Actors
Who and which systems are involved? Make actors “real”, since details matter. Some example actors:
Researcher Tiana, a Postdoc, is setting up a new study project in a patient population
Amsterdam UMC
Health-RI Servicedesk
Description
Tiana wants to make sure that her data will be available for future research and wants to make sure that others understand her data and that the dataset can be used to link to other datasets as well
Conditions
Tiana is using validated data capturing software (Castor EDC) to collect her data
She is collecting different types of data that may need different types of terminology standards:
Diagnosis
symptoms
medication
co-morbidities
Values from collected blood samples
Saliva, urine, and feaces
Actor perspective
Tiana contacts Amsterdam UMC’s local Research Support to ask whether knowledge and support in choosing and applying a terminology standard or multiple terminology standards.
During a support intake, the goal of applying such standards are discussed:
As the data collection will span several years and will include 2000 patients, these data are very valuable, also for other researchers outside if the project group. Applying such standards will facilitate interoperability so that others, humans or machines, can find, interoperate, and reuse them (source: I2: (Meta)data use vocabularies that follow the FAIR principles - GO FAIR (go-fair.org))
Research Support refers the researcher:
To internal experts. Colleagues who have knowldege on systems such as CDISC (SDTM, SEND, CDASH), SNOMED CT, LOINC, etc. Not sure how much hands-on experience is present within Amsterdam UMC.
To EVA Service Center (service desk Electronic Health Record (EHR)). In the EHR (Epic), the ICD-10 codes are partially applied to some data fields. It is possible to extract parts of the data that contains standardized variables.
Might be possible to map other standards to one chosen standards.
Might be possible to use existing codebooks → referral to Jeroen Beliën and Sander de Ridder for advice on the iCRF Generator
Might be possible to collect data with standardized CRFs from Castor EDC Form Exchange. Preferably forms that have been approved by Amsterdam UMC (working group in process of evaluation).
Alternative Flow
Describe alternatives, basically when things don’t go according to your normal flow.
Alice logs into CASTOR but gets a password error
She resets her password
The XYZ-study is not visible
She contacts the study owner wait for appropriate permissions