Research Registration Instructions for Coordinators and Nurses

After your study participant has signed the IRB approved informed consent:

1. Complete and fax or email a copy of the Enrollment Form and Pre-Registration Form to the CTO. (This Enrollment form only needs to be filled out one time for each study participant.)
   
   
2. Any time your study participant is to be admitted as an inpatient and that inpatient visit involves charges that need to be billed to your grant, you need to complete a Research Reservation Request Form and fax or email the completed form to the CTO. A copy of the Enrollment Form must also be submitted with the Research Reservation Request Form if this has not already been completed for the study participant.
   
   
3. If any of the tests or services performed as part of the clinical trial are to be billed to your grant, your study participant will need a Clinical Trials ID Card. The CTO will database the enrollment form information and take care of pre-registration if needed. We will then create the Clinical Trials ID Card for your study participant. A hot pink card will be created for all study participants except those study participants who are enrolled in healthy volunteer studies. Healthy volunteer participants will receive a lime green card.
   
   
4. The coordinator or research nurse is responsible for issuing the card to the study participant and explaining its use. The study participant needs to be instructed to present the card at each study-related visit. A helpful reminder from the coordinator or research nurse upon scheduling the visit would be appropriate.
   
   
5. When your study participant visits the hospital for a trial related test or service, they must present the Clinical Trials ID card. Registration personnel have been instructed not to complete the patient registration if the participant does not have a Clinical Trials ID card, unless the CTO can be reached by phone in order to authorize the registration.
   
   
6. The above instructions will help ensure that hospital charges and bills are handled correctly. However, in order for any professional fees associated with your study participants visit to happen correctly, you will need to confirm that the fee slip or encounter form filled out for that service is done correctly.