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Quorum's New Streamlined Forms for Reporting IND Safety ReportsWith the growth of large multi-site studies, IRBs and researchers often find themselves inundated with IND Safety Reports reporting adverse events from around the world. In order to support safety monitoring coherently, Quorum launched new policies, forms, and guidelines to clarify the types of safety data that are relevant to an IRB. As an IRB, Quorum's focus is to collect information about unanticipated problems that involve risk to subjects or others. Quorum's goal is to collaborate with sites to protect research participants while streamlining how we do so. In order to achieve our goal Quorum's forms now:
A number of researchers have asked for more information about Quorum's new policies. The most frequently asked questions are listed below. Is it true that a researcher does not have to submit each and every IND Safety Report to Quorum? Yes, it is true that Quorum does not have to receive every IND Safety Report circulated in the course of a study. Under federal regulations an IRB has a very limited role with respect to data monitoring. Even though a drug study sponsor is required to collect reports of all adverse events, an IRB is required only to ensure prompt reporting of "unanticipated problems that involve risk to subjects or others." See 21 CFR § 312.33(b); 21 CFR § 312.32(c); 21 CFR § 312.64(a); 21 CFR 56.108(b)(1). The Office of Human Research Protections ("OHRP") emphasized these concepts in recent draft guidance. OHRP noted that "unanticipated problems" consist of a small subset of the total number of adverse events experienced during a study. Dr. David LePay of the FDA indicated at the meeting of the Secretary's Advisory Committee for Human Research Protections ("SACHRP") of November 1, 2005 that the FDA is also working on guidance and is working towards a position consistent with OHRP's. To read the OHRP draft guidance in its entirety, please visit www.hhs.gov/ohrp/requests/com101105.html, or read more about the OHRP guidance in an article from our last Quorum Forum. Consistent with these regulations and guidance, Quorum asks that sites and/or sponsors submit only those IND Safety Reports that describe events that, in the reporter's judgment:
We are not asking an investigator to assess anything beyond the scope of observations made at his or her site. What if my sponsor or site has policies that require that every IND Safety Report be submitted to the IRB? We understand that some sponsors and sites have internal policies that require researchers to submit all IND Safety Reports to the IRB. These researchers should feel free to submit all such reports as follows:
Please use our new "Safety Information and Unanticipated Problem Cover Page" when submitting IND safety reports to Quorum. What if I am unsure as to whether I should submit a particular IND Safety Report to the IRB? If the investigator is unsure as to how to assess a report, the investigator is welcome to err on the side of caution and submit the report to Quorum. We also encourage the investigator to refer to the Quorum Handbook or Quorum's Safety Information and Unanticipated Problems Reporting Guidelines (both located on our website at www.quorumreview.com) for assistance. Finally, you can contact us at (206) 448-4082. What if I don't submit a coversheet with the IND Safety Report... or what if I submit my own coversheet? Quorum encourages sites to submit Quorum's coversheet to assist the IRB in its assessment and to reduce the need for follow-up telephone calls. Nevertheless, Quorum will process an IND Safety Report even if it is submitted without Quorum's coversheet. If you submit an IND Safety Report without any coversheet or with your own version, please expect to receive the following:
How does Quorum acknowledge the receipt of IND Safety Reports? Quorum provides sites with a "standard acknowledgment" for all safety information submitted to the IRB. This acknowledgement consists of a copy of the first page of the information submitted with a "Quorum received" stamp on it. Sites should keep this stamped copy of the first page for their records. Quorum also sends a cover memo with each standard acknowledgement. This cover memo has additional information about safety reporting and is informational only. Please note - if the cover memo indicates that the report was submitted with insufficient information or missing the cover page, resubmission is not required unless the researcher believes the report qualifies as an unanticipated problem. Where are the safety reporting forms located on Quorum's website? Quorum has created additional content for the website (www.quorumreview.com) dedicated solely to safety reporting forms and guidelines. This content can be reached from the website's home page by using either the "sponsor" tab or the "investigator" tab located at the top of the page. Navigate to the "General Forms and Guidelines-by Topic" section and select the Safety Reporting link. The area includes forms, guidelines and a slide show explaining Quorum's policies. Where can I find more information? For further assistance in defining an "unanticipated problem involving risk to participants or others" - or for more information about Quorum's safety information reporting guidelines - please refer to the Quorum Handbook or Quorum's Safety Information and Unanticipated Problems Reporting Guidelines (both located on our website at www.quorumreview.com). You also are welcome to contact us through the website or by calling us at (206) 448-4082. |
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