ODMXMLTools.jl is a simple tool set for working with ODM-XML.
ODM-XML is a vendor-neutral, platform-independent format for exchanging and archiving clinical and translational research data, along with their associated metadata, administrative data, reference data, and audit information. ODM-XML facilitates the regulatory-compliant acquisition, archival and exchange of metadata and data. It has become the language of choice for representing case report form content in many electronic data capture (EDC) tools.
The ODM has been designed to be compliant with guidance and regulations published by the FDA for computer systems used in clinical studies.
See CDISK site for more information.
import Pkg; Pkg.add(url="https://github.com/PharmCat/ODMXMLTools.jl.git")
With ODMXMLTools.jl you can:
- Import ODM xml file;
- Get table of MetaDataVersion;
- Find study elements;
- Build MetaDataVersion (recursive resolve all includes in MetaDataVersion);
- Get study list;
- Get events table;
- Get forms table;
- Get ItemGroups table;
- Get items table;
- Get study subject information;
- Get study information;
- Get ClinicalData list;
- Get data from ClinicalData in “long” format;
This package currently is not registered because I don’t know would it be in demand.
This package does not validate odm.xml file, but a structure validation procedure may be developed in the future.
This package is not for changing odm.xml file and not writing it.
This program comes with absolutely no warranty. No liability is accepted for any loss and risk to public health resulting from use of this software.