Study identification

PURI

https://redirect.ema.europa.eu/resource/33722

EU PAS number

EUPAS33148

Study ID

33722

Official title and acronym

Can We Rely on Results From IQVIA Medical Research Data UK Converted to the Observational Medical Outcome Partnership Common Data Model?

DARWIN EU® study

No

Study countries

United Kingdom

Study description

Exploring and combining results from more than one real world data (RWD) source might be necessary in order to explore variability and demonstrate generalisability of the results, or for regulatory requirements. However, the heterogeneous nature of RWD poses challenges when working with more than one source, some of which can be solved by analysing databases converted into a common data model (CDM).The main objective of the study was to evaluate the implementation of the Observational Medical Outcome Partnership (OMOP) CDM on IQVIA Medical Research Data (IMRD) UK data. A drug utilisation study describing the prescribing of codeine for pain in children was used as a case study to be replicated in IMRD-UK and its corresponding OMOP CDM transformation. Differences between IMRD-UK source and OMOP CDM were identified and investigated.

Study status

Finalised
Research institution and networks

Institutions

Contact details

Gianmario Candore

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Data collection

Planned:
Actual:

Start date of data analysis

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
EMA
Study protocol
Initial protocol

Protocol - final

English (690.92 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable