INVESTIGATOR-INITIATED STUDY Application Form
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STRONGBRIDGE BIOPHARMA
INVESTIGATOR-INITIATED STUDY APPLICATION FORM
PRINCIPAL INVESTIGATOR INFORMATION Legal name: Date of application:
Contact name: Phone:
Email:
Address:
STUDY INFORMATION PLEASE ATTACH A COPY OF YOUR FULL STUDY PROPOSAL Study Title:
Therapeutic Area: Study Hypothesis: Primary and Secondary Objectives:
TA 1
TA 2
TA 3
TA 4
Other: ______Support Requested Please include the type of support, product and/or financial support, including amount/quantities for products.
Estimated total study budget Please attached a detailed line-item budget
State estimated timeline for study completion Please include all phases (initiation, recruitment/enrollment, etc.).
List of attachments to this application (CVs, protocol, budget, IRB approval, etc.):
Additional Information Relevant to this Proposal:
Signature of Principal Investigator: Date:
SECTION BELOW IS FOR INTERNAL USE ONLY GRANT COMMITTEE REVIEW Date Reviewed: COMMITTEE DECISION: APPROVE DECLINE HOLD
Name and signature of Chief Medical Officer: Reviewer Decision: APPROVE DECLINE HOLD
Name and signature of TITLE/POSITION: Reviewer Decision: APPROVE DECLINE HOLD
Name and signature of TITLE/POSITION: Reviewer Decision: APPROVE DECLINE HOLD
Name and signature of TITLE/POSITION: Reviewer Decision: APPROVE DECLINE HOLD
STRONGBRIDGE BIOPHARMA: Investigator-Inititated Study Application Form Page 1 Version 2: June 2016