| 1. |
How do I get on the list to receive safety information such as Safety Reports, IB and Package Insert notices? |
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The RSC Safety Information Center (RIC) cannot add recipients for safety information that do not have a role defined by the DAIDS-approved distribution algorithm. Per DAIDS procedures, the safety information is distributed to CTU Principal Investigators, CRS Site Leaders, Investigators of Record and CTU/CRS Coordinators only, as identified in Master Contacts. If individuals assigned to these roles at the site change, the Office of Clinical Site Oversight (OCSO) representative for that site will need to be contacted for that change to be made. Any personnel changes to authorized recipients for NICHD funded sites need to be made through Westat.
The distribution of safety information is drug and study site specific so it is not possible for the RSC to add individuals who are not associated with the roles identified above. There are, however, ways in which rules can be created in Microsoft Outlook which will automatically forward documents received from a particular address (such as the RSC Safety Information Center) to others at your site. Other email systems have similar capabilities. The IT Support group at your institution can probably assist you. Here are a few helpful links for Microsoft Outlook to create rules which will assist you in the distribution of the emailed documents within your site:
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| 2. |
Is there any way to separate protocols in development from active protocols for safety report distribution? |
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The DAIDS distribution algorithm for safety reports (Safety Memos, IND Safety Reports and MedWatch) includes protocols that are in development. This enables DAIDS to provide relevant safety information to the DAIDS Medical Officers and Protocol Team during the development of new protocols. Per DAIDS, until the site is registered to a protocol, the site is not responsible for sending reports related to the protocol to the Institutional Review Board (IRB). To avoid any confusion, we will separate the distribution of these documents, providing relevant information for protocols under development using an independent distribution. |
| 3. |
Can I receive an Investigator’s Brochure electronically via e-mail? |
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Due to the confidential nature of the Investigator Brochure, it cannot be provided electronically as an email attachment. Per DAIDS procedures, Investigator’s Brochures are sent as a PDF on a CD-Rom. |
| 4. |
Do I need submit this safety information to my IRB? |
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DAIDS can not dictate to the sites what information needs to be submitted to individual IRBs. |
| 5. |
How do I get safety information that was distributed prior to my site registration date? |
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DAIDS has indicated that the sites are only required to have on file the safety reports that have been distributed since their registration to the protocol. The sites are not required to have all of the reports which have been distributed since the protocol was initiated. |
| 6. |
What changes can I look for once a Package Insert update has been posted on the RSC website? |
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The package Insert (PI) is obtained directly from the drug company. As such, the RSC cannot comment on any changes in the document provided by the drug company. The newer PIs now have a “highlights of prescribing information” section at the beginning of the PI. Included in the highlights section is a listing of sections that have “recent major changes”. |
| 7. |
In the cover memo for Safety Memos, it states that the information must be sent to the IRB within 30 days. Our IRB policy has a different timeframe. Whose instructions should we follow? |
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DAIDS has indicated that the site should follow local IRB/EC policy in submitting the safety reports as specified in the cover memo. If the IRB requires that the reports be submitted within a different timeframe, the site should follow the requirements of their IRB. |
| 8. |
How do I handle IRB questions regarding an adverse event distributed in a Safety Memo? |
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An adverse event distributed as part of a Safety Memo is an event that has occurred in a drug company sponsored trial. If a site receives a question regarding an event that was distributed by DAIDS as a Safety Memo, contact the RSC Safety Information Center (RIC) with the question. RIC will forward the question to the relevant drug company. The site should receive a response directly from the drug company. |
| 9. |
For Package Inserts, will all prescribing information for human drug and biological products be required to conform with the new content and format requirements? |
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No. The new requirements only apply to new and recently approved prescription drugs. This includes those that were approved on or after the effective date of the final rule, drugs that have been approved in the 5 years prior to the effective date of the final rule, and older drugs for which there is a major change in the prescribing information (e.g., approval of a new use). Many older approved drug products are not required to meet the content and format revisions, though they may have to provide additional patient information. They can voluntarily revise their prescribing information.(This information was taken directly from the FDA’s website. The Final Rule was published in January 2006 and became effective on June 30 2006.)
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/LawsActsandRules/ucm084244.htm |