Supplemental IRB Form: Drugs and Biologics



Supplemental IRB Form: Drugs and BiologicsSubmit this form with the IRB Research Proposal Document to IRBaccess if the study involves use of drugs or biologics.Study NumberClick or tap here to enter text.Drug InformationIdentify all drugs/biologics to be used in this study. Complete one table for each drug:Additional tables may be generated by clicking the + button to the right of the row while its contents are selected. Click in the table below to access the Repeating Section Content Control.Drug NameClick or tap here to enter text.ManufacturerClick or tap here to enter text.Drug CategorySelect all that apply?FDA approved for this use?Investigational drugUpload Investigator Brochure?Over the counter medication?Supplement?Drug or compound with other status:Click or tap here to enter text.Dosing information?Dosing will match FDA approved labelling. STOP – If dosing will match FDA approved labelling skip this section and complete IND Application Exemptions for Studies using Drugs or Biological Product section below?Dosing will not match FDA approved labelling. Provide all doses and dosing schedules if deviating from FDA approved labelingClick or tap here to enter text.?N/A - No FDA approved dosage.Investigational New Drug (IND) Information If not applicable skip to IND Application Exemptions for Studies using Drugs or Biological Products section belowSelect who holds the Investigational New Drug application?External Sponsor or InvestigatorName and title: ?UT Sponsor-InvestigatorName and title: Click here to enter text.Click here to enter text.Drug IND Number: Click or tap here to enter text.Drug storage and transport procedures Describe where the drug(s) will be stored and how they will be dispensed:Click or tap here to enter text.Who is responsible for drug accountability?Click or tap here to enter text.Drug Washout Information NoDoes this study require a washout period?If applicable, describe washout procedures and timeline:Click or tap here to enter text.?Subjects withdrawn from study also require washout periodInvestigational New Drug (IND) Application Exemptions for Studies using Drugs or Biological Products The two categories below of clinical investigations are exempt from the IND requirements in part 312, provided the criteria for exemption are met (see 21 CFR 312.2(b) and 320.31(b)). Clinical investigations of drugs that do not meet these criteria must be conducted under an IND. If you do not have an IND, check the criteria below that apply to your study.A. Certain Research Involving Marketed Drug Products - A clinical investigation of a marketed drug is exempt from the IND requirements if all of the criteria for an exemption in § 312.2(b) are met. Check the criteria that apply to this study.?The drug product is lawfully marketed in the United States.? The investigation is not intended to be reported to FDA as a well-controlled study in support of a new indication and there is no intent to use it to support any other significant change in the labeling of the drug.? In the case of a prescription drug, the investigation is not intended to support a significant change in the advertising for the drug.?The investigation does not involve a route of administration, dose, patient population, or other factor that significantly increases the risk (or decreases the acceptability of the risk) associated with the use of the drug product (21 CFR 312.2(b)(1)(iii)).B. Bioavailability (BA) or Bioequivalence (BE) Studies in Humans - BA/BE studies using unapproved versions of approved drug products; which can be conducted without submission of an IND (21 CFR 320.31(b) and (d). A BA/BE study in humans do not require an IND if all of the following conditions are met. Check which conditions apply to this study.?The drug product does not contain a new chemical entity (21 CFR 314.108), is not radioactively labeled, and is not cytotoxic.? The dose (single dose or total daily dose) does not exceed the dose specified in the labeling of the approved version of the drug product.? The investigation is conducted in compliance with the requirements for review by an IRB (21 CFR part 56) and with the requirements for informed consent (21 CFR part 50).?The sponsor meets the requirements for retention of test article samples (21 CFR 320.31(d)(1)) and safety reporting (21 CFR 320.31(d)(3)). ................
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