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

 

(DD / MMM / YYYY)

 

Is the participant taken any concomitant medications at screening or <insert time frame as specified in protocol> No Yes,Complete below
Medication (Record Generic or trade name) Reason for use(Medical History diagnosis or other reason, e.g. Prophylaxis) Dose and units Freque-ncy Route Start Date (DD/MMM/YYYY) Stop Date(DD//MMM/YYY) Or tick if ongoing at Screening Visit
1.         ____/_____/_____ ____/_____/_____  
2.         ____/_____/_____ ____/_____/_____  
3.         ____/_____/_____ ____/_____/_____  
4.           ____/_____/_____ ____/_____/_____  
5.         ____/_____/_____ ____/_____/_____  
6.         ____/_____/_____ ____/_____/_____  
7.         ____/_____/_____ ____/_____/_____  
8.         ____/_____/_____ ____/_____/_____  
9.         ____/_____/_____ ____/_____/_____  
10.         ____/_____/_____ ____/_____/_____  

 

VISIT 1 (SCREENING)Smoking / Alcohol Status

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

(DD / MMM / YYYY)

 

Has the participant ever smoked? No Yes,Complete below
Current Smoker Participant’s average daily use: - Number of cigarettes : ___ ___ - Number of cigars : ____ ___ - Number of pipes : ___ ___   Smoked for ___ ___ months/years
Former smoker Smoked for ___ ___ months/years Date when smoking ceased: __ __ / __ __ __ / __ __ __ __ (DD / MMM / YYYY) When smoking, participant’s average daily use: - Number of cigarettes : ___ ___ - Number of cigars : ____ ___ - Number of pipes : ___ ___    

 

 

Participant’s alcohol consumption
Participant’s average consumption per <insert time frame stated in protocol>: - Number of units of wine : ___ ___ - Number of units of beer : ____ ___ - Number of units of spirits : ___ ___ (see protocol for definition of units)  

 

 


 

 

VISIT 1 (SCREENING)Inclusion Criteria

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

(DD / MMM / YYYY)

 

The following criteria MUST be answered YES for participant to be included in the trial (except where NA is appropriate): Yes No N/A
1.        
2.        
3.        
4.        
5.        
6.        
7.        
8.        
9.        
10.        
If any of the above criteria is answered NO, the participant is NOT eligible for the trial and must not be included in the study. Please list reason(s) for ineligibility for screen failure on Participant Eligibility Review page.

 




 

 

VISIT 1 (SCREENING)exclusion Criteria

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

(DD / MMM / YYYY)

 

The following criteria MUST be answered NO for the participant to be included in the trial: Yes No
1.        
2.      
3.      
4.      
5.      
6.      
7.      
8.      
9.      
10.      
If any of the above criteria is answered YES, the participant is NOT eligible for the trial and must not be included in the study. Please list reason(s) for ineligibility for screen failure on Participant Eligibility Review page.

 


 

VISIT 1 (SCREENING)participant eligibility review

 

End of Screening Visit Checklist:
  Yes No
1. Does the participant satisfy the inclusion and exclusion criteria to date?    
2. Have all Screening Visit procedures been completed?    
3. Have the Medical History and Concomitant Medication pages been completed?    
4. Is the participant still willing to proceed in the trial?    

 

 

Participant’s eligibility Investigator Sign-Off:  
Is the participant eligible to take part in the Clinical Trial?   Investigator’s Signature: __________________ Date :__ __ / __ __ __ / __ __ __ __ (DD / MMM / YYYY)   Investigator’s Name: __________________ Yes   No, Please give reason for screen failure below
Reason(s) for screen failure:
1.
2.
3.

 


 


Date: 2016-03-03; view: 763


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