Information for healthcare professionals

Find all the resources you need to process information about participants in the BILAG BR Study.

Introduction
Entering data

If you are on the study delegation log for your centre and need a log in for the database, please contact the study team for this.

Please enter data for BILAG BR participants here.

Documents

Download all current documents for the study in a ZIP file (3.6MB)

This includes all documents to consent, register and follow up participants on the study.

You can also download a delegation log and enrolment log for your records.

Study recruitment

A participant must give their consent before registration with the study.

It is preferred that all local staff working on the study who are responsible for obtaining consent undertake good clinical practice (GCP) training at the frequency specified by their Trust.

The participant should be given or sent a copy of the patient information sheet to read before signing the consent form for the study and patients must have the study information for at least 24 hours prior to consent.

To register a patient, please fax or send a copy of the completed registration and consent form to the study team.

We can only accept these by encrypted email or post, so please do not send by regular email. We will then add the patient to the study database and their record will become available for online data entry.

Data and sample collection

Data collection

You will need to collect routine clinical data, including disease activity measures, from patients at regular time points, and submit it using the online study database. We ask for this data:

  • at baseline
  • three months after first treatment
  • six months after first treatment
  • and then annually.

However, as an observational study, we realise that clinic appointments may not always fit exactly with our follow up time points. If you are unsure about how to enter particular data, please contact us.

Sample collection

We also ask for blood and urine samples to be collected:

  • at baseline
  • three months after first treatment
  • six months after first treatment
  • 12 months after first treatment.

The table below has more details.

Type of participant

Prospective – samples collected before (next) treatment

Retrospective – samples collected after treatment

Biologic Retreatment of same biologic

 

New Biologic Treatment (including switching within study) / Control

Control to biologic switch

1st Biologic Treatment

Baseline

Red plain tube;

purple EDTA tube;

blue mRNA tube;

urine sample

Red plain tube;

purple EDTA tube;

urine sample

 

Red plain tube;

purple EDTA tube;

urine sample

6 month

Red plain tube;

purple EDTA tube;

blue mRNA tube;

urine sample

Red plain tube;

purple EDTA tube;

urine sample

 

 

No samples collected

12 month

Red plain tube;

purple EDTA tube;

urine sample

No samples collected

Patient questionnaires Patients will be asked to complete a set of questionnaires at regular intervals. For prospectively recruited patients, we would like to have these completed as close to the start of therapy as possible, we would therefore ask that these are given out in the clinic, with a prepaid envelope for their return. Otherwise, these will be sent out by the study team.