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# Planned Sites |
Number of sites planned for the protocol. |
# Planned Subjects |
Number of subjects planned for the protocol. |
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. |
Design |
Information about the type of study. |
Phase |
Phase of clinical trial such as Phase II, or III. |
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 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. |
Status |
Protocol status such as planned, in progress, 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 may 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 may be overwritten at the Region and Site levels. |