Real Time Immunization Monitoring System (RTIMS)

Information for
Influenza Vaccine Providers

Thank you for your interest in collaborating with us to
monitor influenza vaccine safety across the United States. 
With support from the CDC, we have created an automated internet-based system that will follow-up
on any self-reported adverse symptoms to influenza vaccine after vaccination.

What is this study about?

The Real Time Immunization Monitoring System (RTIMS) study is a nationwide CDC-sponsored study to monitor the safety of both the seasonal and H1N1 influenza vaccines in real time. This study will use an automated web-based system developed at the Johns Hopkins School of Public Health to follow up on vaccine recipients up to 6 weeks post-vaccination.

We do not expect many serious adverse events to the vaccine; however, we would like to detect any unanticipated problems as quickly as possible.  Your participation will be an important contribution to public health surveillance efforts in your state and across the country.

This letter of support from the CDC provides a good summary of the project.  

What is being asked of vaccine providers?

While we understand the substantial coordination efforts involved in conducting your vaccination program, we are seeking your assistance to help us identify persons willing to be contacted after influenza vaccination.  

We are asking that you kindly help us collect the full name and email address of participants at the time of vaccination.  This contact information will be forwarded to study investigators at Johns Hopkins (more details below).  When we receive the contact information, an email will be sent to each vaccine recipient informing them about the study asking for their consent to participate.

We appreciate the time and planning constraints you are dealing with at this time of the year.  We will minimize any additional burden upon your team by providing simple, step-by-step instructions on how to send us this contact information.  We will pay for all materials and logistics.

What exactly will I have to do?

1. We will send you study information cards, posters, and FedEx® shipping boxes with pre-paid, pre-addressed shipping labels. The study information cards provide information about our study and has fields for vaccine recipients to fill in their contact information.

2. We would like you to give out these cards to vaccine recipients on the day of vaccination together with your influenza vaccine consent form.

3. Vaccine recipients interested in being contacted about this study will fill out the card and place them in a box.  

4. At the end of each week or every other day, clinic personnel will simply place the cards in the provided FedEx box and mail it to us. We can arrange for FedEx® pick-up from individual sites.

Click here to download a pdf of these instructions.

Does gathering contact information require IRB approval?

As a vaccine provider, forwarding the contact information of persons who have agreed to be contacted does not constitute active research.  Therefore participating sites do not need to apply for IRB approval and are exempt from HIPAA Privacy Rules as per the guidelines from the Office for Human Research Protections (OHRP).  Please refer to this letter from the OHRP.

Materials that may be of interest:

CDC Letter of Endorsement  

Summary of the RTIMS project protocol  

DHHS Letter re: IRB approval 

Instructions for Providers  

This page was last updated on October 15, 2009

© 2009 Institute for Vaccine Safety