
57
61
2 BDMx
3 BDMx
1
Sites for this Version
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CSS Wireframes – Blank Section Break
IT Clinical Development and IT Human Factors / UX Design – February, 2014
@DEV: This is a blank section break.
There’s nothing to see here. Please move along. ☺
36
CSS Wireframes – CSS-162 Project Library [based on My Projects]
IT Clinical Development and IT Human Factors / UX Design – February, 2014
@DEV: For Jira item CSS-162 “Project Library”, please see p47 of “Country-Site-Selector--2014-0113--v17b.pdf” (or a later version/date of that file) located in PMED.
37
Country & Site Selection PAREXELWelcome Christopher CFL Smith | Logout
Choose Window …
Choose Action … Choose View … – +Countries Recommended: 19
Countries Available: 30
Region
All
Country
All
Pop. Size (Mlns)All
Final Overall ScoreAll
SystemRecomm.All
Least ScoredCriteria
All
Max. SitesRecomm.All
Sponsor Sugg. Countries
All
Asia
Asia
Europe
Europe
Latin Am.
Latin Am.
North Am.
North Am.
China
India
Belgium
Germany
Belize
Brazil
Canada
USA
1,300
1,050
55
95
17
42
123
370
78
92
15
87
7
12
57
61
Alpha
Beta
Gamma
Epsilon
Psi
Sigma
Tau
Omega
123
137
22
121
10
16
73
76
@DEV: This column was left blank to show how a user would manually enter data in a later step / screen.
Map – World – +Export Visualization
– +Scenarios
+ 1 Pre x 3 BDM x 2 PRP3 x
– +Messages
CountryAll
CountryScoreAll
Number of SitesAll
LoremIpsum
All
Export Scenario
China
India
France
Germany
Spain
Bolivia
Mexico
Canada
78
92
15
87
91
53
78
37
100 – 300
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150 – 300
200 – 500
250 – 500
150 – 250
80 – 150
350 – 500
Alpha
Beta
Gamma
Epsilon
Psi
Tau
Sigma
Omicron
Save Lock Scenario
s
s
s
s
CSS Wireframes – Create Country Scenario
IT Clinical Development and IT Human Factors / UX Design – February, 2014
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