Attachment 1
MSD Phone Screening Procedures
OMB Control Number: 0925-XXXX Expiration Date: XX/XX/XXXX
Public reporting burden for this collection of information is estimated to average 10 minutes per response,
including the time for reviewing instructions, searching existing data sources, gathering and maintaining
the data needed, and completing and reviewing the collection of information. An agency may not conduct
or sponsor, and a person is not required to respond to, a collection of information unless it displays a
currently valid OMB control number. Send comments regarding this burden estimate or any other aspect
of this collection of information, including suggestions for reducing this burden, to: NIH, Project Clearance
Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-XXXX). Do
not return the completed form to this address.
MSD Phone Screening Procedures
Overview:
The purpose of this research study is to characterize the effects of <insert drug name> on driving performance.
Study Information, Time Commitment and Compensation:
Participating in this study
involves 3 visits. One of which is a 45 minute screening visit and
two 5-6 hour dosing visits.
Screening Visit:
For this visit you will be required to come to the University Research Park located on Oakdale Blvd in Coralville to participate. At this visit:
First we will obtain your written consent
Review the inclusion/exclusion criteria
Review simulator and complete simulator drive
Ask you to provide a urine sample for a urine drug screen
Females: our urine sample will be screened for pregnancy
Have you complete a survey about your driving experiences and demographic information
Dosing Visits:
These visits are spaced about one week apart and begin at 8 am. We will arrange third party transportation to bring you to our research facility.
Are you still interested in participating?
If YES, continue with Inclusion Criteria
Inclusion Criteria ~ General Questions
Before this list of questions is administered, please communicate the following:
There are several criteria that must be met for participation in this study. I will need to ask you several questions to determine your eligibility.
Proceed to Closing if an answer does not meet study criteria.
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General Questions Inclusion Criteria is met – proceed to Specific Cannabis Inclusion Questions or General Health Exclusion Criteria |
Specific Cannabis Inclusion Questions
Proceed to Closing if an answer does not meet study criteria.
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Specific Inclusion Criteria is met – proceed to General Health Exclusion Criteria |
1.1.1Overview1.1.2Before administering this list of questions, please communicate the following:2Because of pre-existing health conditions, some people are not eligible for participation in this study.3I need to ask you several health-related questions before you can be scheduled for a study session.4Your responses are voluntary and all answers are confidential.5You can refuse to answer any questions6No responses will be recorded. |
If a participant fails to meet one of the following criteria, proceed to the Closing
1) If the subject is female:
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File Type | application/msword |
Author | Nicole Hollopeter |
Last Modified By | dealmeig |
File Modified | 2013-09-15 |
File Created | 2013-02-07 |