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
