IBC TMF Filing

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    • #2795
      Lindsay Grier

      I work for a CRO that is beginning it’s first gene therapy trial. We are all new to gene therapy – and working with Institutional Biosafety Committees. How do people in your company file documentation for the IBC? The same as the IRB, just add a reference model subtype for IBC? This is the direction I am leaning, but the TMF Reference Model does not mention IBCs. Thank you!

    • #2796
      Karen Williams

      I would think you could still file the documents under the IRB/IEC section
      because I believe IBC functions as a oversight, compliance and approval with members function in the same capacity as the major IRBs or Local IRBs (more local than central IRBs) as long as there members approval schedules You would file them as a local IRB. Below are some requirements of an IBC at UNC Hospital. I hope this helps

      Function of the IBC
      The IBC is responsible for the oversight, administration, and review of UNC‐CH Lab policies and projects involving research with recombinant or synthetic nucleic acid molecules and hazardous biological materials that may pose safety, health, or environmental risks. To this end, the IBC assists and advises Principal Investigators and other researchers in meeting their responsibilities to ensure that the biological aspects of the research are conducted in a safe manner using established biosafety standards, principles and work authorization. Safe research includes worker safety, public health, agricultural and environmental protection, ethics, and compliance with applicable biosafety standards and UNC‐CH Policies.

      The IBC will investigate and report any significant problems with or violations of the NIH Guidelines and any significant research‐related accidents or illnesses involving recombinant genomic materials to the Principal Investigator, the Biological Safety Officer, the Department Chair, and the NIH Office of Biotechnology Activities (OBA) within 30 days, unless the IBC determines that the Principal Investigator or lead researcher has already filed a report.
      Structure of the IBC
      A broad array of available research and regulatory expertise is important for the IBC given the range of recombinant DNA research that the committee reviews. The NIH requires that the IBC have at least five members selected who collectively have the experience, expertise, and capability needed to assess the breadth and safety of recombinant and synthetic nucleic acid molecules as well as other biological materials, agents, and organisms as needed to identify any potential risks to workers, public health, or the environment.

      IBC Charter Approval
      IBC members will review proposed amendments to this charter during a regularly scheduled meeting of the committee and vote on acceptance of each amendment.

    • #2797
      Kathie Clark

      Wouldn’t these fall under committees? There are a number of artifacts in this zone and section:

      01 Trial Management 01.03 Trial Committee 01.03.01

      For example, the Committee Process artifact says:

      To describe the purpose and mode of operation/manner of working of the Independent Trial Committee, which may be established by the sponsor to assess at intervals the progress of a clinical trial, the safety data and the critical efficacy endpoints and to recommend to the sponsor whether to continue, modify or stop a trial. To describe in advance the decision-making process of the Committee that will evaluate key trial events (e.g. endpoints).

      Committee Types may include but not limited to: DMC, DSMB, National, Steering, Scientific, Internal DMC, Device, Dose Escalation, Safety Evaluation, Adjudication, Clinical Events Coordination. These may be used as sub-artifacts or metadata. Applies to all Committee artifacts

    • #2798
      Karen Williams

      Yes, still under the IRB section and filed in other committee as you would a local IRB

      IRB or IEC and other Approvals 04.02 Other Committees 04.02.02 Other Approvals “Scientific Committee Approval
      Institutional Committee Approval
      Veterans Affair Committee Approval
      Radiation Committee Approval
      Financial Committee Approval
      Data Protection Committee Approval
      Biobank Committee Approval
      Other Approvals: Other” 04.02.02 Other Approvals X X Approval date

    • #2799
      Karen Williams

      Will these documents be filed under trial level or site level, That will basically determine which committee it will be filed under.

    • #2800
      Karen Williams

      Will these documents be filed under trial level or site/country level, That will basically determine which committee it will be filed under.

    • #2801
      Lindsay Grier

      This documentation will be filed under site level. Things like the IBC Roster (each one is specific to each site), IBC drafted site-specific SOP, IBC Approval, and IBC Institutional Agreement with the PI (signature page).

    • #2802
      Karen Williams

      So you would file your documents receive within the other committee submissions or approvals. sections 4.1 and 4.2. accordingly.


    • #2803
      Lindsay Grier

      Thanks! Thank you both for your help! 🙂

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