Stella
FAQ for Site Coordinators
What is STELLA?
This FAQ is for clinicians, research coordinators, and administrative staff at centers that are participating in STELLA or considering joining. For clinical questions about eligibility of a specific patient, contact your site Principal Investigator first.
Joining STELLA
How does my center join STELLA?
Start by emailing the coordinating center at [contact.stellaproject@gmail.com]. We’ll send you the study protocol, eCRF overview, site-feasibility questionnaire, and a site onboarding checklist. Once the feasibility review is complete, we’ll schedule an onboarding call with the PIs.
What does my center need to commit to?
A site Principal Investigator, at least one study coordinator, local IRB/ethics approval, capacity to enroll a minimum of 20 participants per year, and participation in quarterly coordinator calls.
Is there a cost to participate?
No. There are no fees to join STELLA. Sites are responsible for their own local regulatory costs and staff time; STELLA provides the protocol, eCRF, central coordination, and training at no cost.
Is there funding for sites?
STELLA does not currently provide per-patient reimbursement. Where central funding is secured, priority is given to sites with high enrollment and data quality.
Ethics and regulatory
Is STELLA IRB approved?
Yes, at each participating center. Each site obtains its own local IRB/ethics approval before activating enrollment. We provide template IRB submission language, the approved protocol, and sample informed consent forms in English, Spanish, and Portuguese.
Do patients need to sign informed consent?
Yes. All prospective STELLA participants sign informed consent before any study procedure. The template consent is available from the coordinating center and must be locally translated and approved by your IRB.
Can patients withdraw?
Yes, at any time and without affecting their clinical care. A withdrawal option is built into the eCRF.
Eligibility and enrollment
Who is eligible?
Adults (≥18 years) with MASLD, MetALD, or ALD based on the 2023 multisociety nomenclature, plus a healthy control arm. Full inclusion and exclusion criteria are in the protocol — see the «For Investigators» page.
What if a patient doesn’t clearly fit one category?
Use the eCRF’s adjudication workflow. Borderline cases are flagged and reviewed centrally. When in doubt, enroll and flag — do not exclude.
How long does enrollment take per patient?
Approximately 30–45 minutes for the baseline visit, assuming clinical data are already available from routine care. Follow-up visits are shorter (~15–20 minutes).
Data entry and quality
What eCRF are we using?
REDCap, hosted and managed centrally (Pontificia Universidad Católica de Chile). Site coordinators receive individual login credentials after training.
Where is training available?
We hold a 90-minute onboarding webinar for every new site. Recordings, written SOPs, and a data dictionary are available in the site portal. Refresher training is offered quarterly.
What if we have questions about a specific data field?
Submit a data query through the eCRF or email [contact.stellaproject@gmail.com]. Central data managers respond within two business days.
What happens if our data quality flags a concern?
The central team performs monthly data-quality checks. Sites receive a summary report listing open queries, missing fields, and any protocol deviations. Queries should be resolved within 30 days.
Publications and authorship
Will our site get authorship on STELLA publications?
Yes — site Principal Investigators and eligible team members are named co-authors on primary STELLA publications, subject to ICMJE criteria and contribution. See the Authorship & Data-Access Policies page for details.
Can we use STELLA data for our own analyses?
Yes, through the ancillary studies process. Submit a 1–2 page concept sheet to the Steering Committee. See the Authorship & Data-Access Policies page.
Can we present STELLA data at local meetings?
Aggregated site-level data (your center’s own enrollment and clinical patterns) can be presented locally with attribution to STELLA. Analyses using the multinational dataset must be approved by the Steering Committee first.
Communications
Who is my main point of contact?
The coordinating center at [contact.stellaproject@gmail.com] handles day-to-day questions. Strategic or scientific questions go to the PIs directly; your Steering Committee country representative is your first line for regional issues.
How often are coordinator meetings?
Quarterly, virtual, ~60 minutes. Invitations are sent 2 weeks in advance. Meeting notes are posted to the site portal.