Participant Information Notice
&
Informed Consent
Participant Information Notice
&
Informed Consent
Contents
1. Participant Information Notice
2. Informed Consent
Informed Consent Form No: PG_EPO_Ph3_ICF_Site Name_v2.3
Date: 2013.07.23
Research Centre : Zaki Morad Nephrology Services Sdn Bhd
Researcher : Dr. Zaki Morad Mohd Zaher
Sponsors : Main Sponsor- CCM Duopharma Biotech Bhd. and
PanGen Biotech Inc..
Confidential
Notification of participants and informed consent contains all the information is confidential.
Notification of participants and informed consent contains all the information is confidential.
Participant Information Notice
Participant Information Notice
Research Question: a multi-center, multinational, randomized, active-controlled, parallel-group clinical study to evaluate PDA10 (erythropoietin-α) compared to Eprex ® for chronic renal failure anemia patient safety and effectiveness.
You are invited to participate in this study by leading doctor, Dato 'Dr Zaki Morad Mohd Zaher performed by CCM Duopharma Biotech Bhd., And PanGen Biotech Inc. Partly funded sponsored clinical study. This Participant Information Notice will provide you with information about this study, including its purpose, procedures, benefits, risks and research-related symptoms. If you have any questions or quieries, please contact the attending doctor or nurse. Before signing this consent form, you must read and understand the information inside, your doctor will study detailed answer all of your questions. If your question has not been fully answered, you can choose not to sign an informed consent form.
In deciding whether to consent or participate in this clinical trial, you can communicate with your family or friends to discuss. Participation in this study is voluntary. Even if you have fully understood this clinical study, you can decide not to participate. If you