HD Clinical Trial Site Certification

 

 

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Huntington Disease Clinical Trial Site Certification Scheme

**Click here to apply** 

Huntington Disease (HD) Clinical Trial Site Certification 

HD Clinical Trial Site Certification is an initiative of the Huntington Disease Clinical Trials Task Force (HD-CTTF, http://www.hd-trials.info), a group of international experts in HD clinical and scientific research. The HD-CTTF works in collaboration with CHDI and EHDN, and has open access to the Registry and Enroll-HD platforms and participant databases.

Certification is based on a clearly visible set of industry-agreed, minimum generic clinical trial criteria that sites must meet to be classified as a certified HD clinical trial site and to be presented to HD clinical trial sponsors by the HD-CTTF for potential inclusion in EHDN endorsed clinical trials. All certified sites therefore have the potential to be included in the selection process for future clinical trials.

Certification is open to all sites in the HD-CTTF’s regions of activity: Australia, Europe, Latin America, North America, New Zealand, Nordic regions and Russia.

Background

With an increasing number of drugs coming through the development pipeline, there are expected to be multiple concurrent clinical trials in HD. Currently a relatively small pool of sites are involved in HD trials, leaving little scope for expansion of recruitment capability. For clinical sites, the processes surrounding site identification and selection can be unclear, and the selection process can be inefficient, with sites providing similar information to multiple parties using traditional feasibility assessment methods.

The certification scheme aims to improve the site selection process and maximise the number of high-quality trial-ready sites.  The scheme reduces the administrative burden for sites during trial set-up by centrally storing information about site feasibility, training, and qualifications and providing details of sites to approved Sponsors. It will provide an opportunity to increase the visibility of potential trial sites and provide guidance and support for less experienced sites to become trial-ready.

What is HD Clinical Trial Site Certification?

The scheme will assess HD clinical trial sites with a wide variety of clinical trial experience providing they meet the necessary pre-defined criteria.

Certification requires that sites meet a specific set of criteria designed to assess clinical trial capability and performance, including general site information, clinical trial infrastructure, patient cohort, training and education. For a full list of criteria, see below.

Certification Criteria

A pre-requisite for certification is the completion (or update) of the Global Site Investigator Database (GSID-HD).

The below criteria must also be fulfilled for a site to become certified.

  • At least 30 HD participants, or access to 30 HD patients, in Enroll-HD/Registry, or local database (for non Enroll-HD/Registry sites).
  • Good quality data (no significant audit or quality findings)
  • A MD on the study team who can act as PI for trials
  • Staff trained in HD-specific assessments (PBA-s and UHDRS motor): at least one trained rater for each assessment.
  • A dedicated study coordinator for trials
  • GCP training within the last 3 years for clinical trial staff
  • Facilities: patient assessment, secure clinical data and IMP storage areas, space for monitoring, high speed internet access
  • SOPs: Informed Consent, IMP procedures, Handling Medical Emergencies
  • Clinical trial staff (minimum PI and SC) fluent in English language

What are the benefits?

  • Reduce the administrative burden for sites during trial set-up by centrally storing information about feasibility, training, and qualifications.
  • Increase chance of participation in clinical trials (certified sites may be recommended as potential trial sites and could be further assessed for feasibility for specific studies)
  • Increase site knowledge of clinical trial management procedures and provide access to guidance.
  • Participation in an international network of HD clinical trial and research centres.
  • Increase profile as a certified Huntington’s disease Clinical Trial site among patients, health care providers, clinicians, industry and academic partners

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How to apply

Applications are open to all HD clinical research sites within the HD-CTTF regions defined above.

Global Site Investigator Database (GSID-HD)

  • The GSID must be completed for the site applying for certification. The GSID captures extensive site information for feasibility assessment. GSID responses will be used to support the application for certification and assess feasibility for clinical trials so it is important that the information is accurate and complete.
  • Enter all HD clinical team members in GSID-HD.
  • If no GSID-HD entry exists, to open a new account, go to: http://qbagent.chdifoundation.org/Android/Public/submitGSIDSiteAdd.php.
  • For assistance with completing the GSID-HD, or if you cannot access an existing account please contact gsid@enroll-hd.org.

 Application form

 Documentation

Submit required documentation to hdsite@euro-hd.net

  • CVs and GCP certificates (GCP training completed within last 3 years) for:
    • Principal Investigator (PI)
    • Study Coordinator (SC) and
    • one rater if there are additional rater(s) at the site who differ from the PI/SC

If GCP training has been completed via the Enroll-HD training platform (https://hdtraining.enroll-hd.org), or GCP documentation/CVs have been uploaded there, there is no need to resubmit. Inform the application team that they are located here and they can be accessed centrally.

 

  • Standard Operating Procedures (SOPs)
    • Informed consent
    • Handling of study drug (i.e. receipt, storage, dispensing, accountability)
    • Handling of medical and psychiatric emergencies (including any assessment/referral procedures for suicidal participants).

If SOPs are lengthy or there are multiple SOPs that cover one of the above requirements (e.g. Pharmacy SOPs), it is permissible to only submit the table of contents or index of SOPs.

If no SOPs are currently in use at a site, the HD-CTTF will send template SOPs that can be adapted for local use. These must be implemented within 6 months of the date of certification, and a copy returned to hdsite@euro-hd.net

Applications will be reviewed when the application form and GSID-HD is complete and all required documentation has been submitted.

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How are eligibility criteria verified?

Applications are verified remotely using information provided in GSID-HD, CVs, Enroll-HD and EHDN training records and available quality metrics.  Following remote review, sites that meet all criteria will be awarded certification by the HD-CTTF (within 1 month of validated submission of a completed application). Certification will be annually renewable, via a re-application process involving review of any changes impacting site eligibility.

In addition, a complete on-site spot-check audit of the certification eligibility criteria will be undertaken for all sites during routine Enroll-HD monitoring visits (for non-Enroll-HD sites, alternative arrangements will be made).

Certification is not dependent on on-site review, however a failure to demonstrate the required criteria at the site visit would result in a review of eligibility, and suspension of certification if necessary.

The HD-CTTF maintains records and associated audits and manages renewal and any necessary suspensions of certification.

 

How is information about certified sites accessed?

Site information can only be requested via the HD-CTTF, by authorised clinical trial sponsors.

For any questions about site certification, please contact hdsite@euro-hd.net.