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SOCRA Highlights

  • FDA Draft Guidance: Informed Consent Information

    The FDA has issued a draft guidance on Informed Consent. This guidance is intended to provide information to institutional review boards (IRBs), clinical investigators, and study sponsors about FDA's informed consent regulations. This guidance, when finalized, will supersede "A Guide to Informed Consent," issued in September 1998, by the Office of Health Affairs, FDA. To enhance human subject protection and reduce regulatory burden, the Department of Health and Human Services, Office for Human Research Protections and FDA have been actively working to harmonize the agencies' regulatory requirements and guidance for human subject research. This guidance document was developed as a part of these efforts. Read more...

  • 2015 Human Research Protections Conference Agenda Is Posted

    SOCRA is pleased to announce its 2015 Protecting Human Research Participants -
    Legal, Ethical and Practical Considerations Conference Agenda.

    The full Agenda is now posted.

    See the conference page for more details.

  • 2015 Pediatric Conference Agenda is Posted

    SOCRA's 2015 Pediatric Clinical Research Conference Agenda is now posted.

    See the conference page for more details.

  • SOCRA programs meet industry criteria for ICH GCP investigator site personnel training

    Clinical researchers who hold the SOCRA “CCRP,” Certified Clinical Research Professional designation, as well as those clinical researchers who complete specific SOCRA GCP courses, meet the minimum criteria for ICH GCP investigator site personnel training as identified by TransCelerate BioPharma member companies.

     

     

     

  • New Guidance: Electronic Source Data in Clinical Investigations

    This guidance addresses source data in clinical investigations used to fill the predefined fields in an electronic case report form (eCRF), according to the protocol. The guidance discusses the following topics related to electronic source data:

    • Identification and specification of authorized source data originators
    • Creation of data element identifiers to facilitate examination of the audit trail by sponsors, FDA, and other authorized parties
    • Ways to capture source data into the eCRF using either manual or electronic methods
    • Clinical investigator(s) responsibilities with respect to reviewing and retaining electronic data
    • Use and description of computerized systems in clinical investigations

     Read More

  • Revised FDA Compliance Program Guidance Manual

    We feel that you should be advised that FDA has issued (March 11, 2011) a revised Compliance Program Guidance Manual (CPGM) for FDA Staff, for inspections of Sponsors, Contract Research Organizations and Monitors (CP 7348.810). By reading this guidance, you will understand exactly what the FDA investigator will be seeking to verify. The guidance will help you to assure that your own practices, policies and procedures address all of the areas noted in Part 3 – Inspectional. Part 3 involves evaluation of the sponsor’s/CRO’s/monitor’s practices and procedures in order for FDA Investigators to determine compliance with applicable regulations.

    SoCRA’s Clinical Research conferences and workshops all address the regulations, guidance and practices involved in clinical trials through lecture, case studies, and discussion.

    SoCRA Annual Conference
    FDA Clinical Trial Requirements
    Site Management Workshops
    Clinical Research Monitoring Workshops
    Clinical Investigator Conference

  • AAHRPP’s Standard I.7.A.

    Click Here for AAHRPP’s clarification of their Standard I.7.A. pertaining to IRB approval of protocols for Phase 1 trials, specifically the issue of whether an IRB can approve advertising, recruiting, and screening procedures to begin prior to the end of the 30-day FDA review period or prior notification from FDA.

  • AAHRPP, The Association for the Accreditation of Human Research Protection Programs, announced on March 20, that it has accredited four more organizations.

    AAHRPP, The Association for the Accreditation of Human Research Protection Programs, announced on March 20, that it has accredited four more organizations.

    King Fahad Specialist Hospital-Dammam, Dammam, Saudi Arabia

    National Institutes of Health, Bethesda, Md. - The AAHRPP accreditation covers the NIH intramural research program, including NIH investigators at more than 20 institutes and centers on all NIH campuses.

    St. Jude Children’s Research Hospital, Memphis, Tenn.

    Taipei Medical University Hospital, Taipei, Taiwan

    AAHRPP provides accreditation for organizations that conduct or review human research and can demonstrate that their protections exceed the safeguards required by the U.S. government. To learn more, visit www.aahrpp.org.

  • FDA Requires New Informed Consent Elements

    The Food and Drug Administration (FDA) is amending the current informed consent regulations (21 CFR Part 50) to require that informed consent documents and processes for applicable drug (including biological products) and device clinical trials include a specific statement that clinical trial information will be entered into a databank. The databank referred to in this final rule is the clinical trial registry databank maintained by the National Institutes of Health/National Library of Medicine (NIH/NLM) which was created by statute. The submission of clinical trial information to this data bank also is required by statute. This amendment to the informed consent regulations is required by the Food and Drug Administration Amendments Act of 2007 (FDAAA) and is designed to promote transparency of clinical research to participants and patients.

     

    This rule is effective March 7, 2011. The compliance date of this final rule is March 7, 2012, for clinical trials that are initiated on or after the compliance date. See section III of the document for an additional explanation of the compliance date and required implementation of this final rule. See Federal Register: Informed Consent Elements for all details relating to this final rule.