Investigational New Animal Drugs (INADs) University - Freshman Level

Freshman Level: This material is intended for new participants looking to learn more about how the INAD Program works or participants that need a quick refresher on some of the basic INAD Program information.

Subject 1: Resources to get started

What is required to participate in the INAD Program?
To participate in the INAD Program you need to create an account with the INAD database, designate two people to act as the investigator and monitor who will be responsible for reporting the data, review the required forms, and ensure that the study protocols laid out by the FDA are followed. You may also need to sign a cooperative agreement form (U.S. Fish and Wildlife Service [USFWS] facilities are exempt). Lastly, all data collected must be submitted to AADAP in a timely manner. Upon signing up for the INAD Program, you will receive a step-by-step guide as to what is expected from you to participate in the INAD Program via email.
Which facilities can participate in the INAD Program?
All U.S. facilities (i.e., state, tribal, federal, university, or private agencies/facilities) are encouraged to participate.
How do I enroll in the INAD Program?
Visit our “How to Enroll in the Investigational New Animal Drug Program” page for step-by-step instructions to set up your account. As part of this enrollment process, each facility will select two individuals (an investigator and a monitor) to be involved in the data collection and data entry process. Further explanations of these study roles are explained at the link above.
Is there a user manual for the online INAD database?
Yes, a manual detailing how to use the online INAD database and complete the forms can be found in the database. To access the manual, log into the INAD database and in the upper right-hand corner of the home page you will see an orange “MANUAL” option.

Subject 2: Enrollment details

How many monitors and investigators can a facility have?
Each facility can only have one monitor and one investigator on their account. Other staff members can act as the investigator and enter information into the forms if needed, but only one person’s contact information can be saved in their account.
How much is the INAD enrollment fee?
Each non-USFWS facility/office will be required to pay $700 to participate in the INAD Program for each INAD they plan to use per year. Participants are not limited to the number of studies conducted or the number of species they can treat using an INAD. This fee covers the program’s administrative costs.
The species I would like to treat is not listed in the drop-down menu for enrollment, what should I do?
If you cannot find the species you wish to treat listed in the drop-down menu, first check the INAD factsheet page to ensure that treatment for the species is available under the INAD. If treatment is allowed for the species but it is not listed, please contact AADAP with the species’ scientific and common names.
Can I quit the INAD Program at any time?
Yes! Enrollment only covers one calendar year and is not automatically renewed each year. If you no longer wish to participate in the program, you do not need to take any steps to terminate your enrollment. Keep in mind, you will be required to complete all documentation for the year of your enrollment.

Subject 3: Required skillsets

How much fish husbandry and fish health knowledge is needed?
Participation in the INAD Program requires an understanding of basic fish health and husbandry, typically acquired through years of experience. Having this knowledge ensures that each participant can properly treat the fish following the INAD protocols and collect the needed information, as well as recognize common fish diseases/pathogens. Working with your monitor or fish health professional for proper diagnosis of any fish disease is encouraged.
What should I do if I am completely new to raising fish?
Please reach out to your local agriculture extension agent for information regarding raising fish and basic fish knowledge before joining the INAD Program. Other potential sources to contact could be local universities/colleges or facilities raising similar species.
What should I do if I don’t know how to calculate the treatment dose?
INADs require calculations to determine correct dosing. AADAP’s Quick Desk Reference Guide to Approved Drugs for Use in Aquaculture can be used to reference dosing and examples. Although it is your responsibility to calculate dosages correctly, when you submit your Study Request through the INAD database we will double check your proposed dose to ensure it is accurate and follows the study protocol. This is why it is important that you submit Study Requests prior to initiating treatment.

Subject 4: Communication

Who should I contact if I have INAD questions?
The first person to contact regarding questions is your monitor, as it is their role to advise you through the required steps to participate in the INAD Program. If your monitor cannot answer your questions, contact AADAP.
My fish are sick. What should I do?
Contact your monitor or fish health professional. Disease treatments can sometimes be avoided by changing the water quality or reducing fish densities. If you need to conduct an INAD study, then reach out to an AADAP employee.
Why don’t I receive notification emails from the INAD database?
When changes are made to your account information or your study is advanced to the next stage, you should receive an email notification from the INAD database. It is likely that these notifications may end up in your junk folder or your company may identify them as potential spam. Please check your junk folder or contact your IT department to ensure this is not happening.
Who should I contact if I have questions about study stages?
All treatments conducted under an INAD are referred to as a study. There are seven stages of the study process as described below. If you have questions, please contact the appropriate individuals listed in the stages below.
- Stage 1: Before treatment can begin, an investigator must fill out and submit a Study Request to the monitor.
- Stage 2: The monitor will review and advance the Study Request to AADAP.
- Stage 3: AADAP will review the Study Request, assign a study number, and advance it to the next stage.
- Stage 4: Treatment can now begin. Once the treatment is completed and all data has been collected, the investigator then enters the data into the Results Report and submits it to the monitor.
- Stage 5: The monitor will review the Results Report and advance the study to AADAP.
- Stage 6: AADAP will review the study for the last time and determine if it can be approved.
- Stage 7: The study will be archived in the database and accessible to study participants.

If information is missing, the protocol is not followed, or forms are not correctly filled out, both the monitor and AADAP can send a study back to a previous stage.

INVESTIGATIONAL NEW ANIMAL DRUGS (INADs) UNIVERSITY - SOPHOMORE LEVEL

INVESTIGATIONAL NEW ANIMAL DRUGS (INADs) UNIVERSITY - JUNIOR LEVEL

INVESTIGATIONAL NEW ANIMAL DRUGS (INADs) UNIVERSITY - SENIOR LEVEL