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Configurator
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1
Which tool(s) do you want to configure?
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●EDC: Capture, validate and enrich subject data. ●CTMS: Manage & track the entire study start-up & portfolio. ●ERMS: IRBs can review & manage all clinical study protocols electronically.
Electronic Data Capture | EDC
Clinical Trial Management System | CTMS
Ethical Review Management System | ERMS
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2
Please enter the number of studies:
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Please enter the number of studies
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3
Please enter the average duration of a study:
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Duration in months
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4
How many records are involved in a study?
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Up to 100 records
Up to 250 records
Up to 1000 records
> 1000 records
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5
How many centers are involved in a study?
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Single center
Up to 3 centers
Up to 10 centers
> 10 centers
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6
How many users are involved in a study?
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Up to 2 users
Up to 5 users
Up to 20 users
>20 users
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7
How many users are involved in a study?
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Up to 5 users
Up to 20 users
Up to 50 users
> 50 users
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8
Which type of support is preferred?
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Online ticketing support
Online ticketing support + telephone & chat support
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9
Which EDC functionalities will be used?
ePro/eCOA: Survey tool to send questionnaires to patients.
Randomisation & Stratification
Trial Supply Management: Manage the inventory and dispensing of medicines.
Subject Tracking: Plan and manage visits.
Financial management: manage budgets, expenses and fees.
50GB+ data storage
None of these functionalities will be used
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10
Which CTMS functionalities will be used?
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Generate registration forms & letters
Document Management: Lock & manage eTMF & ISF documents
Review & sign documents
Communication Management: Easily communicate with all involved roles.
Financial management: manage budgets, expenses and fees.
Study & Management dashboards
Prepare and manage Smart Safety Reports, amendments and progress reports.
Multiple processes/workflows: (for example due to different types of study requests)
A digital connection with an affiliated Medical Ethical Review Committee.
EDC integration to capture all data
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11
Which ERMS functionalities will be used?
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Generate & validate letters electronically
Study Management: Manage study protocols, Smart Safety Reports, amendements and progress reports
Review, sign & lock documents
Communication Management: Easily communicate with submitters & principal investigators.
Online meetings: Meet online with chairpersons and members.
Study & Management dashboards
Prepare and manage Smart Safety Reports, amendments and progress reports.
Workflow Management: Integrate adaptable workflows
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12
Which EDC services will be used?
Training
Integrating questionnaires into the eCRF
Data migrations
Specific APIs
None of these services will be used
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13
Which CTMS services will be used?
Training
Data migrations
Specific APIs
None of these services will be used
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14
Which services will be used?
Training
Integrating questionnaires into the eCRF
Data migrations
Specific APIs
None of these services will be used
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15
Contact details
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First name
Surname
Name of institution or company
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