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tmfrefmodel | main / TMF Reference Model Project Team
Members of the TMF Reference Model Project Team. Membership is open to anyone who is willing and has the time available to participate on a regular basis in one or more of the working teams of the project and agrees to the project's Intellectual Property Rights policy. Members who do not participate on a regular basis will be removed as a member. Once your membership request is accepted, please come back to this page to select the sub-team that you wish to join; these will be shown once you have logged in. If we do not receive a request within 4 weeks of joining, your membership will be terminated. *RULES:* We are very proud that this group contains uncluttered useful information and discussions. The rules are as follows: * No job postings at all * No recruitment * No company advertising, which includes company specific advertorial postings * No conference, webinar or blog advertising or linking * No advertising in responses to discussions There are plenty of places for people to advertise their companies, this just isn't one of them! But please feel free to share any interesting information or pose any challenges or questions around TMFs and eTMFs.
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306 Members, 74 Topics, Archives are visible to subscribers only, Restricted, Last Post:

Subgroups You Can Join

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Group is active and is accepting new members

  • tmfrefmodel | email / Electronic Mail
    Across industry, the issues associated with electronic mail (email) are widespread. These include how we interpret "relevant correspondence" for a trial/study; ensuring it is held or retained in an authoritative source; and producing email during a health authority inspection in a manner that is aligned with how the authority wishes to review it, accessible within the TMF. This workgroup will develop a position on and recommendations for relevant correspondence, including: * A position on determination of relevant correspondence; * Best practice  and considerations for filing methods and transference of email to an authoritative repository for longterm retention; * Best practice and considerations for producing emails during health authority inspections; and * Handling email attachments and embedded hyperlinks
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    18 Members, 9 Topics, Public Archives, Restricted, Last Post:
  • tmfrefmodel | Exchange-Business / Exchange Mechanism - Business Reviewers
    Exchange Mechanism Reviewers Group: For representatives of sponsor organizations and CROs who wish to review and provide comment on the draft Exchange Mechanism. This is NOT a group to simply get an early preview of the Exchange Mechanism. Group members will be expected to participate fully in the formal review of draft specifications and other supporting materials.
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    48 Members, 39 Topics, Archives Viewable By Parent Group, Restricted, Last Post:
  • tmfrefmodel | Exchange-Vendor / Exchange Mechanism Vendor Reviewers
    Exchange Mechanism - Vendor reviewers – For representatives of companies that offer a commercial eTMF product who wish to review and provide technical comment on the draft Exchange Mechanism. This is NOT a group to simply get an early preview of the Exchange Mechanism. Group members will be expected to participate fully in the formal review of draft specifications and other supporting materials.
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    25 Members, 11 Topics, Archives Viewable By Parent Group, Restricted, Last Post:
  • tmfrefmodel | ccb / Change Control Board
    This group is for members of the Change Control Board for the TMF Reference Model. Please do not submit requests to join this group.
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    14 Members, 158 Topics, Archives Viewable Only By Members, Restricted, Last Post:
  • tmfrefmodel | devices / Devices Sub-team
    Sub-team for trials using medical devices / diagnostics. Based on applicable guidance and best practice, this Group will identify existing artifacts that are specifically applicable to trials using medical devices and diagnostics. In addition, they will identify example subtypes and any artifacts that are not currently included in the Reference Model. They will also identify where changes to the text within the Model could be improved to facilitate adoption for device/diagnostic trials.
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    23 Members, 42 Topics, Archives Viewable By Parent Group, Restricted, Last Post:
  • tmfrefmodel | exchange / Exchange Mechanism Sub-group
    Sub-group for the Exchange Mechanism group
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    12 Members, 62 Topics, Archives Viewable By Parent Group, Restricted, Last Post:
  • tmfrefmodel | j-gcp / Japan GCP Adaptation
    Assess ways of adapting the TMF Reference Model to better align with Japanese GCP requirements. Specific deliverables to be identified and agreed.
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    22 Members, 5 Topics, Archives Viewable By Parent Group, Restricted, Last Post:
  • tmfrefmodel | nis / Non-interventional Studies
    Sub-group of the TMF Reference Model Project for the Non-Interventional Studies Team. Based on relevant guidance and best practice, this Group will identify existing Reference Model artifacts that would be expected for  non-interventional studies (including observational / registry studies), and any additional artifacts or subtypes that are not already included in the Model.
