Drug, Biologic, Nutritional Supplement, & Substance Table Printed on 1/31/2017 10:03:12 AM

Study Short Name:

List any specifically-named drug, biologic, nutritional supplement, substance, or any other ingested/applied substance required by the protocol OR provided/paid for by the sponsor. There is no need to include items merely suggested or recommended unless they are to be paid for by the sponsor. Sponsor-funded pre-meds or concomitant meds obtained from a non-investigational pharmacy can be listed generically as long as you have a Confirmation of Services from the applicable pharmacy that acknowledges that these drugs will be invoiced to the study.

Note: A Confirmation of Services is REQUIRED for any item that is billed to/provided by the Sponsor AND that is stored or administered in a location marked with “*”. Contact Investigational Drug Services at 352-265-0404 Ext. 44716 for more information on both investigational AND non-investigational pharmacies.

Name of Item / Use of Item / FDA Drug Type
(choose from drop down) / FDA IND# / Funding Source
(choose from drop down) / Administration
Location / Storage Location /
All SubjectsConditional / *IDE Catagory A*IDE Catagory B*HUD*PMA (Carotid Artery Stent)PMA (non Carotid Artery Stent)FDA Approved 510 (k) FDA Approved Off Label UseNSR (Non-significant Risk)ExemptOther (see comments below) FDA IND FDA IND ExemptFDA ApprovedBiologic Dietary SupplementOther (see comments below) / Provided by SponsorBilled to Sponsor (thru PI)Billed to Patient/InsurerBilled to UF CRC Other (see comments below) / *Inpatient*Infusion Center*Inpatient and Outpatient*UF CRC (by CRC Staff)UF CRC (by Study Team)OutpatientClinicResearch SpaceN/A: Self-administeredOther (see comments below) / *Shands Investigational Pharmacy*UF CRC Investigational Pharmacy*Non-Investigational Pharmacy Secured Research SpaceClinicCommercial Supply Other (see comments below)
All SubjectsConditional / FDA IND FDA IND ExemptFDA ApprovedBiologic Dietary SupplementOther (see comments below) / Provided by SponsorBilled to Sponsor (thru PI)Billed to Patient/InsurerBilled to UF CRC Other (see comments below) / *Inpatient*Infusion Center*Inpatient and Outpatient*UF CRC (by CRC Staff)UF CRC (by Study Team)OutpatientClinicResearch SpaceN/A: Self-administeredOther (see comments below) / *Shands Investigational Pharmacy*UF CRC Investigational Pharmacy*Non-Investigational Pharmacy Secured Research SpaceClinicCommercial Supply Other (see comments below)
All SubjectsConditional / FDA IND FDA IND ExemptFDA ApprovedBiologic Dietary SupplementOther (see comments below) / Provided by SponsorBilled to Sponsor (thru PI)Billed to Patient/InsurerBilled to UF CRC Other (see comments below) / *Inpatient*Infusion Center*Inpatient and Outpatient*UF CRC (by CRC Staff)UF CRC (by Study Team)OutpatientClinicResearch SpaceN/A: Self-administeredOther (see comments below) / *Shands Investigational Pharmacy*UF CRC Investigational Pharmacy*Non-Investigational Pharmacy Secured Research SpaceClinicCommercial Supply Other (see comments below)
All SubjectsConditional / FDA IND FDA IND ExemptFDA ApprovedBiologic Dietary SupplementOther (see comments below) / Provided by SponsorBilled to Sponsor (thru PI)Billed to Patient/InsurerBilled to UF CRC Other (see comments below) / *Inpatient*Infusion Center*Inpatient and Outpatient*UF CRC (by CRC Staff)UF CRC (by Study Team)OutpatientClinicResearch SpaceN/A: Self-administeredOther (see comments below) / *Shands Investigational Pharmacy*UF CRC Investigational Pharmacy*Non-Investigational Pharmacy Secured Research SpaceClinicCommercial Supply Other (see comments below)
All SubjectsConditional / FDA IND FDA IND ExemptFDA ApprovedBiologic Dietary SupplementOther (see comments below) / Provided by SponsorBilled to Sponsor (thru PI)Billed to Patient/InsurerBilled to UF CRC Other (see comments below) / *Inpatient*Infusion Center*Inpatient and Outpatient*UF CRC (by CRC Staff)UF CRC (by Study Team)OutpatientClinicResearch SpaceN/A: Self-administeredOther (see comments below) / *Shands Investigational Pharmacy*UF CRC Investigational Pharmacy*Non-Investigational Pharmacy Secured Research SpaceClinicCommercial Supply Other (see comments below)
All SubjectsConditional / FDA IND FDA IND ExemptFDA ApprovedBiologic Dietary SupplementOther (see comments below) / Provided by SponsorBilled to Sponsor (thru PI)Billed to Patient/InsurerBilled to UF CRC Other (see comments below) / *Inpatient*Infusion Center*Inpatient and Outpatient*UF CRC (by CRC Staff)UF CRC (by Study Team)OutpatientClinicResearch SpaceN/A: Self-administeredOther (see comments below) / *Shands Investigational Pharmacy*UF CRC Investigational Pharmacy*Non-Investigational Pharmacy Secured Research SpaceClinicCommercial Supply Other (see comments below)
All SubjectsConditional / FDA IND FDA IND ExemptFDA ApprovedBiologic Dietary SupplementOther (see comments below) / Provided by SponsorBilled to Sponsor (thru PI)Billed to Patient/InsurerBilled to UF CRC Other (see comments below) / *Inpatient*Infusion Center*Inpatient and Outpatient*UF CRC (by CRC Staff)UF CRC (by Study Team)OutpatientClinicResearch SpaceN/A: Self-administeredOther (see comments below) / *Shands Investigational Pharmacy*UF CRC Investigational Pharmacy*Non-Investigational Pharmacy Secured Research SpaceClinicCommercial Supply Other (see comments below)
All SubjectsConditional / *IDE Catagory A*IDE Catagory B*HUD*PMA (Carotid Artery Stent)PMA (non Carotid Artery Stent)FDA Approved 510 (k) FDA Approved Off Label UseNSR (Non-significant Risk)ExemptOther (see comments below) FDA IND FDA IND ExemptFDA ApprovedBiologic Dietary SupplementOther (see comments below) / Provided by SponsorBilled to Sponsor (thru PI)Billed to Patient/InsurerBilled to UF CRC Other (see comments below) / *Inpatient*Infusion Center*Inpatient and Outpatient*UF CRC (by CRC Staff)UF CRC (by Study Team)OutpatientClinicResearch SpaceN/A: Self-administeredOther (see comments below) / *Shands Investigational Pharmacy*UF CRC Investigational Pharmacy*Non-Investigational Pharmacy Secured Research SpaceClinicCommercial Supply Other (see comments below)
Use of Item Key: / Conditional: Items required by protocol for SOME subjects in SOME circumstances (e.g. Adverse Event, lab results etc.)
All Subjects: Items required by protocol for ALL subjects ( including items that are randomized.)

Out of space? Unprotect this document and add rows.

Comments:

UF Research Administration & Compliance Page 1 of 1 Version 01/30/17