To access operational support for therapeutic studies/trials, sponsors are required to submit a study information package for review by the Enroll-HD Clinical Trial Committee (CTC). The study information package includes:

• Final draft protocol
• Investigator Brochure
• Additional supporting information to justify decisions taken in the protocol
  
  

The Enroll-HD CTC review determines if the therapeutic study/trial can be accepted for platform support.

The review for operational support typically takes 4-6 weeks from the time of submitting the study information package. Ad hoc review meetings may be arranged as necessary.

Protocol amendments following the initial submission must be provided to the relevant Enroll-HD committee for review to ensure continued support.

To access operational support for non-therapeutic studies, sponsors are required to submit a study information package for review by the Enroll-HD Scientific Oversight Committee (SOC). The study information package includes:

• Final draft protocol
• Completed Enroll-HD SOC proposal application
• PI CV
• Relevant supporting material (e.g., draft participant questionnaires, assessment scales)

The Enroll-HD SOC review determines if the non-therapeutic study/trial can be accepted for platform support.

The review for operational support typically takes 4 weeks from the time of submitting the study information package. Ad hoc review meetings may be arranged as necessary.

Protocol amendments following the initial submission must be provided to the relevant Enroll-HD committee for review to ensure continued support.