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Study Hub/Site Resources
Reference library

Documents, training and answers for site teams

Current versions only. When a document is updated, the previous version is removed from this page so that what you download here always matches what is in your site file.

Training and reference

TRAININGGRASSP QtP training and oversightAssessor training and certification for the primary endpoint, refresher sessions, and how central oversight reviews assessments.Training module and guide VIDEOParticipant self-administration videoStep-by-step injection training for participants, with transcript and procedural screenshots.Video, 6 min, with transcript PDFEnrollment and pre-screening tipsReferral sources, handling enquiries from the study mailbox, and scheduling screening and randomization.PDF, 3 pages PDFeCOA and RTSM quick referenceDevice setup, randomization steps and help desk contacts.PDF, 2 pages PDFSafety reporting contacts and timelinesSerious adverse event reporting windows and pharmacovigilance contacts.PDF, 1 page WEBInvestigator Meeting, ChicagoAgenda, logistics and, after the meeting, the presentation materials.Posted after the November meeting

Frequently asked questions

How long should screening take?

Plan for about one week between the screening visit and randomization. The protocol allows more time where it is needed, but scheduling and eligibility review should be arranged so that most participants can be randomized within a week of screening. Eligibility must be fully reviewed before randomization.

Who can perform the GRASSP QtP, and how is it overseen?

The GRASSP Quantitative Prehension is the primary endpoint, so only assessors who have completed the sponsor-provided training and certification may perform it. Central oversight reviews assessments for consistency across sites, and refresher training is available at any time. The training module is listed above; contact your Worldwide Clinical Trials site manager to schedule certification for new assessors.

Who handles IRB submissions for my site?

Worldwide Clinical Trials prepares and submits packages for sites using a local IRB. Sites under the central IRB take no action until an approval is posted.

How do potential participants reach the study?

Enquiries arrive through the study mailbox and through your own referral network. Enquiries that match your location are passed to your site for pre-screening. The enrollment and pre-screening tips document above describes how to triage and schedule them.

Can we share a press release with our institution's communications office?

Yes, once it has been released. Links to each release are kept under Press & Registry. Please refer any press or investor questions about RESTORE to NervGen.

Where will the Investigator Meeting materials be posted?

Here, under Site Resources, after the November meeting in Chicago. Registration and logistics will be sent to each site beforehand and posted under Announcements.

Where do I send a question that is not covered here?

Use the study mailbox, restorestudy@nervgen.com, or contact your Worldwide Clinical Trials site manager. See Contacts.