Guidance for Completing the Drug Section
Note: The use of the name "drug" may also refer to biologics, food or dietary supplements.
Study Scope Page
Does the study use an approved drug or biologic, use an unapproved drug or biologic, or use a food or dietary supplement to prevent, diagnose, cure, treat, or mitigate a disease or condition?
- If the study involves the use and/or evaluation of a drug or biologic (and in some cases food/dietary supplements), this question must be answered “Yes.” Answering “Yes” will display an additional page later in the application so appropriate information can be included for review.
Note: Use means the protocol requires one or more subjects to use the drug, biologic, food or dietary supplement as part of study participation, regardless of whether its use is considered standard of care.
Does your research protocol involve the evaluation or use of procedures that emit ionizing radiation?
If the study involves the evaluation and/or use of a diagnostic radioactive drug or procedure(s) that emit ionizing radiation (including a therapeutic procedure that is NOT consistent with standard of care practice), this question must be answered “Yes.” It is important to review the HUSC Human Use Guidance at to determine the requirements for review.
- If review is required, the HUSC Form 1001 should be downloaded, completed and uploaded in PittPRO in the Local Supporting Documents section.
List all drugs, biologics, foods, and dietary supplements to be used in the study.
Click "Add" to enter the information related to the drug/biologic being used in this study. If there is more than one drug/biologic being used, click the “Add” button to create separate entries for each drug/biologic.
- Select the drug: Perform a search by typing the name, first few letters of the drug, or click on the ellipsis (...) to view the entire list (can also search by generic or brand name). If the drug is not contained in the drop-down menu, type in the generic name and, if known, the brand name.
- Purpose of their use: Provide information related to the reason the drug is being used or evaluated in this study. Example:The drug is being used to determine if there is any improvement in elevated glucose level in patients who are pre-diabetic.
To complete this section, first determine whether the drug is FDA approved for the indication being used in this study. Drugs are routinely used "off label" for clinical care but would be considered unapproved for research purposes. Perform a search of the FDA Online Label Repository or contact your Pharmacy to aid in making this determination. If no package label is found, then presumably there is no current approved indication. If a package label is located, review the "Indications and Usage" to verify the approved patient population, route of administration, and dose.
FDA Status Choices
Meets current FDA approved indication and usage labeling
Select this option if the study will use or evaluate a drug within the currently approved patient population, approved route of administration, and approved dosing. In this case, no IND will be required.
Approved drug or biologic being evaluated for a new indication, population, route of administration, or dosage level not specified in the FDA approved labeling
Select this option if the study will use or evaluate an approved drug/biologic outside of the approved package label (a different patient population, a different route of administration, or a different dose). Two additional questions will be displayed as noted below to determine if the study will need to be conducted under an IND. Refer to IND Determination for specific guidance on this topic.
Unapproved drug or biologic
Select this option if the study will use or evaluate a drug/biologic that has no current FDA approved indication. In this case, an IND will be required.
Attach Files Related to this Drug
- Documents should include items such as the FDA-approved package label or Investigator’s Brochure (IB). If an IB is available for the drug, attach as it contains the most comprehensive data on an investigational drug.
Will the study be conducted under an investigational new drug application (IND) and/or require review by the Human Use Subcommittee (HUSC) of the University of Pittsburgh Radiation Safety Committee?
- If “Yes,” click on the “Add” button to enter information related to the IND and/or HUSC.
IND and/or HUSC Number
- Enter the assigned IND number as listed on the cover page of the protocol document or the FDA acknowledgment letter. Enter [HUSC # (for modifications previously reviewed by HUSC vs TBD for new HUSC submissions].
Who will serve as the Sponsor for this IND?
|Select Commercial/Industry Sponsor if a corporate company such as a drug manufacturer or CRO will act as sponsor of the IND Application||N/A|
|University of Pittsburgh/UPMC Investigator||Select University of Pittsburgh/UPMC Investigator if a University faculty member or UPMC clinician will act as sponsor of the IND Application||Select University of Pittsburgh/UPMC Investigator as the holder of the HUSC|
|Other||Select Other if the IND sponsor is not commercial/industry or a Pitt/UPMC investigator||N/A|
Notes regarding this chart:
1. Sponsor means a person who takes responsibility for and initiates a clinical investigation. The sponsor may be an individual or pharmaceutical company, governmental agency, academic institution, private organization, or other organization. In this instance, sponsor does not mean the source of financial support. It is critically important to select the correct choice as to avoid a delay in review.
2. If the clinical trial is externally sponsored, the clinical trial documents provided by the sponsor should clearly indicate whether it is being conducted under an IND.
Upload files not related to a specific drug or not already uploaded elsewhere. Examples include a justification for why an IND is not required, FDA’s IND Acknowledgement Letter, or confirmation receipt of submission to FDA.