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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  • FDA Draft Guidance: Informed Consent Information

    The FDA has issued a draft guidance on Informed Consent.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...

  • 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 (noted below), meet the minimum criteria for ICH GCP investigator site personnel training as identified by TransCelerate BioPharma member companies.

    SOCRA education programs (in addition to “CCRP” certification) currently recognized by the companies listed below as appropriate GCP training for clinical trial site personnel include:

     

    SoCRA “CCRP” Certification Preparation & GCP Review Course Scheduled for; 

    • March 17, 2014 in Singapore
    • May 27, 2014 in San Francisco
    • June 12, 2014 in Hollywood, Florida
    • July 25, 2014 in Vancouver, British Columbia, Canada
    • September 17, in Orlando Florida
    • Plus additional locations to be posted on our web site

     

    Clinical Site Coordinator/ Manager Workshop  GCP for Coordinators, Research Associates, Study Nurses, Site Managers  Scheduled for; 

    • April 3 and 4, 2014 in Vancouver, British Columbia, Canada   
    • July 10 and 11, 2014 in Chicago, IL 
    • November 14 and 15, 2014 in Nashville, Tennessee

     

    Conducting Clinical Trials in Canada Scheduled for;

    • May 8 and 9, 2014 in Toronto, ON, Canada

     

    Clinical Investigator GCP & Trials Management Conference  for Clinical Investigators and Key Research Staff Scheduled for;

    • December 4 and 5, 2014, in Las Vegas, Nevada

    AbbVie www.abbvie.com

    Allergan www.allergan.com

    Astellas www.astellas.com

    AstraZeneca www.astrazeneca.com

    Biogen Idec  www.biogenidec.com

    Boehringer Ingelheim  www.boehringer-ingelheim.com/

    Bristol-Myers Squibb www.bms.com

    Cubist  www.cubist.com

    EMD Serono www.emdserono.com

    Forest Laboratories, Inc.  www.frx.com

    GlaxoSmithKline www.gsk.com

    Lilly  www.lilly.com

    Johnson & Johnson  www.jnj.com

    Medgenics  www.medgenics.com

    Shionogi  www.shionogi.com

    Pfizer  www.pfizer.com

    Roche  www.roche.com

    Sanofi  www.sanofi.com

    UCB  www.ucb.com

  • 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.