• Clinical Trial Informed Consent Form

    Clinical Trial Informed Consent Form

  • Dear participant:

    As we have reached a new breakthrough in medical technology, it is with honor that we invite you to clinical trials. Your involvement will not help address your condition but also help in the success of addressing similar conditions of others globally.

    Your participation in this clinical trial is voluntary. You can freely ask your research doctor if you have any, any of our research doctors, your physician, family, and friends before you can make your final decision in participating in this clinical trial. 

    Please read carefully this informed consent form, and then decide whether you wish to participate in this clinical trial.

  • Purpose of Clinical Trial

  • In the recent event of the growing population of people infected by the disease, our research team has developed a drug that is intended to destroy the virus causing the said disease. Initial tests conclude a 99% success rate for such drugs to be a cure and that is ready for production; however, we need to finalize that this new drug shall indeed be the cure to address this disease. 

  • Selection and Conducting of Clinical Trial

  • We have invited a total of 139 people who based on the medical assessment has contracted the disease for this clinical trial. The drug shall be orally taken.

    During the Clinical Trial, some participants may be using a placebo or an inactive medicine. Such medicine has no effect because this is not real medicine. In some cases, we would want to know whether the medicine is good. We will not inform who gets a placebo and who gets the real medicine in order to know if the recovery was really effective due to the medicine or not at all.

    In case the medicine does not yield the desired effect, we will provide a rescue medicine.

  • Information about the Trial Medicine

  • We are testing an anti-flu drug and is on its final stage of testing.  Initial tests concluded an 85% success rate of recovery. The test to be conducted for this term is for validation purposes and if ever, to validate the cause of unsuccessful recovery was not due to the drug but due to other unrelated matters.

    Some may feel nauseated after taking the drug while others would feel a bit tired. This is a side effect of taking the drug. This should be fine and bed rest will suffice for the patient. No additional measures shall be needed to be taken.

  • Advantages and Disadvantages

  • The results from the clinical trial shall be our source to evaluate the progress of the medicine. This shall bear no additional cost from the participant and if successful, the ailment is considered treated without cost. However, we have no absolute prognosis given that the medicine is in its trial state.

  • Confidentiality

  • We believe in the right to privacy of any individual including yours. We will not, in all means, disclose your personal information to anyone including when conducting a study about your progress. Any information used shall be relevant and for the purpose of usage for the clinical trial conducted. Names shall not be disclosed to anyone even in abstracts or journals.

  • Who to Contact for Questions

  • If you have questions or concerns with regarding this clinical trial, you can contact:

    Name: Dr. Mary Gail Anderson
    Telephone number: 1-244-2040044
    E-mail: Maryanderson@researchtest.com

  • Consent

  • I have read the information above or it has been read to me and understand the purpose and of this clinical trial. I have had the opportunity to ask questions and by which all have been answered to my satisfaction. I give my consent to this clinical research and I voluntarily sign this informed consent to participate in this clinical trial.

     

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  • On behalf of the Participant, I have witnessed the accurate reading of the informed consent form for a clinical trial to the Participant, and have witnessed likewise that the Participant was given the opportunity to ask questions. I confirm that said participant has given his/her consent to participate in the clinical trial and I sign this clinical trial consent for the benefit of Participant as an act on behalf of and with the consent of the Participant.

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  • I have witnessed the accurate reading of the informed consent form for a clinical trial to the Participant, and have witnessed likewise that the Participant was given the opportunity to ask questions. I confirm that said participant has given his/her consent to participate in the clinical trial and I sign this clinical trial consent as a witness to this event and before the Participant.

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  • Researcher Statement

  • I have read out to the participant accurately, the information sheet, and have explained to him/her to the best of my ability any concerns and benefits pertaining to this clinical trial. 

    I confirm that the participant was given the opportunity to inquire about the clinical trial and that all questions were answered correctly and to the satisfaction of said participant. The participant was not in any way coerced, compelled, deceived into signing this consent, and that such consent was freely given by him/her voluntarily and freely.  

    A copy of this Consent has been provided to the participant. 

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