1Including but not limited to: Alzheimer’s disease, adult ADHD, circadian rhythm disorder, delirium, diabetes, epilepsy, fatigue, hypertension, major depressive disorder, migraine, multiple sclerosis, nocturia, oncology, panic disorder, Parkinson’s disease, perimenopausal disorders, PTSD, and shift work disorder.
2outpatient, inpatient, long-term care
Note: BELSOMRA® has been designated by the US DEA as a Schedule IV Controlled Substance. US Investigator initiated study sites and site personnel must provide proof of Federal Registration and State Licensure. All study sites must have standard operating procedures in place for compliance with all applicable controlled substance laws and regulations Please complete a protocol with detailed budget via Visiontracker, the Company's on-line study management system (in US) or your MSD country representative (outside US). The protocols will be collectively reviewed and selected by the Insomnia MISP Committee. Critical Activities and Timelines:Activity | 1stReview Cycle | 2ndReview Cycle | 3rdReview Cycle | 4thReview Cycle |
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Protocol Submission / Detailed Budget | March 9, 2022 | May 19, 2022 | August 18, 2022 | November 17, 2022 |
Support Material
iEnvision-Visiontracker Site
Applicant Guide
Video: Global Clinical Budget Completion
Instructions: Correlative Data Entry
General Medicine | Infectious Diseases | Vaccines
Preclinical Protocol Template
Preclinical Budget Template
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Clinical Protocol Template---------------------------------------------------
Material Transfer Protocol Template (Compound Only, No Funding)Oncology MISP
Clinical Concept Summary (funding cycle only)
Preclinical Concept Summary (funding cycle only)
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Clinical Proposal Template---------------------------------------------------
Pembrolizumab Protocol Template (restricted)---------------------------------------------------
Clinical Budget TemplateOncology Translational Studies Program
OTSP Summary Template
MISP Contacts
Information