NXDC IIT Form Dear Healthcare Provider,Thank you for your interest in studying Gleolan at your institution. In order to begin our review process, please complete and submit this form to Kelli Hill, NXDC IIT Coordinator at khill@nxdevcorp.com. Once we receive your study information, our IIT Review Committee will evaluate and provide feedback to the contact person listed on this form. Feedback can be expected 2-4 weeks after receipt of this form. 1. Principal Investigator:Name*Email Address* Phone Number*Street Address*City*State*Please select stateAlabamaAlaskaArizonaArkansasCaliforniaColoradoConnecticutDelawareDistrict of ColumbiaFloridaGeorgiaHawaiiIdahoIllinoisIndianaIowaKansasKentuckyLouisianaMaineMarylandMassachusettsMichiganMinnesotaMississippiMissouriMontanaNebraskaNevadaNew HampshireNew JerseyNew MexicoNew YorkNorth CarolinaNorth DakotaOhioOklahomaOregonPennsylvaniaRhode IslandSouth CarolinaSouth DakotaTennesseeTexasUtahVermontVirginiaWashingtonWest VirginiaWisconsinWyomingArmed Forces AmericasArmed Forces EuropeArmed Forces PacificZip*2. Multi-Center Trial*2. Multi-Center Trial*YesNoAnticipated Participating Sites (please list all) 3. Concept InformationConcept Title*Primary Objective(s)* Secondary Objective(s)* Study Type*Statistical Plan*Proposed sample size*4. Type of SupportType of Support:* Drug FinancialSupport provided by other Companies?*NoYes (specify)Specify*5. Study Design and Rationalea) Background Information on Disease State and Protocol Rationale. Also indicate if you currently have access to a blue light surgical microscope/endoscope.*b) Study Design*RandomizedNon-RandomizedSingle-arm studyc) Study Description*d) Scientific Rationale*6. Study Populationa) Disease and population to be studied*b) Inclusion Criteria:* b) Exclusion Criteria:* 7. IND Determination (21 CFR Part 312)Will this study require filing for an IND (US studies only)*YesNoDoes this study meet the criteria below for IND exemption status?*YesNoN/A (specify)Specify*I. The investigation is not intended to be reported to the FDA as a well-controlled study in support of a new indication for use nor intended to be used to support any other significant change in the labeling for the drug;II. If the drug that is undergoing investigation is lawfully marketed as a prescription drug product, the investigation is not intended to support a significant change in the advertising for the product;III. The investigation does not involve a route of administration or dosage level or use in a patient population or other factor that significantly increased the risk (or decreases the acceptability of the risks) associated with the use of the drug product;IV. The investigation is conducted in compliance with the requirements for institutional review set forth in 21 CFR Part 56 and with the requirements for informed consent set forth in 21 CFR Part 50; andV. The investigation is conducted in compliance with the requirements of 21 CFR Part 312.7.8. Publication PlanAll studies are expected to follow clinicaltrials.gov registration laws as specified by US Public Law 110-85, Title VIII, Section 801 (https://clinicaltrials.gov/ct2/manage-recs/fdaaa) and ICMJE requirements (http://www.icmje.org) for disclosure and publication of protocol and results.Intended Journal Submission*Intended Manuscript Title*CommentsThis field is for validation purposes and should be left unchanged. V 1.0 April 2020
