Access and validation

Governance details

Documents or webpages that describe the overall governance of the data source and processes and procedures for data capture and management, data quality check and validation results (governing data access or utilisation for research purposes).
Publication in BMC Orphanet Journal of Rare Diseases on Rationale, design and methods

Biospecimen access

Are biospecimens available in the data source (e.g., tissue samples)?

No

Access to subject details

Can individual patients/practitioners/practices included in the data source be contacted?

No

Description of data collection

The web-based registry collects long-term data on growth hormone treatment in routine clinical care, from consecutive patients newly initiated or receiving maintenance growth hormone treatment. It meets high quality standards through several measures (planned minimum centre contribution, automated plausibility checks of data at entry, statistical checks, queries, monitoring with source data verification in at least 20% of participating centres).
Event triggering registration

Event triggering registration of a person in the data source

Start of treatment

Event triggering de-registration of a person in the data source

Death
Loss to follow up
Practice deregistration

Event triggering creation of a record in the data source

Withdrawal of patient consent
Data source linkage

Linkage

Is the data source described created by the linkage of other data sources (prelinked data source) and/or can the data source be linked to other data source on an ad-hoc basis?

No

Linkage description, possible linkage

The data source may potentially be linked with additional data sources, such as for comparisons with other registries or with post-authorisation safety studies; however, the specific methods for such linkage are yet to be defined.
Data management specifications that apply for the data source

Data source refresh

Every 6 months

Informed consent for use of data for research

Other

Informed consent, other

If pseudonymized data is used for purposes not originally covered in the patient information, ethics committees might require obtaining new informed consent from patients for these new purposes.

Possibility of data validation

Can validity of the data in the data source be verified (e.g., access to original medical charts)?

Yes

Data source preservation

Are records preserved in the data source indefinitely?

No

Data source preservation length

10 years years

Approval for publication

Is an approval needed for publishing the results of a study using the data source?

No

Data source last refresh

Common Data Model (CDM) mapping

CDM mapping

Has the data source been converted (ETL-ed) to a common data model?

No