Overview
Study Configuration is used to set study information as well as setting supporting functions according to study protocol.
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Update Study Configuration
To configure the information and settings of the study, user needs to access the 'Study Configuration' function in the build study page
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Field | Required? | Description | Filling instructions |
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Unique Protocol ID | Unique Protocol ID is set by the sponsor. This Unique Protocol ID is unique and does not match any other protocols. | Maximum 30 characters | |
Brief Title | Short title of study is written in simple languages. Title should include information on participants, statuses being evaluated, and studied interventions | Maximum 100 characters | |
Official Title | Study's official title | Maximum 255 characters | |
Study System Status | Study's current status | ||
Secondary IDs | Other IDs of the study | Can input multiple comma-separated IDs | |
Principal Investigator | Maximum 255 characters | ||
Brief Summary | |||
Detailed Description | Maximum 1000 characters | ||
Sponsor | Maximum 255 characters | ||
Study Phase | Current Study Phase | Select from one of many phases of a clinical trial Read more on phases in a clinical trial here. | |
Protocol Type | Select from one of the following:
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Protocol Verification / IRB Approval Date | |||
Study Start Date | |||
Study Completion Date | |||
Purpose | |||
Allocation | How study subjects are allocated in the study | Select from the following:
Find out more here. | |
Masking | Select from the following:
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Control | Select from the following:
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Intervention Model | Select from a list of values. Find out more here. | ||
Study Classification | Select study classification. |
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Field | Required | Filling instructions |
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Facility Name | Maximum 255 characters | |
Facility City | Maximum 255 characters | |
Facility State/Province | Maximum 20 characters | |
Postal Code | Maximum 64 characters | |
Facility Country | Maximum 64 characters | |
Facility Contact Name | Maximum 255 characters | |
Facility Contact Degree | Maximum 255 characters | |
Facility Contact Phone | Maximum 255 characters | |
Facility Contact Email | Must following follow email format |
Related Information
Field | Required? | Filling instructions |
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MEDLINE Identifier | Maximum 255 characters | |
Results Reference? | ||
URL Reference | Maximum 255 characters | |
URL Description | Maximum 255 characters |
Study Parameter Configuration
Trường dữ liệu | Bắt buộc | Hướng dẫn nhập liệu |
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Collect Subject Date of Birth? | Select from the following:
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Allow Discrepancy Management? | Select from the following:
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Sex Required? | Select from the following:
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Person ID Required? | Select from the following:
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Show Person ID on CRF Header? | Select from the following:
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Method to generate the Study Subject ID? |
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Study Subject ID Auto Increment Strategy | Select from the following:
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When Performing Data Entry, Interviewer Name Required? | Select from the following:
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Interviewer Name Default as Blank? | Select from the following:
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Interviewer Name Editable? | Select from the following:
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Interview Date Required? | Select from the following:
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Interview Date Default? | Select from the following:
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Interview Date Editable? | Select from the following:
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Secondary Label Viewable? | Select from the following:
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Forced Reason For Change in Administrative Editing? | Select from the following:
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Visit Location Required? | Select from the following:
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Auto Lock CRF After Sign? | Select from the following:
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Auto Freeze CRF After Verify? | Select from the following:
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