How to Enroll in the Investigational New Animal Drug (INAD) Program

Welcome to the Investigational New Animal Drug or INAD enrollment tutorial. You will be taken through the enrollment process step by step.  Also, all data entry is done electronically in the INAD database, and the paper forms within the protocol are only meant to guide investigators in the collections of data.

Study Monitor vs. Study Investigator

Prior to participating in the INAD program, its important to decide which staff members will serves as "study monitors" and which will serve as "study investigators. The study monitor cannot be the same person as the study investigator. I will discuss each of these roles shortly.

Study Monitor Duties

The monitor's duties include supervising the study, ensuring data is submitted on time, and reviewing their studies in the database. This role is often filled by the fish health professional or a veterinarian.

Study Investigator Duties

The investigator is responsible for conducting the studies and entering all data into the database.

When assigning study roles

The monitor and investigator cannot be the same person due to the level of oversight required for INAD studies. It's important to note that there may be multiple investigators will share one account in the online database. The exception to this is if there are multiple facilities in the same organization. In that case, each facility needs its own investigator account, and data is to be reported separately for each facility. When enrolling, the study monitor must create their account first, followed by the investigators.

Steps to Enroll in an INAD

Enrollment allows us to see which INADs participating facilities are using and the species they plan to treat. Below are the instructions for how to enroll.  

1. First, go to the Services link on the top navigation of the https://www.fws.gov/ webpage. 
2. Scroll down to Investigational New Animal Drugs. You will see a list of INADS.
3. Click on the one that you are interested in, and visit the data collection site.
4. Once you are on the data collection site, scroll to the bottom and select the correct User Role. In this case, its the Study Monitor. Then click Create Account.
5. Next, create a User Name and then a Password, according to the password requirements. 
6. Enter your name and email address, and then fill in the rest of the General Study Monitor information.
7. When finished, click Submit for Approval
8. Now go back to the data collection site, which is found on the INAD information pages.
9. Scroll to the bottom and select the correct User Role which is in this case is the Facility Investigator. Then click Create Account.
10. Next, create a User Name and then a Password, according to the password requirements. 
11. Enter your name and email address, and then fill in the rest of the General Facility information.
12. When you get to the study monitor section, select the Study Monitor for this facility from the dropdown list. This is why the study monitor must create their account first, otherwise they won't be listed as a choice in the dropdown menu.
13. When you get to the Number of Fish to be Treated section, please note that this is a numbers only field. Do not enter text or a range of numbers into this field.
14. Click Add Drug/INAD to add any additional INAD use to your account. 
15. When you have filled in all the required information, click Submit for Approval.
16. Once you have submitted your account for approval, you will receive an email when it is active and our administrator will send you any pertinent information that you are enrolled under at the time.