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    19 Members, 118 Topics, Archives Viewable By Parent Group, Restricted, Last Post:
  • tmfrefmodel | sme / Combined SME Team
    Combined group for all 11 SME zone team members. *Please do NOT ask to join this group. Instead, join one or more of the individual zone teams. Members of individual SME teams (zones 1-11) will be automatically added to this group.*
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    53 Members, 6 Topics, Archives Viewable By Parent Group, Restricted, Last Post:
  • tmfrefmodel | subtype / Artifact Subtypes
    Working group to define artifact subtypes (sub-artifacts). The current version of the TMF Reference Model includes a small number of example artifact subtypes (or sub-artifacts). This Group will propose additional subtypes that are commonly used across industry. They will also develop clear guidance on the purpose and use of subtypes within the Reference Model.
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    59 Members, 87 Topics, Archives Viewable By Parent Group, Restricted, Last Post:
  • tmfrefmodel | survey / Survey Working Group
    Sub-group for Survey Working Group. This Group is dormant for significant periods of time but requires effort when the TMF Reference Model survey is launched. The Group review and revise the survey questions, publish the survey online, and then analyse and publish the results.
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    22 Members, 6 Topics, Archives Viewable By Parent Group, Restricted, Last Post:
  • tmfrefmodel | tmf-plan / TMF Management Plan
    Sub-group of the TMF Reference Model Project for the TMF Management Plan Team. *Not currently taking on additional team members. Please do NOT send a request to join this team.*
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    12 Members, 27 Topics, Archives Viewable By Parent Group, Restricted, Last Post:
  • tmfrefmodel | zone01 / Zone 01 Trial Management Subject Matter Experts
    Sub-group for Zone 01 Trial Management Subject Matter Experts. This Group will review Change Requests on an ad hoc basis that are pertinent to the specified zone of the Reference Model and provide their recommendation to the Change Control Board for accepting or rejecting the proposed Change Request. For each change accepted, the Group will identify the change as a Major, Minor or Maintenance change. The Group will also participate in any general Reference Model review activities.
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    25 Members, 6 Topics, Archives Viewable By Parent Group, Restricted, Last Post:
  • tmfrefmodel | zone02 / Zone 02 Central Trial Documents Subject Matter Experts
    Sub-group for Zone 02 Central Trial Documents Subject Matter Experts. This Group will review Change Requests on an ad hoc basis that are pertinent to the specified zone of the Reference Model and provide their recommendation to the Change Control Board for accepting or rejecting the proposed Change Request. For each change accepted, the Group will identify the change as a Major, Minor or Maintenance change. The Group will also participate in any general Reference Model review activities.
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    13 Members, 8 Topics, Archives Viewable By Parent Group, Restricted, Last Post:
  • tmfrefmodel | zone03 / Zone 03 Regulatory Subject Matter Experts
    Sub-group for Zone 03 Regulatory Subject Matter Experts. This Group will review Change Requests on an ad hoc basis that are pertinent to the specified zone of the Reference Model and provide their recommendation to the Change Control Board for accepting or rejecting the proposed Change Request. For each change accepted, the Group will identify the change as a Major, Minor or Maintenance change. The Group will also participate in any general Reference Model review activities.
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    10 Members, 10 Topics, Archives Viewable By Parent Group, Restricted, Last Post:
  • tmfrefmodel | zone04 / Zone 04 IRB/IEC Subject Matter Experts
    Sub-group for Zone 04 IRB/IEC Subject Matter Experts. This Group will review Change Requests on an ad hoc basis that are pertinent to the specified zone of the Reference Model and provide their recommendation to the Change Control Board for accepting or rejecting the proposed Change Request. For each change accepted, the Group will identify the change as a Major, Minor or Maintenance change. The Group will also participate in any general Reference Model review activities.
