- Screening
- Baseline
- In the process of the treatment
- At the end of the treatment
- Follow-up 1
- Follow-up 2
- Follow-up 3
- Management system of participants
- Speciman management system
- Data management system
- ADR/ADE management system
- Madicine management system
- Instruments management system
- SOPs
- Research team
- Design, Methods
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Eligible participant has to fullfill all of the following items |
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Date | yyyy-mm-dd |
- General information
- Physical examination
- Blood Routine Tests
- Urine and Stool Routine Tests
- Glucose test
- Serum Liver Function Tests
- Renel Function Test
- Heat Function Examination
- Image Examinations
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Gender | |
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Your age | 岁(years) |
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Date of birth: | yyyy-mm-dd |
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Nationality | |
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Marriage history | |
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Pulse rate | 次/分 |
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Breath frequency | 次/分 |
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Systolic pressure (SP) | mmHg |
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Diastolic pressure | mmHg |
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Did you experienced any drug allergy? | |
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Namy of the drug to be allergied |
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Date of drug allergy happened | yyyy-mm-dd/mm-dd |
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Doctor signature |
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Date | yyyy-mm-dd |
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Wagner grade | |
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Signature of the doctor |
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Date of examination | yyyy-mm-dd |
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WBC | ×109 /L |
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NEUT% | % |
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LY% | % |
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MONO％ | ％ |
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RBC | ×10^12 /L |
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HGB | g/L |
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PLT | ×10^9 /L |
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Date | yyyy-mm-dd |
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Acidity and allkalinity | |
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pH value |
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Urine protein | |
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Urine red cell | |
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Urine WBC | |
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Urine glucos | |
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Urine Bilirubin | |
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Urine HCG | |
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KET | |
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SG |
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UBG | |
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NIT | |
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Date of test | yyyy-mm-dd |
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Fasting blood glucos concentration | mmol/L |
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Two hours after breakfast | mmol/L |
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Two hours after lunch | mmol/L |
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Two hours after dinner | mmol/L |
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Date of test | yyyy-mm-dd |
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CRP | mg/L |
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Date of test | yyyy-mm-dd |
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Fib | g/L |
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t-PA | ug/L |
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PAI-1 | ug/L |
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Date of test |
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HbA1c | % |
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Date of test | yyyy-mm-dd |
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ALT | IU/L |
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AST | IU/L |
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γ-Glutamyltransferase | IU/L |
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Serum bilirubin | μmol/L |
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Indirect bilirubin | umol/L |
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Direct bilirubin | umol/L |
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Serum albumin | g/L |
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Serum total protein | g/L |
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Date of test | yyyy-mm-dd |
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Blood uric acid | μmol/L |
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SCr | μmol/L |
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Blood urea | mmol/L |
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Date of test | yyyy-mm-dd |
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Ultrasonic echocardiography, UCG | |
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Description in detail for abnormal |
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Date of examination | yyyy-mm-dd |
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AST | U |
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LDH | IU |
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Lactic dehydrogenase isoenzyme | |
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α-HBDH | U/L |
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Creatine Kinase, CK | U/L |
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Creatine kinase isoenzyme, CKMB | U/L |
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Date of tests | yyyy-mm-dd |
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Signature of the doctor |
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yyyy-mm-dd |
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ALT | IU/L |
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AST | IU/L |
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AST/ALT |
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γ-Glutamyltransferase | IU/L |
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GGT | U/L |
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Serum bilirubin | μmol/L |
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Indirect bilirubin | umol/L |
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Direct bilirubin | umol/L |
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Serum albumin | g/L |
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Serum globulin | g/L |
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Serum total protein | g/L |
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A/G |
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Date of test | yyyy-mm-dd |
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BUN | 8mmol/L |
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SCr | μmol/L |
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Blood urea | mmol/L |
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Blood uric acid | μmol/L |
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Cr |
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Blood endogenous creatinine clearance | ml·s-1/m*2 |
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BUN/Cr |
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Date of test | yyyy-mm-dd |
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ALT | IU/L |
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AST | IU/L |
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AST/ALT |
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γ-Glutamyltransferase | IU/L |
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Serum bilirubin | μmol/L |
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Indirect bilirubin | umol/L |
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Direct bilirubin | umol/L |
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Serum albumin | g/L |
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Serum globulin | g/L |
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Serum total protein | g/L |
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A/G |
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Date of test | yyyy-mm-dd |
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BUN | 8mmol/L |
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SCr | μmol/L |
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Blood urea | mmol/L |
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Blood uric acid | μmol/L |
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Cr |
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Date of test | yyyy-mm-dd |
- Management for Progress
- Blood Routine Tests
- Glucose test
- Liver Function Tests
- Renel Function Test
- Heat Function Examination
- Image Examinations
- Health Relative Quality of Life
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Is there any additional combination drug? | |
次 |
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WBC | ×109 /L |
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NEUT% | % |
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LY% | % |
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MONO％ | ％ |
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RBC | ×10^12 /L |
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HGB | g/L |
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PLT | ×10^9 /L |
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Researcher signature |
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Date | yyyy-mm-dd |
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HbA1c | % |
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Date of test | yyyy-mm-dd |
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Blood glucose | mmol/L |
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LAGE |
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MAGE |
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SDBG |
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MODD |
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LBGI |
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Date of test | yyyy-mm-dd |
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Daily usage of insulin | IU |
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Date of detection | yyyy-mm-dd |
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ALT | IU/L |
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AST | IU/L |
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AST/ALT |
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γ-Glutamyltransferase | IU/L |
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Serum bilirubin | μmol/L |
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Indirect bilirubin | umol/L |
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Direct bilirubin | umol/L |
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Serum albumin | g/L |
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Serum globulin | g/L |
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Serum total protein | g/L |
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A/G |
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Date of test | yyyy-mm-dd |
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BUN | 8mmol/L |
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SCr | μmol/L |
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Blood urea | mmol/L |
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Blood uric acid | μmol/L |
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Cr |
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Date of test | yyyy-mm-dd |
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Ultrasonic echocardiography, UCG | |
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Description in detail for abnormal |
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Date of examination | yyyy-mm-dd |
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AST | U |
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LDH | IU |
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Lactic dehydrogenase isoenzyme | |
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α-HBDH | U/L |
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Creatine Kinase, CK | U/L |
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Creatine kinase isoenzyme, CKMB | U/L |
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Date of tests | yyyy-mm-dd |
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Before primary wounding | 分 |
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Now (Current at moment) | 分 |
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Signature of the doctor |
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Date of examination | yyyy-mm-dd |
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Whether got the informed consent? | |
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Date of sign the informed consent | xx年xx月xx日 |
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Adverse events | |
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Name of the adverse event |
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Date of starting | yyyy-mm-dd |
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Ending time | yyyy-mm-dd |
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Does it continues to now | |
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Severity | |
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Corelation with the study drug | |
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The method of treating the drug | |
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The outcome | |
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Is it sevious adverse event? | |
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Did it resulted in stoped the study? | |
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Possible reason of causing the adverse event | |
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Person who report the adverse event |
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Time of the reporting | yyyy-mm-dd-hh-min. |