Clinical Trial Shared Data Attributes
You can create Clinical Trial Shared Data for a product family to associate common details to more than one CTA or IND.
| Attribute | Description |
|---|---|
| Age Span Population | Indicates the age range of subjects included in the study, such as adult or adolescent |
| Condition Considered a Rare Disease | Indicates whether the condition studied is a rare disease |
| CT Shared Data Add Comment | Comments to share with other users in a discussion thread that are stamped with the date, time, and user ID for the entry |
| CT Shared Data Comment | Comments stamped with the date, time, and user who created them |
| CT Shared Data Description | Text that describes the content of the shared data |
| CT Shared Data Keywords | Terms used to search for the data within the system |
| Data Monitoring Committee | Indicates whether independent experts are monitoring a clinical trial |
| EudraCT Number | Unique number assigned by the European Commissions EudraCT database process |
| Family Code | Read-only field that displays the code identifying the product family |
| Family Name | Read-only field that displays the product family name |
| Gender | Use to specify the gender studied in single-sex clinical trials |
| Indications/Intended Use | The condition the drug is intended to treat |
| ISRCTN | The numbering scheme used to uniquely identify a clinical trial worldwide |
| Investigator Brochure Version | The version identifying the Investigator Brochure used in the the clinical trial |
| Investigator Brochure Version Date | The date of the Investigator Brochure Version |
| LPLV Achieved | The date that the Last Patient Last Visit status was achieved for the clinical trial |
| Main Trial Objective | The reason for performing the clinical trial |
| Medical Condition Investigated | The medical condition that is the primary focus of the clinical trial |
| MedDRA term | The MedDRA term used to identify the the purpose of the trial |
| Planned # Subjects in EU Community | The number of subjects in the EU community that are intended to be included in the clinical trial |
| Product Family Type | Read-only field that displays the type of product family, such as Pharmaceutical |
| Protocol Code Number | The identification number for the protocol (study plan) used in the clinical trial |
| Protocol Title | The title for the protocol used in the clinical trial |
| Secondary Objective | The secondary reason for conducting the clinical trial |
| Studying for Rare Disease | Indicates whether the clinical trial involves study of a rare disease |
| Sub-Study Information | An ancillary study added to the clinical trial |
| Trial Design | The planned trials and experiments for a clinical trial, such as randomized or double-blind |
| Trial Phase | The phase of the clinical trial, such as Phase I |
| Trial Scope | The focus of the clinical trial, such as safety or therapy |
| Trial Subject Groups | Identifies conditions defining the subject groups |