Must make our own Phase 2 study; 8 pages and come up with a introduction, selection and withdrawal of subjects, assessment of safety and analysis

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Informed-Consentpart.doc

South College Consent to Participate in Research

Study Title: Development FK67T

Researcher: ADD PRINCIPAL INVESTIGATOR’S NAME AND CONTACT INFORMATION HERE.

· You are being asked to participate in a research study. This consent form contains important information about this study and what to expect if you decide to participate. Please consider the information carefully. Feel free to ask questions before making your decision whether or not to participate.

· Your participation is voluntary. Your participation in this research is voluntary. You may refuse to participate in this study. If you decide to take part in the study, you may leave the study at any time. No matter what decision you make, there will be no penalty to you or loss of benefits to which you are otherwise entitled. Your decision will not affect your future relationship with South College. If you are a student or employee at South College, your decision will not affect your grades or employment status.

· Purpose of the research. Our research purpose focuses on the development (FK67T) that will help to reduce the incidence of severe chest pain, tachycardia and lower blood pressure without severe fatigue and dizziness and depression associated with high-dose metoprolol.

· Number of people being asked to participate in the research. There will 50 patient who will participate in this study helps to evaluate the safety and efficacy this drug

· Duration of your participation. Max 5-6ADD TEXT HERE ON THE AMOUNT OF TIME, NUMBER OF ENCOUNTERS, ETC., IT WILL TAKE FOR THE SUBJECT TO PARTICIPATE IN THE RESEARCH.

· Description of procedures to be followed in the research. This research involves a blood sample to see the safety and efficacy of new compound. However, blood sample is painless

· Reasonably foreseeable risks or discomforts. Any risk can appear during the process. The health care worker will be looking after you.

· Benefits to you or others that may reasonably be expected from the research. If you participate in this research, you will have the following benefit for you: any interim illnesses will be treated at no charge to you. There may not be any benefit for you, but your participation is likely to help us evaluate the safety and efficacy of this compound.

· Alternative procedures. If Patient does not want to participate in clinical trial, they can have alternative treatment.

· Confidentiality of records identifying you. The information and data we will collect from this trial will kept confidential and it will be safe in computer. Computer will have password, and no one will be able to get into it except professionals. Any information about you will have number on it instead of your name only researcher will know what your number. As we already mention that all the information will be in computer and no one will be able to access the information except company and sponsors.

· Answers to your questions. For questions, concerns, or complaints about the study you may contact the researcher. His/her name and contact information are listed at the top of this consent form.

Signing the consent form

I have read (or someone has read to me) this form, and I am aware that I am being asked to participate in a research study. I have had the opportunity to ask questions and have had them answered to my satisfaction. I voluntarily agree to participate in this study.

I am not giving up any legal rights by signing this form. I will be given a copy of this form.

Printed name of subject

Signature of subject

Date

Printed name of person authorized to consent for subject (when applicable)

Signature of person authorized to consent for subject

(when applicable)

Relationship to the subject

Date

Investigator

I have explained the research to the participant or his/her representative before requesting the signature(s) above. A copy of this form has been given to the participant or his/her representative.

Printed name of person obtaining consent

Signature of person obtaining consent

AM/PM

Date and time

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