Page:PARAMOUNT Eli Lilly Informed Consent Document.djvu/8

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Do I Have To Take Part In This Study?
Your taking part in this study is entirely voluntary. Whether or not you take part is completely up to you to decide. You will continue to receive the best possible care no matter what you decide.


If you choose to take part and later change your mind, you can stop participating at any time. A decision to stop being in the study will not affect how your health care is provided to you. If you decide to stop the treatment, please talk to the study doctor or one of the staff members. They can tell you about any other treatments, and arrange to continue your usual care.


Your study doctor or the sponsor might decide, at any time and for any reason, to stop your taking part in the study, even though you might want to continue. This might happen if you have a bad reaction to pemetrexed or if there is new information about the safety or effectiveness of pemetrexed. The study doctor or one of the staff members will explain the reasons why you must stop and arrange for your health care to continue.


Treatment and Compensation for Injury
In Canada, health care is provided through a system of provincial insurance. This insurance may or may not provide coverage for certain types of injuries that might result from your taking part in this study. To the extent that provincial insurance does not cover physical injury caused by any substance or procedure properly given under the plan for this study, Eli Lilly and Company will pay the medical expenses for the treatment of that injury so long as you have followed the direction of the doctors in charge of the study. Signing this form does not mean you give up any of your legal rights. The study doctor, sponsor or hospital would still have legal and professional responsibilities to you.


What Will The Study Cost Me?
Study drug and study procedures will be provided at no cost to you. However, you might have to pay for some expenses related to your taking part in this study, such as [transportation, parking, meals or others].

You will be paid [insert amount per study visit] to reimburse you for [transportation, parking, meals or other] expenses related to your taking part in this study. If you withdraw from the study early you will be paid for these expenses for the portion of the study that you completed.


Who Is Paying For The Research Study?
The sponsor is paying the study doctor and/or [name of Institution or site] for their work in this study.


Who Do I Contact If I Want To Report Health Problems Or Have Questions?

If you have any injury, bad effect, or any other unusual health experience during this study, make sure that you immediately tell the study doctor or other study staff. You can call at any time, day or night, to report such health experiences, [insert contact details]

H3W-EW-S124 (b)
Version: 26-October-2009
Page 8 of 14
Confidential