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Safety Information Distribution

Safety Information pertains to the safety profile of study products (drug, vaccine, or device) and is intended to be used by the CRSs that are involved in DAIDS-supported studies. Information conveyed through the DAIDS RSC Safety Information Center (RIC) comes from drug company collaborators (Investigator Brochures and Package Inserts), from findings in DAIDS studies (IND Safety Reports and MedWatch Reports), from studies being conducted by the pharmaceutical company using the same study product as in a DAIDS-sponsored/supported study (Safety Memos), as well as publicly available safety information (Safety Alerts and Safety Notices).

Contact Information:


For questions about Safety Information Distribution:
Email Email: RIC@tech-res.com
Phone Phone: 1 (301) 897-1708
Fax Fax: 1 (800) 275-7619
Hours Hours: Monday – Friday (except holidays)
8:00 AM to 5:00 PM Eastern Time

Distribution of safety information is part of sponsor’s responsibilities in accordance with 21 CFR 312.32 and 21 CFR 312.55 as well as DAIDS policies and procedures. The DAIDS RIC processes and distributes safety information on behalf of DAIDS under the oversight of the DAIDS Safety and Pharmacovigilance Team (SPT).

Quick Links:

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Safety Information Distribution Types

Safety information is only distributed through a DAIDS-approved distribution list which includes CRS Leaders, Clinical Trial Units (CTUs) or Grant Principal Investigators (PIs), CRS and CTU Coordinators, and Investigators of Record (IoRs) at applicable CRSs, as well as the DAIDS Medical Officers (MOs) and relevant Operations Centers. For more detail on the various types of safety information, click the below links:


  • Package Insert

    Description: Information prepared by the manufacturer about an approved drug. It contains information on the indications and use of the drug, including contraindications, warnings, cautions, common adverse reactions, dosing and administration of the drug.

    Distribution Method: The package insert is posted on the DAIDS RSC website, and an e-mail notification is sent via the DAIDS-approved distribution list to CRSs that are using the approved drug in an active protocol. Notifications of updates to package inserts previously posted on the website are also sent to all applicable CRSs and include a comparison document.

  • Investigator’s Brochure

    Description: Information prepared by the manufacturer about a study agent under clinical development, either not yet approved by the FDA or being investigated for other use. The Investigator’s Brochure (IB) contains confidential and proprietary information, the distribution of which is restricted to DAIDS employees, contractors and grantees pursuant to a Confidential Disclosure Agreement (CDA) or Clinical Trial Agreement (CTA).

    Distribution Method: An e-mail notification is sent via the DAIDS-approved distribution list to CRSs that are using the study agent in an active protocol. A CD containing the IB as a PDF file along with a hard copy cover memo and an IB Receipt Confirmation sheet are sent via mail (FedEx) to the CRS Leaders at CRSs using the study agent. CTU PIs can receive the IB upon request. To learn how to request an IB, see the RIC FAQs.

  • IND Safety Report or MedWatch Report

    Description: A Safety Report is written by DAIDS and submitted to the FDA, notifying the agency that a serious adverse event (SAE) meeting reporting criteria has occurred on a study sponsored and/or supported by DAIDS. For studies conducted under an IND, IND Safety Reports are submitted as an amendment to the IND at the FDA. For studies that are not under an IND, a voluntary MedWatch report is sent to the FDA via MedWatch (the FDA Safety Information and Adverse Event Reporting Program; http://www.fda.gov/Safety/MedWatch/default.htm).

    Distribution Method: An e-mail notification containing a PDF copy of the report submitted to the FDA is sent via the DAIDS-approved distribution list to CRSs registered to active protocols using the study agent in the report.

  • Safety Memo

    Description: When a safety report is prepared and submitted to the FDA by a pharmaceutical company on a reportable event in a company sponsored study, DAIDS receives the safety report from company collaborators according to a CTA. DAIDS reviews the safety report and drafts a safety memo which accompanies the safety report and distributes both to CRSs that are using the study agent.

    Distribution Method: An e-mail notification containing a PDF copy of the report provided by the pharmaceutical company is sent via the DAIDS-approved distribution list to CRSs registered to active protocols using the study agent in the report.

  • Safety Alert

    Description: Safety information that DAIDS has determined to be of sufficient concern to warrant expedited distribution to CRSs. The information may be publically available, such as an FDA e-mail alert, or be a confidential communication from DAIDS and/or the manufacturer or pharmaceutical company collaborator.

    Distribution Method: An e-mail notification containing a PDF copy of the original material and/or official memo from DAIDS is sent via the DAIDS-approved distribution list to CRSs registered to active protocols using the study agent in the alert.

  • Safety Notice

    Description: Publically available safety information that DAIDS has determined to be of sufficient concern to warrant distribution to CRSs but which does not need to be distributed in an expedited timeframe. Examples of a Safety Notice include Dear Healthcare Professional letters or other FDA e-mail communications.

    Distribution Method: An e-mail notification containing a PDF copy of the original material and/or official memo from DAIDS is sent via the DAIDS-approved distribution list to CRSs registered to active protocols using the study agent in the notice.

  • Data Safety Monitoring Board (DSMB) Memo

    Description: A memo from the DAIDS Biostatistics Research Branch (BRB) containing the decision of the DSMB following a review of a specific protocol. The DSMB’s decision is summarized in the memo.

    Distribution Method: An e-mail notification containing a PDF copy of memo is sent via the DAIDS-approved distribution list to CRSs registered to the specific protocol.

  • Monthly Comprehensive Safety Distribution Report

    Description: A monthly report listing all safety information types that were distributed to CRSs by the DAIDS RSC Safety Information Center (RIC) during the previous twelve (12) month period.

    Distribution Method: An e-mail notification containing a cover memo and Excel spreadsheet is sent via the DAIDS-approved distribution list to all CRSs registered to active protocols.

For more information, see the Safety Information Distribution FAQs.


    SafetyInformation
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Copyright © DAIDS RSC. All rights reserved.
This project has been funded in whole or in part with Federal funds from the Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under contract No. HHSN272201000013C, entitled NIAID DAIDS Regulatory Support Center (RSC).

HomeWebsite User Feedback | Accessibility | Privacy Policy | Disclaimer
Copyright © DAIDS RSC. All rights reserved.
This project has been funded in whole or in part with Federal funds from the Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under contract No. HHSN272201000013C, entitled NIAID DAIDS Regulatory Support Center (RSC).