Master Clinical Trial Agreement - HEALEY ALS Platform Trial

Project: Research project

Project Details

Description

The Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital (“MGH”) has established the HEALEY ALS Platform Trial to expedite the investigation of therapies that show promise in Amyotrophic Lateral Sclerosis (“ALS”). Platform trials are an innovative approach to trial design that enable concurrent testing of multiple drugs under one protocol (“Master Protocol”).

For each Study Regimen to be tested under the Master Protocol, MGH shall issue a Task Order under this Agreement. Each Task Order shall provide Site the additional detail not otherwise covered under this Agreement – including the budget and funding source specific to that investigational product, as well as a Regimen-Specific Appendix to the Master Protocol (“RSA”) that amends the Master Protocol with information specific to the investigational product (if any).

Site will be responsible for recruiting and enrolling study subjects for participation. Informed consent will be obtained for each participant. Once informed consent has been obtained, Site will be responsible for scheduling and performing all study visits and submitting all data via the Electronic Data Capture (“EDC”) system.
StatusActive
Effective start/end date12/5/1912/4/24

Funding

  • Massachusetts General Hospital (Agmt 12/5/19)

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