当前位置:公众访问 >页面
简体中文 / English
1.Screening
1.2.Inclusion Criteria

Eligible participant has to fullfill all of the following items

1.3.Exclusion Criteria

Date

yyyy-mm-dd

2.Baseline

2.2.General information

Did you experienced any drug allergy?

Namy of the drug to be allergied

Date of drug allergy happened

yyyy-mm-dd/mm-dd

Current status

Date of birth:

yyyy-mm-dd

Gender

Nationality

Age

Years

Occupation

2.3.Physical examination

Systolic pressure (SP)

mmHg

Diastolic pressure

mmHg

Temperature

degree Celsius

Position of measurement

Pulse rate

次/分

Breath frequency

次/分

2.2.3.2.3.1、

2.4.Blood Routine Tests

Hb

g/L

RBC

X10^9/L

%

WBC

X10*3/L

PLT

X10*9/L

%

Erythrocyte sedimentation rate

mm/h

Date of test

2.5.Urine Routine Tests

pH

Clinical judgement

WBC

/μl

Clinical judgement

ERY

/μl

Clinical judgement

GLU

mmol/L

Clinical judgement

PRO

g/L

Clinical judgement

2.7.Coagulation Function Tests

Date of examination

yyyy-mm-dd

Prothrombin time

Clinical significant

Thrombin time (TT)

Clinical significant

Activated partial thromboplastin time (APTT)

Clinical significant

Fibrinogen (FIB)

g/L

Clinical significant

2.8.Serum Liver Function Tests

ALT

IU/L

AST

IU/L

AST/ALT

γ-Glutamyltransferase

IU/L

GGT

U/L

Serum bilirubin

μmol/L

Indirect bilirubin

umol/L

Direct bilirubin

umol/L

Serum albumin

g/L

Serum globulin

g/L

Serum total protein

g/L

A/G

Date of test

yyyy-mm-dd

2.9.

HbA1c

%

Blood glucose

mmol/L

Triglycerides

mmol/L

Total cholesterol

mmol/L

High density lipoprotein cholesterol

mmol/L

Low density lipoprotein cholesterol

mmol/L

NHDL

mmol/L

TCHO/HDL-C

%

Date of examination

yyyy-mm-dd

2.10.Renel Function Test

Date of examination

yyyy-mm-dd

Urea nitrogen

Clinical significant

Creatinine

umol/L

Clinical significant

Cystatin C

mg/L

Clinical significant

Uric acid

umol/L

Clinical significant

2.11.Heat Function Examination

AST

U

LDH

IU

Lactic dehydrogenase isoenzyme

α-HBDH

U/L

Creatine Kinase, CK

U/L

Creatine kinase isoenzyme, CKMB

U/L

Date of tests

yyyy-mm-dd

2.13.Image Examinations

3.In the process of the treatment
3.1.

Starting time

yyyy-mm-dd

3.2.

Name of the drug

ALT

IU/L

AST

IU/L

AST/ALT

γ-Glutamyltransferase

IU/L

Serum bilirubin

μmol/L

Indirect bilirubin

umol/L

Direct bilirubin

umol/L

Serum albumin

g/L

Serum globulin

g/L

Serum total protein

g/L

A/G

Date of test

yyyy-mm-dd

Urea nitrogen

Clinical significant

Creatinine

umol/L

Clinical significant

Cystatin C

mg/L

Clinical significant

Uric acid

umol/L

Clinical significant

Date of examination

yyyy-mm-dd

3.3.

3.4.

3.5.

3.6.

4.At the end of the treatment
4.1.

Name of the drug

Indication

The form of a drug

Single dose

Dose unite

The way of giving drug

Frequency of giving drug

Starting time

yyyy-mm-dd

Does it current continue?

Time of completed the treatment

yyyy-mm-dd

4.2.Physical examination

4.3.Blood Routine Tests

WBC

×109 /L

NEUT%

%

LY%

%

MONO%

RBC

×10^12 /L

HGB

g/L

PLT

×10^9 /L

Researcher signature

Date

yyyy-mm-dd

4.4.Urine and Stool Routine Tests

Acidity and allkalinity

pH value

Urine protein

Urine red cell

Urine WBC

Urine glucos

Urine Bilirubin

Urine HCG

KET

SG

UBG

NIT

Date of test

yyyy-mm-dd

4.6.Liver Function Tests

ALT

IU/L

AST

IU/L

AST/ALT

γ-Glutamyltransferase

IU/L

GGT

U/L

Serum bilirubin

μmol/L

Indirect bilirubin

umol/L

Direct bilirubin

umol/L

Serum albumin

g/L

Serum globulin

g/L

Serum total protein

g/L

A/G

Date of test

yyyy-mm-dd

4.8.Renel Function Test

Date of examination

yyyy-mm-dd

Urea nitrogen

Clinical significant

Creatinine

umol/L

Clinical significant

Cystatin C

mg/L

Clinical significant

Uric acid

umol/L

Clinical significant

4.9.Heat Function Examination

AST

U

LDH

IU

Lactic dehydrogenase isoenzyme

α-HBDH

U/L

Creatine Kinase, CK

U/L

Creatine kinase isoenzyme, CKMB

U/L

Date of tests

yyyy-mm-dd

4.10.Image Examinations

5.

6.

7.

The date of the last site visiting

年月日(yyyy-mm-dd)

8.Management system of participants
9.Speciman management system
10.Data management system
11.ADR/ADE management system
12.Madicine management system
13.Instruments management system
14.SOPs
14.1.Treatment SOP
14.2.Nursing SOP
14.3.Specimen collection SOP
15.Research team
15.1.Institutions

15.2.Researchers

16.Design, Methods
16.1.Calculation of sample size