Complete all fields in the application form below. For any questions about completing this form, please contact clinicaltrialsite@enroll-hd.org.

Please note that applications also require supporting documentation listed below to be submitted to clinicaltrialsite@enroll-hd.org (i.e. GCP certificates, CVs, SOPs)
GSID-HD
Please note that you should ensure full completion of all fields in the Global Site Investigator Database (GSID-HD), including details about all staff members, before proceeding with this application form.
GSID-HD responses will be used to support the application for certification and as a basis for assessment feasibility for clinical trials so it is important that the information entered is accurate and complete.  
If your site does not already have an entry in GSID-HD, please click here to add site details. For assistance with completing the GSID-HD, or if you cannot access an existing account please contact gsid@enroll-hd.org.

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* 1. The GSID-HD must be completed before submitting this form.  Please confirm that the site has a fully completed and up-to-date GSID-HD entry:

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* 2. Enter the contact details of the person completing this form

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* 3. Enter site name and country (ensure  this is the same as the site name in GSID).

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* 4. Enter site name as it should be displayed on the certificate (applicable only for Enroll-HD sites applying for certification):

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* 5. Does your site currently have >50 HD participants in the Enroll-HD study?

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* 6. Confirm that you have a member of staff (not the PI) on the clinical trial team who performs the role of study co-ordinator and that there is another investigator/sub-investigator who can act as a back-up for the PI, and that their details are entered in GSID-HD

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* 7. Confirm that there is a MD (Physician/medical doctor) on the clinical trial team and that their details are entered in GSID.

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* 8. Applicable only for sites not participating in Enroll-HD: Does your site have a current  certified UHDRS motor rater? If training is required please contact clinicaltrialsite@enroll-hd.org.

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* 9. Confirm that clinical trial staff (at a minimum the PI and SC named in GSID-HD) are fluent in the English language.

Items below (10-14) require documentary evidence of GCP training, CVs and applicable SOPs to be submitted to clinicaltrialsite@enroll-hd.org, as soon as possible after making this application. Please include site name in the email subject title.

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* 10. Confirm that all clinical trial staff listed in GSID-HD (PI, sub-Is, raters, study coordinator) have completed GCP training within the last 3 years and that either:
 - documentary evidence of GCP training (e.g. scanned copy of certificate, confirmation email) will be submitted to clinicaltrialsite@enroll-hd.org, including site name in the email subject title.
OR
 -  GCP training has been completed via the Enroll-HD training portal (records will be checked by the Enroll-HD Clinical Trial Committee)

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* 11. Confirm that CVs for all clinical trial staff listed in GSID-HD (PI, sub-Is, raters, study coordinator) will be submitted to clinicaltrialsite@enroll-hd.org.
Please include site name in the email subject title.

A requirement for certification is that appropriate Standard Operating Procedures (SOPs) are in place for informed consent, handling of study drug and handling of medical and psychiatric emergencies. Please confirm in the next questions whether you already have such SOPs in place. If no formal SOP is currently in use at your site, we can provide templates for you to adapt to your local procedures. Indicate below if you require these. 

If no formal SOPs are currently in use and a template SOP is required for adaptation, a site must agree to implement the required SOPs within 6 months of certification.

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* 12. Does your site have a SOP for informed consent? 
If yes, submit SOP to clinicaltrialsite@enroll-hd.org. Please include site name in the email subject title.

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* 13. Does your site have a SOP(s) for handling of study drug (storage, accountability etc.):
If yes, submit SOP(s) to clinicaltrialsite@enroll-hd.org. Please include site name in the email subject title.

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* 14. Does your site have a SOP for handling medical and psychiatric emergencies for research participants?
If yes, submit SOP(s) to clinicaltrialsite@enroll-hd.org. Please include site name in the email subject title.

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* 15. Check the boxes below to confirm agreement with the following statements:

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