Data Administration Selection Lists: Application Maintenance
The following table identifies the selection lists (drop-down lists and multi-select boxes) in Calyx RIM. Some of these lists will be populated with values when shipped with the software. For those lists, the table identifies where the values were obtained.
| Selection List Entity | Source for Values |
|---|---|
| Age Span Population Values | Clinical Trial Application Form |
| Application Category Values | Calyx Defined: Best Practices |
| Application Status Values | Calyx Defined: Best Practices |
| Application Type Values | Regulatory Agency Guidance
(US: application-type.xml v1.1) Regulatory Agency Defined |
| Chief Investigator Values | Client Defined |
| Country Values | ICH Website: 2 digit ISO Codes |
| CTA Product Role Values | Calyx Defined: Best Practices |
| Legal Status Values | FDA Website; EMA Defined |
| MedDRA Term Values | Client Defined |
| Medical Condition Investigated Values | Client Defined |
| Procedure Type Values (per Country) | XEVMPD Controlled Vocabularies - Authorisation Procedures
Calyx Defined: Best Practices |
| Reason for Premature Ending Values | Clinical Trial Application Form |
| Region Values | Client Defined |
| Region Type Values | Client Defined |
| Sponsor Type Values | Client Defined |
| Trial Design Values | Clinical Trial Application Form |
| Trial Phase Values | Clinical Trial Application Form |
| Trial Scope Values | Clinical Trial Application Form |
| Trial Subject Groups Values | Clinical Trial Application Form |