Investigational New Animal Drugs (INADs) University - Junior Level

Junior Level:  This material covers more advanced questions regarding data entry, how to properly complete the Results Report, and which species can be treated under an INAD.

Subject 1: Results Report

  • When is the data due?

    Study result forms are due 30 days after the last day of treatment. Some INADs require mortality data to be collected for 10 days post-treatment, laboratory tests to be conducted and included in the results (i.e., ELISA tests), or post-hatch evaluation of progeny; in those circumstances we ask that you submit the study Result Report no later than 30 days after all data has been collected.


  • How do I close out a study that wasn’t conducted, and are studies ever removed from the database?

    To close out a study that was not conducted; click on the study from the investigator’s account and select “No” from the “Was Treatment Initiated” banner located at the top of the page. Provide a reason for why the study was not conducted and click “Save Changes” at the bottom of the form.

    Please be aware that studies will never be removed from the database, even if they are closed out, as we are required to keep records of all studies regardless of whether they are initiated.


  • What happens if I lose my data and can’t complete the data entry?

    If data is lost, you are still required to complete the Results Report by providing your best estimates for all the required fields. Please provide the reasoning for why true data was not reported in the “Description of Results” section as well as the “Study Deviation” section in the Results Report.


  • What happens if I don’t turn my data in?

    If you do not report your data in a timely fashion, AADAP will contact you. If you do not respond and your data is not submitted by the end of the year, AADAP will complete the form using estimates. Your facility will then be removed from the INAD Program and will no longer be allowed to participate in the program. Such facilities will be reported to the FDA and to the drug sponsor.

Subject 2: Study deviations

  • What is considered a deviation?

    Any changes from the FDA approved study protocol are considered deviations and need to be reported in the “Study Deviation” section on the Results Report.

    Example: The number of treatment days in your study differs from what is allowed in the protocol.


  • What happens if I need to deviate from the protocol?

    If you know that a deviation will occur, contact your monitor and AADAP before initiating treatment. We will ensure that the FDA’s protocol is largely being followed. Some deviations will require AADAP to contact the FDA and ask for permission. If a deviation is found after treatment has occurred, this needs to be reported to the monitor and AADAP as soon as possible, as well as documented in the Results Report form.


  • How soon after treatment can I retreat my fish?

    Contact AADAP if you are interested in concomitant use, as some INADs allow this. However, most INADs cannot be paired with other drugs (approved or unapproved). This enables us to ensure that we can adequately determine the effectiveness of individual drugs.


  • Can I treat with multiple drugs at the same time (concomitant use)?

    First check the protocol to make sure re-treatments are allowed. If they are, you must wait at least 14 days between INAD treatments. If your fish will not survive without immediate treatment, contact AADAP. If fish are re-treated before the 14-day period, a deviation will need to be reported in the “Study Deviation” section in the Results Report.

Subject 3: Special circumstances

  • Can other animals besides fish be used under AADAP’s INADs?

    AADAP can only allow use of our INADs on aquatic animals that are listed in the FDA Food Use Authorization letter. Fish are the focus of most of AADAP’s INAD use. However, certain INADs have been used to treat shrimp, lobster, mussels, oysters, and sharks. Please contact AADAP if you’re interested in treating a species not listed in the INAD’s protocol.


  • What if the species I want to treat is threatened or endangered?

    If you are working with a federally listed threatened or endangered species, you need to use either an INAD or an approved drug for treatment. If you need to use a drug that is not an INAD or is unapproved, contact AADAP for more information.

  • Will treating fish with an INAD make them harmful to consume?

    All INADs have been reviewed by the FDA and assigned a withdrawal period which must be maintained before the treated fish can be released. The withdrawal period ensures that if captured, treated fish would be safe for human consumption. If a withdrawal period is not listed in the protocol, then fish treated with the INAD cannot be used for human consumption. This is another reason why carefully reading through the study protocol prior to initiating treatment is important.





Story Tags

Work of the Service