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Date of Assessment: __ __ / __ __ __ / __ __ __ __

(DD / MMM / YYYY)

Was Physical Examination performed? No Yes, Complete below
System *Abnormal Normal Not done *If noted ABNORMAL, please provide brief description and comment if clinically significant or not (CS/NCS)
General Appearance        
Skin        
Eyes, Ears, Nose & Throat        
Head, Neck & Thyroid        
Cardiovascular        
Respiratory        
Abdomen        
Extremities        
Genitalia        
Anorectal        
Lymph Nodes        
Muscular-Skeletal        
Neurological        
Others (please specify)        
           

 

 

VISIT 1 (SCREENING)vital signs & ECG

 

Were Vital Signs performed?     No (comment below) Yes,Complete below   Comment*: __________________
Date of Vital Signs: __ __ / __ __ __ / __ __ __ __ (DD / MMM / YYYY)
Time of Vital Signs: ________:_______ HH:MM
Blood Pressure supine/standing/seating :___ ___ ___ / ___ ___ ___ mmHg
Pulse:____ ___ ___ beats/min
Weight:___ ___ ___ . ___ kg Height:___ . ___ ___ m
Oral/ Tympanic Temperature: ___ ___ . ___ °C

 

Was an ECG performed?   No (comment below) Yes,Complete below   Comment*: __________________
Date & Time of ECG: __ __ / __ __ __ / __ __ __ __ ________:_______   (DD / MMM / YYYY) HH:MM
The ECG is: Within normal limits Abnormal, NOT clinically significant Abnormal, clinically significant, please specify: _____________________________________________________________
     

 

 

VISIT 1 (SCREENING)HAEMATOLOGY

 

Clinical Haematology Laboratory tests performed?   No (comment below) Yes,Complete below   Comment: __________________
Date of Sample: __ __ / __ __ __ / __ __ __ __ (DD / MMM / YYYY)
Time of Sample ________:_______ HH:MM
Was laboratory sample taken at different hospital to <insert investigator’s site lab name>? No Yes, Complete below Laboratory name / Location: __________________________________________

 

HAEMATOLOGY Laboratory Parameter Value Unit (site to pre-complete prior to the finalization of the template) If parameter indicated as out of normal range on report, please check if clinically significant:
WBC     No Yes
RBC     No Yes
Hb     No Yes
HCT     No Yes
MCV     No Yes
MCH     No Yes
PLT     No Yes
NEUTROPHILS     No Yes
LYMPHOCYTES     No Yes

 
MONOCYTES     No Yes
EOSINOPHILS     No Yes
BASOPHILS     No Yes
RETICULOCYTES     No Yes

 

 

VISIT 1 (SCREENING)BIOCHEMISTRY

 

Clinical Biochemistry Laboratory tests performed?   No (comment below) Yes,Complete below   Comment: __________________
Date of Sample: __ __ / __ __ __ / __ __ __ __ (DD / MMM / YYYY)
Time of Sample ________:_______ HH:MM
Were laboratory samples taken at different hospital other than <insert investigator’s site lab name>? No Yes, Complete below Laboratory name / Location: __________________________________________

 

BIOCHEMISTRY Laboratory Parameter Value Unit (site to pre-complete prior to the finalization of the template) If parameter indicated as out of normal range on report, please check if clinically significant:
SODIUM     No Yes
POTASSIUM     No Yes
CHLORIDE     No Yes
BICARBONATE     No Yes

 

UREA     No Yes
CREATININE     No Yes
TOTAL PROTEIN     No Yes
TOTAL BILIRUBIN     No Yes
ALBUMIN     No Yes
ALK PHOS     No Yes
ALT     No Yes
AST     No Yes
CALCIUM     No Yes

 

 

VISIT 1 (SCREENING)< iNSERT ASSESSMENT>

 

Clinical <insert assessment> Laboratory tests performed?   No (comment below) Yes,Complete below   Comment *: __________________
Date of Sample: __ __ / __ __ __ / __ __ __ __ (DD / MMM / YYYY)
Time of Sample ________:_______ HH:MM
Was laboratory sample taken at different hospital to <insert investigator’s site lab name>? No Yes, Complete below Laboratory name / Location: __________________________________________

 

<INSERT ASSESSMENT> Laboratory Parameter Value Unit (site to pre-complete prior to the finalization of the template) If parameter indicated as out of normal range on report, please check if clinically significant:
      No Yes
      No Yes
      No Yes
      No Yes
      No Yes
      No Yes
      No Yes
      No Yes
      No Yes
      No Yes
      No Yes
      No Yes
      No Yes

 

VISIT 1 (SCREENING)Screening Concomitant Medications

Date: 2016-03-03; view: 1047

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