ࡱ> JLGHI bjbjcTcT 4>>     8W#D: $?4 4       <>XN=˞0h=:4> >X_"0 H\44 j : Clinical Materials Services Unit (CMSU)  Investigational Drug/Device Proposal Request Form Need help? Call (585) 350-3838 Requester name:  FORMTEXT       Date requested:  FORMTEXT       Title:  FORMTEXT       Study Name:  FORMTEXT       Department:  FORMTEXT       Protocol #:  FORMTEXT       Phone number:  FORMTEXT       FAX:  FORMTEXT       Intra-mural Mail Box:  FORMTEXT       Email:  FORMTEXT       Study name and contact information: Principal Investigator:  FORMTEXT       Title:  FORMTEXT       Department:  FORMTEXT       Phone:  FORMTEXT       Email:  FORMTEXT       Study Coordinator:  FORMTEXT       Title:  FORMTEXT       Department:  FORMTEXT       Phone:  FORMTEXT       Email:  FORMTEXT       QUESTIONYESNONUMBERCOMMENTSInvestigational Drug/Device InformationName of Drug or Device:Name:  FORMTEXT      Dosage form of drug or type of Device:Dosage Form or Type of Device:  FORMTEXT      Is the drug a Controlled Substance?If yes, which DEA Schedule? 2,3,4 or 5:  FORMTEXT      Does the investigational drug/device have any special storage requirements (e.g. refrigerated, frozen, light sensitive etc.)?Include Storage specifications:  FORMTEXT      Is the Investigational Drug/Device being purchased or donated by the manufacturer? Include detail on plans for purchase or donation, including manufacturer name:  FORMTEXT      Is the study being conducted under an IND/IDE?Include IND or IDE number:  FORMTEXT      Funding SourceIs this study already funded?If yes, indicate funding source:  FORMTEXT      Is this for a grant submission?If yes, indicate granting mechanism and date of submission:  FORMTEXT      Describe any other funding source:Study Design, Size and Duration InformationIs the study open-label or blinded?Open-label or blinded?  FORMTEXT      Is the study Phase I, II, III or IV?Indicate Phase:  FORMTEXT      # of Sites# of SubjectsDuration of Subject participation:XX weeks or monthsEnrollment Start Date:DateExpected Enrollment Duration:XX months# of Countries:XX List all Countries:NRTXɺpV?(,h^XhR5B*CJ OJQJ^JaJ ph,hD5B*OJQJ\^JmHnHphu2h^Xh:5B*OJQJ\^JmHnHphu2h^XhR5B*OJQJ\^JmHnHphuhR5CJ OJQJ^JaJ #hRhR5CJ OJQJ^JaJ h*L5CJ OJQJ^JaJ h2Eq5CJ OJQJ^JaJ hR5OJQJ^JjhMwh2EqU hMwh2EqB*CJ\aJph3fhMwh2EqB*CJaJph3f RVX  s*0$d%d&d'dNOPQYDgdW*0$d%d&d'dNOPQYDgd/] $^a$gd: $0YDa$gdR0YDgdR0YDgd2Eq $9]9a$gd2Eq   2 4 6 @ B n p йПйmMй32jyhjhR5CJOJQJU^JaJ>jhjhR5CJOJPJQJU^JaJmHnHo(u2jhjhR5CJOJQJU^JaJ/jhjhR5CJU^JaJmHnHu2jhjhR5CJOJQJU^JaJ,jhjhR5CJOJQJU^JaJ#hjhR5CJOJQJ^JaJ:h%FhJF\5B*CJOJQJ\^JaJmHnHphu    6 8 L N P Z \ 鿥kQ2jhjhR5CJOJQJU^JaJ2jahjhR5CJOJQJU^JaJ>jhjhR5CJOJPJQJU^JaJmHnHo(u2jhjhR5CJOJQJU^JaJ#hjhR5CJOJQJ^JaJ/jhjhR5CJU^JaJmHnHu,jhjhR5CJOJQJU^JaJ      ( * , @ ^ ϷϨϖmMϖ>h:5CJOJQJ^JaJ>jhjhR5CJOJPJQJU^JaJmHnHo(u2jhjhR5CJOJQJU^JaJhW5CJOJQJ^JaJ#hjhR5CJOJQJ^JaJh]Q5CJOJQJ^JaJ/jhjhR5CJU^JaJmHnHu,jhjhR5CJOJQJU^JaJ2jIhjhR5CJOJQJU^JaJ^ b d x z |  ֜֍s֜bTB#h/]h~oR5CJOJQJ^JaJhRCJOJQJ^JaJ hjhRCJOJQJ^JaJ2jhjhW5CJOJQJU^JaJhW5CJOJQJ^JaJ>jhjhW5CJOJPJQJU^JaJmHnHo(u2j1hjhW5CJOJQJU^JaJ,jhjhW5CJOJQJU^JaJ#hjhW5CJOJQJ^JaJ  T $0$IfYDa$gdC 80YD^8gda 40YDgd/] & F0YDgd/]gdR   > @ B D X Z \ f h l x z | ˽h˨Ph˨/jhjhRCJOJQJU^JaJ,jhjhRCJU^JaJmHnHu/jhjhRCJOJQJU^JaJ hjhRCJOJQJ^JaJ)jhjhRCJOJQJU^JaJhRCJOJQJ^JaJ hRhRCJOJQJ^JaJ hRh~oRCJOJQJ^JaJ#h*LhR5CJOJQJ^JaJ     * , . 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Dosing schedule (include information about any titration, maintenance etc.):Primary, Secondary Packaging Labeling RequirementsWill primary packaging be required or will the manufacturer provide the investigational product in the appropriate primary closure container system?If primary packaging is required please provide details as to primary packaging configuration requested (e.g. 150 tablets/bottle, 200cc/bottle, 7 days dosing/blister card):  FORMTEXT      If you know what the secondary packaging configuration should entail, please provide that detail, otherwise CMSU will provide some scenarios for consideration.Use of an Interactive Web Response System / Interactive Voice Response System (IWRS/IVRS)Will your study require the use of an IVRS/IWRS?If yes, what system will be used?  FORMTEXT      Will your study require CMSU create scratch-off label treatment disclosures?Returns/Destruction ServicesWill sites be required to return materials to CMSU for accountability and destruction? NOTE: To allow CMSU to provide the most comprehensive proposal possible, please include with this request form the following: A Protocol Synopsis Schedule of Activities. Complete this form and e-mail to  HYPERLINK "mailto:cmsu-bd@ctcc.rochester.edu" cmsu-bd@ctcc.rochester.edu Allow 5-7 business days to receive a full proposal Complex projects may require additional time.      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