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Updated Site Information Questionnaire

Beginning Jan 1, 2010, Quorum Review IRB will only accept the most current version of the Site Information Questionnaire (F-039). This version is dated 09/07/09 and may be located in the "Forms" section of QuorumReview.com.

To ensure that Quorum's forms are as straightforward as possible to complete for sites and sponsors, Quorum staff performs a yearly review of the Site Information Questionnaire. Some of the significant changes are detailed below.

1. For Canadian sites, the TCPS portion of question 1 was built out to include checkboxes of possible reasons why TCPS may not be applied. Previously, if "NO" was checked, a written description was requested. Sites may still check "other" and describe if none of the checkboxes apply.



2. Language was clarified on question 3, Addresses to Appear on Consent Form(s). Quorum will include the primary facility address at the request of the site. If any other addresses should be included, Additional Site Information Questionnaires (F-038) should be submitted. At least one address must be included on the consent form.



3. Question 5, Compensation of Study Participants, was updated. Quorum now asks for the timing of compensation and the timing of reimbursement for travel and parking, in questions 5b and 5d, respectively.



4. The Human Research Participant Protection Training inquiry, question 8, was expanded to include examples of "self study or other training specific to human research participant protection" and also to request that that the Principal Investigator should complete some acceptable form of training before approval is granted.



5. In Question 15d, relating to non-english speaking participants, a second bullet point was added to part i indicating that the site should provide all study-related material in the participant's native language. A part ii was also added, which should be completed if non-english speaking participants will not be enrolled in the study.



6. Question 15e, regarding Legally Authorized Representatives, was built out to include parts ii and iii, which ask who will be allowed to act as a LAR and how this was confirmed.



7. There were language edits made to the bulleted safeguards listed under 15f (pregnant women), 15g (economically disadvantaged participants), and 15i (physically handicapped participants). Also, 15i was added, which asks whether a site will enroll from any other vulnerable population.



8. Other wording edits were made for clarity and consistency.

The Qualified Minimal Risk Site Information Questionnaire (F-053) was also updated, and beginning January 1, 2010, Quorum will only accept the most current version of this form as well. This version is dated 09/07/09 and may be located in the "Qualified Minimal Risk" section of QuorumReview.com.

Other forms that were also updated in September and October of 2009 include:

• Change in Principal Investigator Form (F-029)
• Change in Primary Facility Form (F-028)
• Serious Adverse Event Report (F-022)
• Additional Site Information Questionnaire (F-038)
• Institutional Jurisdiction Waiver Form (F-016)
• Site Status Report (F-040)
• Federal Funding Addendum (F-015)

For the current versions of these forms, please see the "Forms" section of QuorumReview.com. Quorum will continue to accept older versions of these forms. If you have any questions regarding these changes, please contact Quorum's Client Relations department at clientrelations@quorumreview.com, or at 206-448-4082.