Glossary

AMG: study tag assigned to every AMG regulated study.

Annotation: semantic annotation giving a fixed meaning to specific eCRF item.

BIO: study tag assigned to study collecting biospecimens withing biobank.

BIO-code: project code assigned to study within biobank.

CCP: study tag assigned to study using CCP project specific pseudonymisation.

CCP-code: unique CCP trial registry code.

Clinical Stage: refers to identifiable DICOM data in clinical PACS archives.

Component: one specific software system (such as EDC, PACS or LAB) that is integrated into the RPB platform.

CMS: news article content management system.

CTMS: clinical trial management system.

DICOM: study tag assigned to study collecting medical imaging or treatment planning data.

DICOM-RT: radiotherapy specific extension of DICOM standard used for representation of radiotherapy specific entities such as plan, structure sets and dose files.

DKTK: study tag assigned to study with DKTK informed consent.

Dummy-run: process of site qualification for particular clinical trial.

eCRF: electronic case report form.

EDC: an electronic data capture system for conduction of eCRF data.

EDC-code: unique code assigned as study tag to every study configured to use EDC component.

ePRO: electronic patient reported outcomes.

IDAT: study tag assigned to study when site patient pseudonyms are derived from identifiable data.

Mobile: table friendly component to collect electronic patient reported outcomes.

LAB: laboratory data management system with file repository and tabular data storage.

PACS: a picture archiving and communication system for storage of DICOM data.

PACS Cluster: collection of PACS nodes within the platform.

PACS Data Node: PACS DICOM node that stores DICOM data.

PACS Proxy: PACS DICOM node that does not store data but redirect the search requests to specific PACS data nodes.

Partner Site: institute which join a study as a site location.

Person: human entity that is involved in the clinical research process with specific role or is participating as subject in specific trial.

PID/ Pseudonym/ Person ID: the unique identifier for subject within a scope of whole RPB platform instance.

Project Agnostic Stage: refers to de-identified DICOM data staged into Study0 for screening purposes.

Project Specific Stage: refers to de-identified DICOM data staged for specific research project for data evaluation purposes.

Protocol Code/ ID: unique code assigned to study protocol.

RPB Platform: the collection of tightly integrated software systems that form a core software infrastructure necessary to support translational radiotherapy research projects.

RTStruct: DICOM series storing delineation of region of interests.

Site: clinical or pre-clinical trial or research project with all it’d data and meta-data limited to specific research location.

Staging: process of de-identification of DICOM data.

Study0: project agnostic subject registry used for screening purposes.

Study: clinical or pre-clinical trial or research project with all it’d data and meta-data, which can be mono- (one site location) or multi- (multiple site locations) centre.

Study Subject: a subject entity that have been enrolled into a specific study.

Study Subject ID: identifier that is unique for subject within a scope of a specific study.

Study Tag: label appended to study that can hold true/false or identifier values.

Subject/ Patient: entity that will be the target of examination within specific study.