What to Expect When You Participate
Introduction of the Study – The first you may hear about a study is when your physician or nurse informs you about the study as a possible course of treatment. Then, you may also receive a call from an ECR study coordinator and receive a copy of the study information in the mail. This is a good time to read all the information and call back with any questions so you can make an informed decision.
First Appointment – All studies are different so you need to read the information provided to you to learn about the exact procedures done at this visit. No matter what, the visit will begin with the informed consent process. Your physician and the coordinator will go over this document with you, answer all your questions, and make sure you understand the study before you sign up for participation. Once you have signed informed consent and agreed to participate in the study, the physician will examine you and the study coordinator will complete screening procedures such as obtaining blood and urine samples and taking your vital signs. This visit can last from 60 to 90 minutes.
Results Phone Call – The coordinator assigned to your study will call you once all of the results from your first visit tests are in and have been reviewed by the physician. The coordinator will let you know if you qualify for study participation based on the opinion of the physician. If you qualify and are still interested in participating, the coordinator will schedule your next visit with you.
Second Visit – This visit marks day 1 of your study participation. It is at this visit that you are given your first dosage of study medication. The coordinator will also review the dosing instructions, possible side effects, and other important information with you. You may also have labs drawn or other procedures done. This visit can last from 60 to 90 minutes.
Study Visits – Depending on the study length, required procedures, and dosing schedule you may have a few or multiple study visits throughout the trial. The coordinator will schedule all of these visits with you and call you to remind you of upcoming visits. Usually at these visits you will have labs drawn and your vitals taken, and maybe a physical exam or other procedures. At these visits you will also bring in your used study medication and be given a new supply. You may also have to bring in a study diary if the protocol requires it. These visits can last from 30 to 60 minutes.
Between Visits – Just because you do not have a clinic visit scheduled does not mean you are on your own. Your coordinator and physician are always available to take your calls or see you between study visits. If you have questions or are experiencing side effects, you can be seen in the office usually within one business day.
End of Study – The end of study visit is the final time you will see your coordinator for the study. All study medication is collected, many procedures are done, and instructions are given to you on how to follow-up with the physician on your continuing treatment. If a physical exam is not required for this visit, the study coordinator schedules a regular office visit with your physician for you in the next few months according to your usual treatment schedule. This visit can last from 60 to 90 minutes.