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    15 Members, 4 Topics, Archives Viewable By Parent Group, Restricted, Last Post:
  • tmfrefmodel | zone05 / Zone 05 Site Management Subject Matter Experts
    *THIS TEAM IS OVER-SUBSCRIBED - PLEASE DO NOT REQUEST TO JOIN AS IT CANNOT ACCEPT ANY MORE MEMBERS.* ---------------------------------------------------------------------------------------------------- Thanks for your interest. Sub-group for Zone 05 Site Management Subject Matter Experts. This Group will review Change Requests on an ad hoc basis that are pertinent to the specified zone of the Reference Model and provide their recommendation to the Change Control Board for accepting or rejecting the proposed Change Request. For each change accepted, the Group will identify the change as a Major, Minor or Maintenance change. The Group will also participate in any general Reference Model review activities.
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    16 Members, 3 Topics, Archives Viewable By Parent Group, Restricted, Last Post:
  • tmfrefmodel | zone06 / Zone 06 IP & Trial Supplies Subject Matter Experts
    Sub-group for Zone 06 IP & Trial Supplies Subject Matter Experts. This Group will review Change Requests on an ad hoc basis that are pertinent to the specified zone of the Reference Model and provide their recommendation to the Change Control Board for accepting or rejecting the proposed Change Request. For each change accepted, the Group will identify the change as a Major, Minor or Maintenance change. The Group will also participate in any general Reference Model review activities.
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    8 Members, 5 Topics, Archives Viewable By Parent Group, Restricted, Last Post:
  • tmfrefmodel | zone07 / Zone 07 Safety Reporting Subject Matter Experts
    Sub-group for Zone 07 Safety Reporting Subject Matter Experts. This Group will review Change Requests on an ad hoc basis that are pertinent to the specified zone of the Reference Model and provide their recommendation to the Change Control Board for accepting or rejecting the proposed Change Request. For each change accepted, the Group will identify the change as a Major, Minor or Maintenance change. The Group will also participate in any general Reference Model review activities.
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    7 Members, 5 Topics, Archives Viewable By Parent Group, Restricted, Last Post:
  • tmfrefmodel | zone08 / Zone 08 Central & Local Testing Subject Matter Experts
    Sub-group for Zone 08 Central & Local Testing Subject Matter Experts. This Group will review Change Requests on an ad hoc basis that are pertinent to the specified zone of the Reference Model and provide their recommendation to the Change Control Board for accepting or rejecting the proposed Change Request. For each change accepted, the Group will identify the change as a Major, Minor or Maintenance change. The Group will also participate in any general Reference Model review activities.
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    9 Members, 14 Topics, Archives Viewable By Parent Group, Restricted, Last Post:
  • tmfrefmodel | zone09 / Zone 09 Third Parties Subject Matter Experts
    Sub-group for Zone 09 Third Parties Subject Matter Experts. This Group will review Change Requests on an ad hoc basis that are pertinent to the specified zone of the Reference Model and provide their recommendation to the Change Control Board for accepting or rejecting the proposed Change Request. For each change accepted, the Group will identify the change as a Major, Minor or Maintenance change. The Group will also participate in any general Reference Model review activities.
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    9 Members, 5 Topics, Archives Viewable By Parent Group, Restricted, Last Post:
  • tmfrefmodel | zone10 / Zone 10 Data Management Subject Matter Experts
    Sub-group for Zone 10 Data Management Subject Matter Experts. This Group will review Change Requests on an ad hoc basis that are pertinent to the specified zone of the Reference Model and provide their recommendation to the Change Control Board for accepting or rejecting the proposed Change Request. For each change accepted, the Group will identify the change as a Major, Minor or Maintenance change. The Group will also participate in any general Reference Model review activities.
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    13 Members, 24 Topics, Archives Viewable By Parent Group, Restricted, Last Post:
  • tmfrefmodel | zone11 / Zone 11 Statistics Subject Matter Experts
    Sub-group for Zone 11 Statistics Subject Matter Experts. This Group will review Change Requests on an ad hoc basis that are pertinent to the specified zone of the Reference Model and provide their recommendation to the Change Control Board for accepting or rejecting the proposed Change Request. For each change accepted, the Group will identify the change as a Major, Minor or Maintenance change. The Group will also participate in any general Reference Model review activities.
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    8 Members, 10 Topics, Archives Viewable By Parent Group, Restricted, Last Post: