
One of the ways HSG fulfills the organization’s mission of accelerating treatments that make a difference is by designing and executing world-leading clinical trials for Huntington’s disease (HD). To support this research, HSG has developed policies and processes to ensure all Investigators, Coordinators, and Sites who are interested in participating in trials run by HSG meet specific criteria and standards of excellence. To learn more about eligibility or to apply to become credentialed by HSG, please review the information below.
Before filling out an application, please read through it and make sure you have all required elements ready to submit at one time. This application is not a “save as you go” process, so please be sure you have your necessary documents ready to upload when you complete your application.
Credentialing Requirements
Investigator
- Must have experience as a Principal Investigator or Sub-Investigator in a clinical trial.
- Please note: If it is found that the applicant does not have sufficient clinical trial or HD clinical care experience, additional training suggestions will be recommended to the applicant.
- Must have good standing tenure at an established site with the infrastructure necessary to run an HSG trial.
- Must possess one of the following Degrees: MD, PhD, NP, DO, PA (see below for non-physician policy and application).
- You will be asked to provide General Information, Site Information, Experience and Training on the application form.
- Please gather the required documentation first and then follow the link to the application form.
- Must have completed the CME4HD lecture series training (in-person or online).
- If you have not yet completed the CME4HD, please indicate this on your application and instructions will be provided to you.
- The following materials must be uploaded with the application form:
- Signed HSG Conflict of Interest Statement
- Current CV (signed within the last year)
- Letter(s) of Support (LOS), on institutional letterhead from an HSG Investigator or Mentor
- Current Medical Professional License
- Human Subject Protection Program certificate(s) – PHRP Online Training or Collaborative Institutional Training Initiative (CITI) Program or the equivalent
- Good Clinical Practice (GCP) training certificate- NDAT CTN Training, CITI Program or the equivalent
- Evidence of UHDRS® training and have completed a minimum of 25 UHDRS® assessments (the UHDRS® certification is provided and hosted by Enroll-HD).
- (Optional) required if seeking to perform other assessments: Evidence of certification in additional assessments (CAB, Q Motor, PBA)
- (Optional) Recent professional head-shot photo
- There must be a designated backup physician at the site. All backup physicians must agree in writing to serve in the capacity and attest to the following:
- Acceptance of responsibility for direct medical supervision
- Must be personally in current good standing with any federally regulated requirements for the conduct of clinical trials.
- Must submit his/her credentials to HSG for review if not currently an HSG credentialed Investigator.
- Willingness to abide by the HSG confidentiality and conflict of interest policies for the study under which he/she serves.
- The required letter must be signed and on their institution’s letterhead, addressed to HSG, and submitted with the application materials. This can be included in the LOS, if being written by the same individual.
Coordinator
Coordinators wishing to apply for HSG credentialing:
- Must have experience as a Study Coordinator in a clinical trial.
- Please note: If it is found that the applicant does not have sufficient clinical trial or HD clinical care experience, additional training suggestions will be recommended to the applicant.
- Proof of professional license (if applicable) and/or affiliation with institution is in good standing.
- You will be asked to provide General Information, Site Information, Experience and Training on the application form.
- Please gather the required documentation first and then follow the link to the application form.
- Must have completed the CME4HD lecture series training (in-person or online).
- If you have not yet completed the CME4HD, please indicate this on your application and instructions will be provided to you.
- The following materials must be uploaded with the application form:
- Signed HSG Conflict of Interest Statement
- Current CV (signed within the last year)
- Letter(s) of Support (LOS), on institutional letterhead from an HSG Investigator or Mentor
- Human Subject Protection Program certificate(s) – PHRP Online Training or Collaborative Institutional Training Initiative (CITI) Program or the equivalent
- Good Clinical Practice (GCP) training certificate- NDAT CTN Training, CITI Program or the equivalent
- (Optional) required if seeking to perform other assessments: Evidence of certification in additional assessments (CAB, Q Motor, PBA)
- (Optional) Recent professional head-shot photo
Site Credentialing
- You will be asked to provide General Information, Site and Staff Information on the application form.
- Please gather the required documentation first and then follow the link to the application form.
- To be a credentialed HSG Site, the site must have a Credentialed Principal Investigator and Study Coordinator.
- Site Letter of Agreement
For Transfer
Have you moved to a new site? Please submit a Transfer application if you are a Credentialed Investigator or Coordinator who has moved to a new site. If you have moved to a new site that is not an HSG Credentialed Site, please submit a New Site Application.
- The relocation should be in good standing.
- You will be asked to provide General Information, Site and Staff Information on the application form.
- Please gather the required documentation first and then follow the link to the application form.
- Current CV (signed within the last year)
- Current Medical Professional License, if applicable
- Letter(s) of Support (LOS), on institutional letterhead from an HSG Investigator or Mentor
For Site Update
Please keep us updated! Credentialed HSG Investigators are requested to complete an HSG Site Update form every three years, or sooner if needed.
- Site Investigators will be contacted by email requesting the completion of the form.
- You will be asked for updated contact information and site information on the Site Update form.
- Please gather the required documentation first and then follow the link to the application form.
If you have additional questions about how to become HSG credentialed, please contact:
Huntington Study Group
Phone: 800-487-7671
E-mail: info@hsglimited.org