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).

Biospecimen access

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

Yes

Biospecimen access conditions

Data Protection: Any data derived from the biospecimen should be anonymized to protect patient confidentiality. Identifying details should be stored separately from the research data and be accessible only to authorized personnel.
Destruction or Return: After the research is completed, the biospecimen should either be returned to the patient (if they requested it) or destroyed in a manner that ensures it cannot be used further. Documentation of this process is required. Consent: Before accessing any patient's biospecimen, written informed consent from the patient is mandatory. The consent form should detail the purpose of accessing the specimen, potential risks, and benefits, as well as the patient's rights to withdraw consent at any time.

Access to subject details

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

Yes

Description of data collection

After diagnosis is confirmed, patients sign a consent form. We collect all the data we need and enter it into the OpenClinica data collection software. The process of obtaining consent, collecting data, and entering it is managed by a data manager. Separately, we collect paper histories and consent forms.
Event triggering registration

Event triggering registration of a person in the data source

Disease diagnosis
Start of treatment

Event triggering creation of a record in the data source

Patients with newly diagnosed lymphoproliferative disease who were hospitalized for treatment.
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?

Yes

Linkage description, pre-linked

Patient data spanning from registration, baseline details (including staging and laboratory results), pathology reports, therapy details (restaging, actual administered therapy, and planned treatments), to follow-up records are all integrated within OpenClinica to offer a holistic understanding of each lymphoma patient's medical journey.

Linked data source 1

Pre linked

Is the data source described created by the linkage of other data sources?

Yes

Data source, other

REGISTRATION; BASELINE (STAGING, LABORATORY); PATHOLOGY, THERAPY (RESTAGING, ACTUAL THERAPY, PLANNED TREATMENT); FOLLOWUP

Linkage variable

Patient's unique ID you use in OpenClinica.
Data management specifications that apply for the data source

Data source refresh

Every 6 months

Informed consent for use of data for research

Required for general use

Possibility of data validation

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

No

Data source preservation

Are records preserved in the data source indefinitely?

No

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?

Yes

CDM Mappings

Data source ETL CDM version

5.4

Data source ETL status

In progress