The TARGET Consortium
GCAT for Health Professionals
Are you a health professional in the rheumatology field who would like to learn more about the GCAT Registry?
The GCAT Registry is the UK post-marketing surveillance registry to study the effectiveness, safety and prescribing habits of tocilizumab for the treatment of giant cell arteritis (GCA) in the UK National Health Service, nested within the existing structure of the UK GCA Consortium and UKIVAS studies. It recruits patients who have been diagnosed with GCA and who have either been prescribed tocilizumab (cases) or who have not been prescribed tocilizumab (controls) to treat their GCA.
Currently, all data is collected by health professionals via paper forms. Each of the forms required to register and follow up patients can be found here, along with all adverse event forms. We are in the process of developing an online portal for data to be entered directly to the study from sites. This is expected to be introduced in summer 2019.
Clinical baseline documents are required for each new patient registered in the GCAT Registry. Please ensure you consult the eligibility checker to confirm the patient is eligible for the GCAT Registry before recruiting them. Once you have completed the registration documents (as listed on our Enrolling a Participant Checklist) please post them to the GCAT Registry offices or email them (Louise.firstname.lastname@example.org) We will then register the patient and inform you when their next follow-up is due.
Follow-up data is collected every six months for 1.5 years. The documents below are used to collect the data on paper forms, which can posted back to the GCAT Registry offices.
Serious adverse events
The GCAT Registry collects details of adverse events from clinicians only. Not all adverse events are considered as ‘serious’. Below is the definition that the GCAT Registry uses to determine how to categorise an event.
A serious adverse event or reaction is an untoward medical occurrence that is considered to represent a significant hazard to the patient. This definition is derived from regulatory authorities, including the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), and includes events that result in:
2. Life-threatening (immediately)
3. Overnight hospitalisation (initial or prolonged)
4. Requires an intravenous antibiotic/anti-viral/fungal drug
5. Significant loss of function or disability
6. Congenital malformation/birth defect
7. Other medically important event*
* Certain adverse events may not necessarily belong to any of these classifications but are still considered medically significant/important and should be considered serious (i.e. all malignancies and pregnancy).
Adverse event data is a key element of our research so it’s important that we make sure the data we use is correct. The most essential pieces of information when recording an event are:
◊ Date of event*
◊ Biologic/targeted therapy details at time of event (these should be recorded on pg. 1 of the clinical follow up and noted with the event where discontinued due to the event)
◊ Was the event serious & why? (SAE criteria e.g. required IV antibiotics)
◊ Is the event related to the biologic/targeted therapy
*Where the patient was hospitalised admission/discharge are also very useful if available.
Elective procedures (e.g. joint replacements) that include overnight hospitalisation are not automatically considered as a serious event unless the hospital stay is prolonged due to complications (e.g. infection). However we would still like to know about planned surgeries, and in particular why they were performed, as it will be the indication for the surgery that is an event rather than the procedure itself.
Some serious events are also classed as an Event of Special Interest (ESI) if the event is one we would appreciate receiving the ESI form at the same time as the follow up form. You could also include a discharge summary or clinic letter that you feel has relevant additional information to the serious event.
We may write to you to ask for further information on some events so if you have no further information regarding an SAE please let us know by writing this on the FUP as we will not bother you with repeated requests for information we know you do not have.
Help with adverse events and ESIs
If you have any queries related to adverse events of ESIs, team will be happy help you.
Tel: +44 (0)113 3437764