Huntington's Disease Global Site & Investigator Database
 
The purpose of this questionnaire is to identify sites that meet specific clinical criteria (including GCP compliance) for developing clinical studies and trials for Huntington's disease. The data will be collected from these sites and contained within a confidential investigator database: the Huntington's Disease Global Site & Investigator Database (GSID-HD).

Please read information below carefully before completing this questionnaire:

Once you have completed the questionnaire, click on one of the buttons at the top and bottom of the form to submit the questionnaire, and an email will be sent to you confirming receipt of your submission. Please note that the General Information section needs to be completed and that information (including email addresses) must be completed for Principal Investigator (PI) and Site Administrative Contact for GSID Edits before the form can be saved as either a draft or submitted. Periodically, the Site Administrative Contact and PI as listed on your site's GSID-HD record will receive an automatically generated email as a reminder to update your site information. Please note that the information can only be updated using the email address listed under these users. Therefore, please make sure to keep this field up-to-date in case there are any changes at the site.

Should you have any remaining questions, please contact gsid@enroll-hd.org.
 
             
 
             
     

General Information
 
Site Name
 
Facility Type
 
 
Address
 
 
 
City
 
State/Province
 
Postal Code
 
Country

Key Personnel Information
 
Site Administrative Contact for GSID Edits
 
Principal Investigator (PI)
 
Other Site Investigators
 
Primary Study Coordinator
 
Backup Study Coordinator (if applicable)
 
On-Site Psychologist/Neuropsychologist
 
Backup Psychologist/Neuropsychologist
 
Other Personnel (e.g. Regulatory Document Specialist, Data Entry, etc.)

Studies/Trials
 
Does your center have previous HD and/or *premanifest HD clinical trial/research study experience?
 
*Premanifest are subjects who are expanded CAG-repeat positive who are not diagnosed with HD
 
Does your center currently have premanifest HD or HD clinical trials/research studies ongoing?
 
Experience with and participation in ongoing neurodegenerative disease (e.g. Parkinson's, Alzheimers, etc.) clinical trials/research studies over the last three years
 
List the groups (i.e. HSG, PSG, etc.) that the site/investigator participates in

Client Research Information
The following questions deal with experience in previous clinical trials, patient populations, subject recruitment, regulatory review timelines and contracts & budgets
 
A.1 Neurology / Huntington's Disease
 
A.1.1 - Do you have affiliated research sites or satellite sites/clinics?
 
A.1.2 - Does the site have experience in recruiting HD patients or premanifest HD subjects for clinical trials?
 
A.1.3 - In the past year, how many HD patient clinic visits have occurred at the site?
 
A.1.4 - How many HD patients and/or premanifest HD do you see on a regular basis for medical management?
 
A.1.5 - How many HD subjects do you currently have enrolled in a clinical trial?
 
A.1.6 - Approximately how many premanifest HD patients do you have access to through your practice?
 
A.1.7 - Please describe the referral network for your HD patient population (e.g., referring neurologists, HDSA, genetic counseling center).
 
A.1.8 - Describe the geographic catchment area that your site primarily serves.
 
A.1.9 - Does the site have any additional means of recruiting HD subjects or premanifest subjects for clinical trials (i.e. patient database, affiliated hospitals, etc.)?
 
   
(a)
(b)
 
A.1.10 - For your HD clinical trials, what is the average number of manifest patients your site has recruited (a) / can recruit (b) per month?
 
A.1.11 - For your HD clinical trials, what is the average number of premanifest patients your site has recruited (a) / can recruit (b) per month?
   
(Study 1)
(Study 2)
 
A.1.12 - In the last two (2) completed HD clinical trials/studies the site participated in, how many patients/subjects did the site recruit?
 
A.1.13 - In the last two (2) completed HD clinical trials/studies the site participated in, what was the site's recruitment commitment going into the study?
 
A.1.14 - Does the site have success and experience recruiting age and gender matched healthy volunteers for clinical studies?
 
A.1.15 - Does your site have access to a clinical trials research center/facility (e.g. a GCRC or CRC) that can be used for HD clinical studies?
 
A.1.16 - Do you have access to inpatient facilities for research participants?
 
A.1.17 - Where are your HD studies conducted?
 
 
A.2 Compliance
 
A.2.1 - Has the site been audited by Sponsor companies?
 
 
A.2.2 - Has the site been audited by the FDA or any other Regulatory Health Authorities?
 
 
A.3 Institutional Review Board (IRB) or Independent Ethics Committee (EC)
 
A.3.1 - Institutional Board (IRB) or Independent Ethics Committee (EC) Name
 
A.3.2 - How often does your IRB/EC meet per month?
 
