The term drug may include:
- FDA approved drugs,
- unapproved use of approved drugs,
- investigational drugs or biologics,
- other compounds or products intended to affect structure or function of the body, and/or
- complementary and alternative medicine products such as dietary supplements, substances generally recognized as safe (GRAS) when used to diagnose, cure mitigate, treat or prevent disease, or clinical studies of e-cigarettes examining a potential therapeutic
purpose.
Does this protocol involve a drug including an FDA approved drug; unapproved use of an FDA approved drug; and/or an investigational drug?
Yes/No
If yes, complete the questions below.
Using the "Add Study Drug" tool below, list each drug, biologic, or compound tested in this study - Fields are enabled/disabled based on your responses.
+Add Study Drug
Drug Name: Enter drug name
Is this a combination drug/device product? Yes/No
Study Dose and Route of Administration: Enter information
Does the investigational plan permit does adjustments? Yes/No
Describe or reference protocol: Enter description or reference
Approval Status: FDA Approved or Legally Marketable Product / FDA Approved but testing unapproved use / Not FDA Approved / Unsure
Where will the study drug(s) be housed and managed? Investigational Drug Service (IDS) UK Hospital / Other Location
Describe how drug(s) will be handled including policies and procedures for receipt, storage, control, dispensing, and accountability: Enter description
Investigational New Drug (IND) Applicability
Applicability of IND Regulatory Requirements:
Under FDA regulations, research that involves use of a drug other than the use of a marketed drug in the course of medical practice must have an IND, unless the study meets one of the IND exemptions [21 CFR 312.2(b)].
Complete the following to document that the study is either:
1) Exempt from IND requirements, or
2) Subject to IND requirements and being conducted under a valid IND
Attach any applicable FDA correspondence.
To assist you in determining which category applies to your study, see FDA guidance for determining whether human research studies may be exempt from IND requirements or IND Exemptions for Studies of Lawfully Marketed Drugs or Biological Products for the Treatment of Cancer.
Is the study being conducted under a valid Investigational New Drug (IND) application? Yes/No
If Yes, list IND #(s) and complete the following:
List IND #(s)
IND Submitted/Held by:
- Sponsor Held by: Enter information
- Investigator Held by: Enter information
- Other Held by: Enter information
Checkmark if the study is being conducted under FDA's Expanded Access Program (e.g. Treatment IND) of if this is an Individual Patient Access IND (FDA Form 3926).
View FDA's Expanded Access Program Information for Individual Patient Expanded Access INDs, and attach the following:
- FDA Form 3926;
- FDA expanded access approval or correspondence;
- Confirmation of agreement from manufacturer or entity authorized to provide access to the product.
For guidance and reporting requirements at the conclusion of treatment see the Expanded Access Program for Drugs SOP.
Study is Exempt from IND Requirements
The following are categories of studies that may be “Exempt” from IND requirements. Specific criteria or conditions within each category must be met to qualify for exemption.
Consultation with the FDA may be required at the discretion of the IRB. See FDA contact information below.
Indicate if the drug(s) used in this study meets any of the following IND Exemption categories and attach any available supporting documentation from the FDA or the Sponsor. Specific criteria or conditions within each category must be met to qualify for
exemption from IND requirements. If unsure if a drug used in this study meets an exemption category, you are responsible for consulting category-specific guidance below or checking with the FDA in order to determine whether an IND is required.
Not applicable / Complete following information
I. Study is exclusively collection of clinical outcomes (i.e., real world data) on an approved/cleared drug used in clinical care.
In order to meet this exemption, study must not affect treatment decisions or how the drug is administered. Treatment must be based on medical practitioner's clinical judgment (e.g., case-control study, clinical outcomes registry). This exemption would not apply if gathering data would influence treatment decisions.
II. Study involves an FDA Approved drug product and ALL of the following are true. If ANY of the following statements are “false”, you are responsible for consulting FDA to determine whether an IND is or is not required.
- True/False The drug is lawfully marketed in the United States.
- True/False The results of the investigation are NOT intended to be reported to FDA as a well-controlled study in support of a new indication for use or intended to be used to support any other significant change in the labeling for the drug.
- True/False The investigation is NOT intended to support a significant change in the advertising of a lawfully marketed prescription drug product.
- True/False The investigation does NOT involve a route of administration or dosage level or use in a patient population or other factor that significantly increases the risks (or decreases the acceptability of the risks) associated with the drug product*.
- *The study may involve an unapproved use as long as change does not significantly increase risk or decrease acceptability of risk. For guidance regarding FDA’s interpretation of dose, population, or route of administration changes that may significantly affect risk, see the FDA Guidance regarding determining if research may be conducted without an IND or FDA IND Guidance for Marketed Cancer Treatments.
- True/False The research is conducted in compliance with IRB review (21 CFR 56), informed consent (21 CFR 50), and marketing and promotion limitations described in 21 CFR 312.7.
III. Other Potential Exemption Categories:
Each of the following exemption categories has specific conditions or criteria that must be met in order to qualify for exemption from IND requirements. If the study meets any of the following exemption categories, you are responsible for consulting FDA IND guidance and/or checking with FDA to confirm the specific criteria are met in order to be exempt from IND requirements.
- Testing of select in vitro diagnostic biological products that meet the required conditions (a) it is intended to be used in a diagnostic procedure that confirms the diagnosis made by another, medically established, diagnostic product or procedure and (b) it is
shipped in compliance with § 312.160.
- Select Bioavailability or Bioequivalence Studies (see FDA IND guidance for dose limitations and required conditions).
- Select types of Cold Isotopes (see FDA IND guidance for types and required conditions).
- Dietary supplements, botanicals, or other substances designated as generally recognized as safe (GRAS) may be exempt from FDA IRB and IND regulations if study is intended only to reduce risk of a disease; evaluate effect on structure or function of the body; or support a new or expanded health claim and conducted in healthy individuals over 12 months of age. Studies designed to evaluate a supplement’s ability to diagnose, cure, mitigate, treat or prevent disease are considered to be FDA regulated and are NOT exempt from IND submission requirements. Refer to FDA Guidance Structure/Function Claims, Small Entity Compliance Guide for examples of structure/function effects.
- Electronic nicotine delivery systems (e.g., e-cigarettes) research may not require an IND if testing does NOT involve a therapeutic purpose. A study designed only to evaluate an effect on structure or function in the body may be exempt from IND requirements. An IND would be required if the intent of the study was to evaluate a product’s ability to diagnose, cure, mitigate, treat or prevent disease. If the study examines the product’s ability to cure nicotine addiction, or mitigate withdrawal symptoms, the sponsor investigator should consult with FDA regarding need for an IND. See FDA and NIH Guidance.
IV. If available, attach correspondence from FDA or commercial sponsor indicating that IND is not indicated for this study.
Study Drug Management Accountability, Registration, Training & Qualifications to Administer [21 CFR 312.57]
For applicable clinical trials initiated after March 7, 2012, FDA regulations require the informed consent document to include a specific statement informing subjects about trial registration and availability of trial data on clinicaltrials.gov. If study is registered on
clinicaltrials.gov, do all informed consent documents associated with the study include the specific statement?
Yes/No/N/A (e.g., not an *applicable clinical trial)
Attach applicable drug documentation
(e.g., Sponsor protocol; investigator brochure; approved labeling; indications for use; package insert, and/or drug monograph (e.g., Micromedix, PDR); FDA correspondence (e.g., validation of IND#; FDA Form 3926); contraindications; precautions, warnings; etc.). Attachments here will automatically be assigned the "Other Drug Documentation" document type.
See the ORI FDA Website for FAQs and FDA contact information.
