एक फेज़ II डायबिटीज़ ड्रग ट्रायल के लिए सहमति
अनुसंधान टीमें और क्लीनिक IRB-शैली, सरल-भाषा वाले सहमति ड्राफ्ट बनाते हैं जिन्हें प्रतिभागी सच में समझ सकते हैं।
इनपुट और आउटपुट का पूर्वावलोकन देखें
इनपुट
- Procedure Info
- Phase II randomized controlled trial of a new oral diabetes medication (Drug X 500mg) vs. placebo over 12 weeks, including blood draws every 2 weeks and one MRI scan. Participants are adults with Type 2 diabetes. Compensation provided for travel.
- Procedure Type
- clinical-trial
- Risk Level
- moderate
- Audience
- research-participant
- Language Level
- plain-language
आउटपुट (अंश)
Consent to Take Part in a Research Study What is this study? We are testing a new diabetes pill (Drug X) to see how well it lowers blood sugar. You will be randomly placed in either the Drug X group or a placebo (no medicine) group. Neither you nor the doctor chooses which. What will happen? Over 12 weeks you will have blood drawn every 2 weeks and one MRI scan. Possible risks: Low blood sugar, mild bruising from blood draws. Your participation is voluntary and you may stop at any time.