I Understand That I Have a Right of Access to My Information and Can Correct Or Update

/ Investigator Initiated Study (IIS) Concept Proposal Form
UCB Medical Affairs
Investigator Initiated Study (IIS) Concept Proposal Form
Review cannot be processed unless all fields are addressed / LEAVE BLANK—FOR INTERNAL USE ONLY
CONCEPT TITLE
APPLICANT’S NAME (Last, first, middle) / DEGREE(S)
POSITION TITLE / MAILING ADDRESS (Street, city, state, zip code)
INSTITUTION
CONTACT INFORMATION
TEL:
FAX:
E-MAIL:
THERAPEUTIC AREA:
IMMUNOLOGY
CNS
OTHER (please specify)
TYPE of SUPPORT REQUESTED:
UCB PRODUCT ONLY
FUNDING ONLY
FUNDING & UCB PRODUCT / UCB PRODUCT REQUESTED:
LACOSAMIDE (VIMPAT®)
ROTIGOTINE (NEUPRO®)
CERTOLIZUMAB PEGOL (CIMZIA®)
NOT APPLICABLE
OTHER (please specify)
DISEASE STATE:
Epilepsy Crohn’s Disease
Restless Legs Syndrome Rheumatoid
Arthritis
Parkinson’s Disease
Other (please specify) / STUDY TYPE:
Prospective Retrospective
Health Outcomes Research
Clinical Pre Clinical
Interventional In vivo
Non Interventional In vitro
SUMMARY OF RESEARCH ACTIVITIES. Describe objectives, background, hypothesis, study design, population, specific assessment tools, procedures, length of study, and number of potential subjects. Specify primary and secondary endpoints.
OBJECTIVES
BACKGROUND
HYPOTHESIS
STUDY DESIGN
POPULATION & NUMBER OF POTENTIAL SUBJECTS
ASSESSMENT TOOLS & PROCEDURES
LENGTH OF STUDY
PRIMARY ENDPOINTS
SECONDARY ENDPOINTS
Please submit the completed IIS Concept Proposal Form and Primary Investigator’s CV to:

I understand that UCB will collect relevant personnel information in connection with this proposal including, for example, my contact details and curriculum vitae/resume. I agree that UCB may share this information with other UCB entities worldwide during the evaluation of this application.
I understand that I have a right of access to my information and can correct or update my information by notifying UCB at the following address: .
I understand that this information will remain on file for six years from the end of the study, if the proposal is accepted for support, or two years following its last update by me, whichever is the longer period.
I understand that UCB in consideration of support of the IIS generally requests the unlimited right to practice any intellectual property resulting from this IIS without any further financial or other compensation. I agree to this condition and have received confirmation from the responsible legal advisor of the Hospital/University/Institution that the foregoing condition is also generally acceptable to the Hospital/University/Institution.
I have further been informed that depending on the nature of the IIS and the support, UCB, in rare instances, may also request assignment of certain ownership rights to intellectual property resulting from an IIS to UCB. This will be assessed on the basis of the application for IIS funding. The support and any of the above conditions are subject to mutual agreement in a final contract.
I agree to the above conditions.

APPLICANT’S ACCEPTANCE:
I understand that the implementation of the final study protocol may require submission by me to regulatory authorities as the sponsor for review and approval. All protocols will be conducted in accordance with FDA and ICH guidelines. / SIGNATURE OF APPLICANT / DATE

sop-af-010331 V1.0 (Referenced in sop-008511)

Investigator Initiated Study (IIS) Concept Proposal FormPage 1 of 3