Investigational New Animal Drugs (INADs) University - Sophomore Level

Sophomore Level: This material is intended for participants currently enrolled in the INAD Program who are looking for information on managing their online accounts or submitting Study Requests.

Subject 1: Database entry

• I forgot my login information. How do I access my account?
  If you forgot your login information, it can be accessed by clicking the “Forgot Username/Password” on the INAD database homepage. If you are a new investigator taking over the current account, contact AADAP to receive the login information.
   
• How do I make changes to account information?
  Updating your contact information, enrollment, and fish species treated can all be done from the investigator’s “Account Info” page. To access this page, login to the investigator’s account on the INAD database and click the “Account Info” tab on the top right of the page. Be sure to click the “Save Data” button at the bottom of the page to save the changes.
   
• How do I change the investigator or monitor on the account?
  Replacing either the investigator or monitor is easy. First, share the login information of the previous investigator/monitor with the new individual. Once they log in, select the “Account Info” tab on the upper-right of the page. They can then update the contact information to reflect their own, as well as change the username and password. Replacing the investigator/monitor is preferred, rather than creating a new account. This will enable the new individual to access previously conducted studies.
   
• How do I re-enroll in the program?
  You must enroll for each year that you wish to participate in the INAD Program. Enrollment takes place on the investigator’s “Account Info” page under the INAD Sign-up section. When enrollment is completed you will need to click on the “Save Data” button at the bottom of the page. You will be charged the INAD fee for each year that you enroll in the program.

Subject 2: Drug inventory

• How can I order the drug?
  First, you must submit a Study Request. Once AADAP assigns a study number (advances the study to Stage 4), we will notify the supplier that your facility has been approved to purchase the drug. You will then need to contact the supplier directly. Contact information for each supplier can be found on the INAD Fact Sheet page.
   
• How do I enter drug receipt information?
  Each time that you receive the drug it is important that you enter a new drug receipt. To enter the drug receipt info, select the “Manage/View Drug Inventory” from the investigator’s homepage. From the “Manage/View Drug Inventory” page, click the “Receipt of Drug” in the brown box on the upper left of the page. Enter all information and click “Add To Drug Inventory” to save. Remember, you will need to repeat this process each time you receive the drug from the supplier.
   
• Can I transfer an extra INAD drug to other facilities?
  Yes, extra INAD drug can be transferred to other facilities participating in the INAD Program. To transfer the drug, click “Manage/View Drug Inventory” from the investigator’s homepage; select the inventory to transfer; click the transfer button; fill out the information; and click save. The receiving facility will then need to enter the received drug into their inventory.
   
• How do I discard the drug?
  Please review the Safety Data Sheet (SDS) disposal section to determine how to best dispose of each INAD. You can find the SDS sheet on the INAD Fact Sheet page (Select the drug; click “Study Protocol” in blue text in the second paragraph; and in the table of contents you can click on the SDS section).
  
  You will need to edit the drug receipt information in your account to notify AADAP that the drug was discarded. To do this, click on the “Manage/View Inventory” page in the INAD database; click “Discard”; enter the date and amount to discard; then click “OK” to save the changes.

Subject 3: Study Request

• When can I start INAD treatments?
  Prior to beginning treatment, you and your monitor must first identify the specific needs of the fish and determine which INAD will be most appropriate for use. Then you will need to submit a Study Request in the INAD database. AADAP will assign a study number to your request at which point you can begin to initiate treatment.
   
• What is a study number?
  A study number is assigned by AADAP to each treatment (or study) conducted under an INAD. This allows us to track and reference each individual study while it is taking place and after it is completed. Only AADAP can edit the study number.
   
• Do I need a Veterinary Feed Directive (VFD) to order an INAD-medicated feed?
  A VFD is not needed when working with the INAD Program. For medicated feed INADs we ask that you provide the contact information for the feed mill you would like to work with in your Study Request form. AADAP is responsible for contacting feed mills and notifying them of your approved use of their product under the INAD.
   
• Can I use an INAD drug in an emergency when AADAP is not available (i.e., holiday)?
  The FDA allows for compassionate use if there is a disease outbreak which threatens the livelihood of your fish. If such event occurs, and you have not already submitted a Study Request, contact your monitor to work out a treatment plan which follows the required protocol. Begin treating your fish and submit a Study Request ASAP. Then notify AADAP of the circumstances.

Subject 4: Study-details

• When is a new study number needed?
  A new study number is needed (e.g., a new Study Request will need to be submitted) anytime a new therapeutic or sex reversal treatment is initiated. If the start date of treatments will be staggered over multiple days, then each treatment will need its own study number. For anesthetic, marking, or spawning INADs there are different guidelines. Generally, a new study number will be needed if there are more than 30 days between treatments, different doses will be used, or the treatment crosses into the new year by more than two weeks.
  
  AADAP will let you know if you need to break your studies into multiple study numbers after reviewing the Study Request. If treatments have already occurred there may be occasions where we request the study be broken into multiple study numbers so the data can be better evaluated. Please keep in mind that large or long studies may require multiple Study Request forms to be submitted.
   
• My species isn’t listed in the “Fish Species Treated” drop-down menu on the Study Request form, what should I do?
  If the species you plan to treat is not listed in the drop-down menu on the Study Request form, this means that you have not enrolled in the INAD to treat that species. You can add enrollment to treat the species on the investigator’s “Account Info” page. Scroll to the bottom of the form and add the species to the enrollment table. Once this is done, click on the Save Data button and the species will appear in the study request drop-down menu.
   
• Do I need controls in an INAD study?
  Controls, or non-treated control fish, are not required in INAD studies, as we understand that fish numbers are often limited. However, adding controls to INAD data provides strong support for whether the drug was effective. When possible, controls are encouraged.
   
• How do I determine the percent of fish saved on the Results Report?
  Since controls are not used in the majority of INAD studies, we cannot truly calculate the percentage of fish which were saved due to the INAD treatment. However, we do ask that investigators provide an estimate of the percentage of fish they believe were saved due to INAD use. This estimate can be based on past facility history or mortality rates prior to treatment.

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