Fish and Aquatic Conservation

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

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

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

We hope this tutorial provided the guidance needed for INAD enrollment. If you need further assistance please contact the INAD program.