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Quorum Announces Safety Acknowledgment Changes

In response to feedback from our customers, Quorum is pleased to announce that sites in new studies submitted to Quorum will now receive "safety start-up letters" as part of the IB and IND Study-wide Safety Acknowledgement Service that Quorum currently offers.

On the Central Study Questionnaire, Quorum offers a Study-Wide Safety Acknowledgment Service. If this option is chosen, Quorum provides formal acknowledgments to all sites for events such as IND safety reports (external adverse event reports) and Investigator Brochures (or other protocol-level product information, including Package Inserts and Device Manuals) that have been submitted to Quorum. If a sponsor or CRO selects Quorum's Study-wide Safety Acknowledgment Service (available for IND safety reports, IBs, or both), when one of these events occurs a formal acknowledgment will be issued to all sites in the study.

Researchers have indicated to Quorum that some sites would like a summary of the INDs and IB revisions that have been issued prior to the sites' enrollment in the study. In response, Quorum has initiated this new "safety start-up letter" process.

Below is a list of questions that you may have about this process.

Tell me more about the "start-up letter" service—what does this mean?
On the Central Study Questionnaire, study contacts may continue to choose their safety acknowledgment preference.

  • If the study contact chooses both the IB and IND Study-wide Safety Acknowledgment Service of delivery to sites, sites that submit to Quorum will receive a “start-up letter” containing acknowledgment of the most current IB and of any INDs that were received by Quorum for the study prior to site start-up.
  • If the study contact chooses the IB Study-wide Safety Acknowledgment service only, sites that submit to Quorum will receive a "start-up letter" containing acknowledgment of the most current IB that was received by Quorum for the study prior to site start-up.
  • If the study contact chooses the IND Study-wide Safety Acknowledgment Service only, sites that submit to Quorum will receive a "start-up letter" containing acknowledgment of any INDs that were received by Quorum for the study prior to site start-up.
  • If the study contact chooses the "Sponsor Distribution of Acknowledgment letters" option for both IBs and INDs, start-up letters will not be issued to sites.

Will the "start-up letter" list all previously reviewed IBs and INDs?
The letter will identify the most current IB, as well as list all INDs that have been received by Quorum prior to site start-up.

Is there an additional charge for this service?
These letters will be billed at the standard "Study-wide Safety Acknowledgment Service" rates.

Will this affect my existing study with Quorum Review?
No. The study-wide safety acknowledgement service for all existing studies will remain as it currently stands. New sites in these existing studies will not receive "safety start-up" letters.

If you have additional questions, please contact Quorum's Client Relations department. We hope that you find this service to be a helpful new addition to Quorum's service offerings.