Completed patient questionnaires

[Leanne Bone]

Where do I file completed patient questionnaires? Should these be included in the TMF? Thanks for you help!

[Janna Gonzalez]

Hi Leanne,

I think this the correct Zone-
Example of documents:

“Example of Documents,
Patient Pre-Screening Call/ Telephone Script
Subject Questionnaire, review and approval any summary of changes
Patients Dose Dairy filled out by site coordinator or other staff

02 Central Trial Documents 02.02 Subject Documentation 02.02.02 Subject Questionnaire To capture specific subject related information through a series of questions (blank forms / templates) “Subject Questionnaire
Subject Questionnaire Review and Approval
Subject Questionnaire Summary of Changes
”
Hope this helps!
Janna

[Author]

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