This section will cover the study Summary tab (Enterprise version) / Study Details tab (eXpress version). Within this tab, users may navigate to and update study data such as the Study Information, Study Definition, Study Details, Study Design, and Sponsor Information sections. More details on data in each section is provided below.
Summary / Study Detail Sections:
Section Name
Description
Study Information
Users can Copy an Existing Study, change which user entered the study information, select a Principal Investigator, and select a Study Contact.
In the Enterprise version, the study can also be identified:
· If the Principal Investigator was a major author/initiator of this study
· Is the study CTRP Reportable
· Is the study an FDA Regulated Study
Study Definition
Users can modify the Study Number, Study Title, enter a Primary Objective, enter a Summary for the study, and enter or import and NCT Number.
Note: NCT must be listed before the 8-digit number.
Study Details
Users may enter a study Agent/Device, select a Division from the dropdown, select a Therapeutic Area, enter a Study Duration, select a Duration from a dropdown, and enter a total sample size.
In the Enterprise version, the following fields are also available:
▪ Disease Site
▪ Specific Sites
▪ National Sample Size
▪ Estimated Begin Date
Note: The Division controls the values for the Therapeutic Area field.
Study Design
Users may select a study Phase from the dropdown menu, select a Research Type from the dropdown, select what the study is Linked to, or select Coverage Analysis Required from the dropdown.
In the Enterprise version, the following fields are also available:
▪ Study Scope
▪ Study Type
▪ Study Linked To (must be a study in eResearch)
▪ Blinding
▪ Randomization
Sponsor Information
Users may enter or select a Sponsor Type, enter a Sponsor ID, enter a Primary Contact, or enter a Sponsor Name.
In the Enterprise version, the following fields are also available:
▪ If Other (sponsor type)
▪ Other Contact
▪ NIH Grant
Keywords
Keywords are an Enterprise Only feature which allows permissioned users to associate keywords for study searches.
More Study Details
More Study Details are Enterprise Only fields that include the following:
▪ Short Protocol Number
▪ IRB Number
▪ Other Number
▪ Specify Name for Other Number
To modify study summary / study details:
1. Navigate to the correct section, update or add information as needed and save with your e-Signature.