A.3.3 - How many days in advance does documentation need to be submitted to IRB/EC prior to their review meeting?
 
A.3.4 - Is your IRB/EC subject to delays/backlogs?
 
 
A.3.5 - Will your IRB/EC perform a provisional review of a final approved protocol before it is submitted to Regulatory Agency?
 
A.3.6 - Can your site use a Central IRB/EC (US Only)?
 
 
A.3.7 - In addition to the IRB/EC are there additional review bodies within the institution (e.g. radiation safety committee, research review, local health authorities) which require review/approval?
 
 
A.3.8 - On average, how long does it take for your IRB/EC to approve a protocol and begin the study? (from first submission of documents to receipt of IRB/EC approval letter)
 
A.4 Finance / Legal
 
A.4.1 - Budget Contact
 
A.4.2 - Contracts/Legal Contact
 
A.4.3 - Please confirm that your institution is willing to negotiate a "standard" clinical trial agreement?
 
A.4.4 - On average, for your institution how long does it take from receipt of a final clinical study protocol to a fully executed contract and IRB/EC review and approval?
 
A.4.5 - Can IRB and contract/budgets be submitted and reviewed in parallel?
 
 
A.4.6 - Realistically, what is the fastest start-up time one can expect at your site, from final protocol to first-patient-in (FPI)?
 
A.4.7 - Are there additional issues at your Center relating to electronic medical records, special compliance needs for monitoring, privacy rules that may affect access to data, monitoring time, etc.?
 
 
A.5 Miscellaneous
 
A.5.1 - List the major genetic testing sites that are used by subjects/families who are seen at your institution.
 
A.5.2 - What makes you an attractive site for HD clinical trials?

Technical / Equipment Information
 
B.1 Does the site have
 
B.1.1 - Access to dedicated clinical space available for research?
 
B.1.2 - Access to computer equipment with high-speed internet access for web-based electronic data capture?
 
B.1.3 - Access to hospital/clinic Electronic Medical Record?
 
B.1.4 - Access to ECG machine?
 
B.1.5 - Access to refrigerated centrifuge for spinning blood?
 
B.1.6 - Refrigerators for biological sample storage?
 
B.1.7 - Access to -80C freezer?
 
 
B.1.8 - Access to -20C freezer?
 
 
B.1.9 - An area for sponsor monitors to review medical records and CRFs?
 
B.1.10 - Adequate, locked storage space for storing study records?
 
 
B.1.11 - Access to adequate, locked storage space for study drug?
 
B.2 Does the site and staff have experience with the following procedures in clinical trials for neurodegenerative diseases
 
B.2.1 - Administering cognitive testing?
 
B.2.2 - Administering psychophysiologic testing?
 
 
B.2.3 - Collection and processing of CSF?
 
B.2.4 - Use of saccadometry in clinical studies?
 
B.2.5 - Acquisition and analysis of MRI Imaging?
 
B.2.6 - Acquisition and analysis of fMRI Imaging?
 
B.2.7 - Acquisition and analysis of Diffusion Tensor MR Imaging?
 
B.2.8 - Acquisition and analysis of PET Imaging?
 
 
B.2.9 - Acquisition and analysis of SPECT Imaging?
 
 
B.2.10 - Do you have access to 1.5T MRI for research purposes?
 
 
B.2.11 - Do you have access to 3T MRI for research purposes?
 
 
B.2.12 - Do you have access to 7T MRI for research purposes?
 
 
B.2.13 - Do you have access to any other MRIs?
 
 
B.2.14 - Ability to do both computer-assisted and paper/pencil cognitive testing?
 
B.2.15 - Do you have access at your institution to a Sleep Lab?
 
B.2.16 - Does your site have experience using electronic data capture (EDC) for clinical trials?
 
 
B.2.17 - If imaging (e.g. MRI, PET, SPECT) were part of a clinical trial, is your site capable of transferring digital images to a FTP server or a WEB-based system (directly via PACS or local storage media, e.g. CD)?
 
 
B.2.18 - Does your center have full-time IT support for your systems?
 
B.2.19 - Is the appropriate emergency medical equipment for intervention and safety monitoring in place?
 
B.2.20 - For participants who may be suicidal does the site have a procedure in place for appropriate crisis intervention?
 

Additional Information
 
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By submitting information to GSID-HD, you hereby grant a non-exclusive, irrevocable, royalty-free license to all such information under the Creative Commons Attribution 3.0 License - Attribution-Share Alike (http://creativecommons.org/licenses/by-sa/3.0/us/legalcode) to any person who agrees to use such information only for the purpose of planning HD research.