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Introducing Our New Site Information Questionnaire (SIQ)After gathering feedback from both sites and sponsors about our current submission form Quorum has redesigned our Site Information Questionnaire (SIQ) to make the site submission process easier. The form is shorter and the updated questions make it simpler for sites to complete. This article summarizes the most significant changes to the form. Please call the Site Support Team at (206) 448-4082 if you have additional questions or feedback about the new SIQ. Informed Consent To eliminate the need for SOP attachments, Quorum has incorporated expected safeguards for the informed consent process into the SIQ. The site must only affirm that they will uphold the expected safeguards listed under each population requiring consent. (See example below) If the site will not follow the expected safeguards, Quorum will require a letter of explanation. Quorum anticipates that this system will allow for increased transparency between board expectations and site practice.  Audit Documentation Quorum has reduced its reporting requirements for past FDA or OHRP audit reviews for principal investigators. The new SIQ asks for any audit information that has taken place in the past 3 years (no longer 7 years). We have also removed the question inquiring about audit information for sub-investigators/site facilities. These changes will allow Quorum’s board to focus on the most recent and relevant information during a site’s review. Drug/Device Storage This question has been re-written to better help sites identify what study materials require secure storage – including but not limited to placebo, approved drugs/devices and approved comparators. (see below)  **Remembering Attachments** Quorum has taken extra steps to provide reminders throughout the SIQ to indicate when separate attachments may be necessary (see example above). These bolded sub-headings are listed beneath each question that may require an additional attachment dependent on the sites response. We hope that these reminders will assist sites in sending complete submissions to the board. Compensation Quorum has redesigned the compensation section to allow sites to choose from 3 options for payment. Options are available for sites that will not compensate for the study, sites that will compensate the same amount per visit for the entire study and for those sites whose compensation will vary for each visit. For studies that have a complex compensation plan Quorum is encouraging the use of an attachment to describe the plan. If the site or sponsor does not have a compensation template already in development they may utilize Quorum’s new compensation template.  |
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