Clinical Data Management System
GPTKB entity
Statements (42)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:software
|
| gptkbp:canBe |
cloud-based
on-premises |
| gptkbp:compatibleWith |
gptkb:ICH-GCP
gptkb:21_CFR_Part_11 |
| gptkbp:enables |
remote monitoring
real-time data access regulatory submissions |
| gptkbp:example |
gptkb:Medidata_Rave
REDCap OpenClinica Castor EDC Oracle Clinical |
| gptkbp:features |
audit trails
role-based access control data backup data extraction query management data locking electronic case report forms |
| gptkbp:guarantees |
gptkb:legislation
data integrity |
| https://www.w3.org/2000/01/rdf-schema#label |
Clinical Data Management System
|
| gptkbp:improves |
data quality
|
| gptkbp:purpose |
manage clinical trial data
|
| gptkbp:reduces |
data entry errors
|
| gptkbp:relatedTo |
biostatistics
data management plan pharmacovigilance electronic data capture clinical trial management system |
| gptkbp:supports |
data collection
data storage data validation data export data cleaning |
| gptkbp:targetUser |
biostatisticians
clinical data managers clinical research associates |
| gptkbp:usedIn |
clinical trials
|
| gptkbp:bfsParent |
gptkb:CDMS
|
| gptkbp:bfsLayer |
8
|