Requirements to Become an Enroll-HD Site
These guidelines define the structure and composition of an Enroll-HD site.
- Access to patients within a reasonable geographical area who are prepared to participate in a non-treatment observational study.
- Sites should be prepared to aim for recruitment and retention of a minimum of at least 20 participants.
- Each patient should be followed up at annual visits
- Clinic space allowing for interview and assessment of patients and their families/carers during core assessments of up to 45 minutes of duration. Preferably with the ability to increase this to accommodate extended or optional assessments and/or clinical studies.
- Ability to draw, process and dispatch blood samples to a central laboratory
- Ability to access the Enroll-HD web portal and enter data onto an electronic data capture system allowing direct data entry during, or at least within 1 week after, patient assessments.
- Each site has an MD associated with the site team. It is preferable that the PI has an MD and expertise in HD. However, we realise that in certain regions there are equally qualified and appropriately trained PhDs who can serve as PIs.
- Site staff should have a working knowledge of English.
- Trained study staff including an Investigator with specialist interest, experience and a willingness to undertake training in Enroll-HD specific assessments and relevant annual certification.
- Ideally, the same rater should assess a given subject throughout all of their assessment visits
- From a risk management perspective (e.g. suicidality), there should be at least a recognised referral path for mental health issues to a Psychiatrist or other mental health care provider, preferably with HD experience. In the optimal arrangement, these individuals are an integral part of the HD care team and process.
- A referral path should be available for those Enroll HD participants who wish to undergo genetic testing.
- It is strongly suggested that there should be at least one other member of staff available at least part time to provide administrative and/or coordination support.
- Staff should be encouraged to complete Good Clinical Practice (GCP) certification
- Access to a GCP-compliant local or regional Ethics Committee, Institutional Review Board (IRB) or equivalent
- Access to and awareness of any other local or regional agency approvals
- Ability to contract via local institutional (public or private) finance/legal department