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# Planned Sites |
Number of sites planned for the protocol. |
# Planned Subjects |
Number of subjects planned for the protocol. |
Actual End Date |
The date on which the study concludes. |
Actual Start Date |
The date on which the study begins. |
Approval Date |
The date on which the protocol was approved by the regulatory authority. |
Central Lab |
The name of the laboratory associated with the study. This is entered through the Accounts screen. |
CRO |
Name of the Clinical Research Organization that is sponsoring the trial. |
Currency Code |
The currency that is used to display the payments, costs, and budgets for the protocol. The default value is USD (United States dollars). NOTE: It is important to specify the Currency Code for the protocol.
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Design |
Information about the type of study. |
Exchange Date |
The date that determines the exchange rate of the currency used. By default, the exchange date for the protocol is the date the protocol is created. |
Objective |
The objective for the clinical trial. |
Phase |
Phase of clinical trial, such as Phase I, II, or III. |
Planned End Date |
The planned end date for the study. |
Planned Start Date |
The planned start date for the study. |
Product |
Only products that have been associated with the clinical program, through the Application field in the Clinical Programs view, can be selected from the Clinical Product and Indication dialog box. For more information about creating a clinical program, see To create a new clinical program. |
Program |
Name of the clinical trial program. |
Protocol # |
Identifying number assigned to the protocol. |
Regions Required |
Flag to indicate the sites for this protocol must belong to a region. For information on regions, see Setting Up Clinical Regions. When this flag is selected, you cannot create sites directly under protocols. You must create regions first and then create sites that are associated with regions. |
Sponsor |
The clinical trial sponsor. |
Status |
The status of the protocol, such as planned, in progress, or completed. |
Team |
Enter the names of those who need access to the protocol, the study manager and others who monitor the clinical trial. |
Title |
Descriptive title for the protocol. |
Type |
Purpose of the protocol. |
Withholding Amount |
The amount to be withheld from each of the payments to the investigators until the trial is complete. This can be overwritten at the Region and Site levels. |
Withholding Percentage |
The percentage to be withheld from each of the payments to the investigators until the trial is complete. This can be overwritten at the Region and Site levels. |