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Changes to Central Study Questionnaire
Most of the changes to the Central Study Questionnaire (CSQ) are to accommodate Quorum’s expansion to review Canadian research. In addition, we have included some other notable additions:
– No hard copies for Secondary Contact (Question 2): This is for a study contact who wants to be involved in the study but does not need hard copies of all approval documents. Contacts listed here with the “No hard copies” box checked will receive a Quorum Web Portal account, but will not receive “cc” copies of IRB documents.
– Language changes (Questions 5, 6B and 6D): We have revised language in these questions for clarity questions and additional guidance
– State Law language (Question 6C): Quorum now can prepare and deliver consent forms tailored to specific states’ regulations. With the choices offered in the State Law questions, sponsors and CROs can communicate their preferences for preparing state law-compliant consent forms:
- Prepare one consent form for all sites. This version will not include any state-specific language, and sites in states with specific requirements will need to submit requests for a unique consent form
- Prepare a consent form specifically for California sites, and provide the standard language for all remaining sites.
- Prepare consent forms for other states’ requirements
- Prepare one consent form for all sites that is compliant with the state of California. (Generally speaking, California has the most stringent privacy and reporting requirements).
Please Contact Us with any questions regarding our new Central Study Questionnaire.
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