Main Group

TMF Reference Model Project Team
*PLEASE DO NOT REQUEST TO JOIN IF YOU ARE NOT WILLING AND AVAILABLE TO ACTIVELY PARTICIPATE IN A WORKING GROUP.* 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 and click on the Subgroup menu option 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*. You are just wasting your time and our time if you request to join this group but then do not follow-up and join a sub-team! *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.
Created:
336 Members, 124 Topics, Archive is visible to members only, Restricted, Last Post:

Subgroups You Can Join

OPEN

Group is active and is accepting new members

  • 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.
    Created:
    48 Members, 42 Topics, Archives Viewable Only By Members, Restricted, Last Post:
  • 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.
    Created:
    24 Members, 11 Topics, Archives Viewable Only By Members, Restricted, Last Post:
  • 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.
    Created:
    25 Members, 223 Topics, Archives Viewable Only By Members, Last Post:
  • Exchange Mechanism Sub-group
    Sub-group for the Exchange Mechanism group
    Created:
    12 Members, 62 Topics, Archives Viewable Only By Members, Last Post:
  • 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.
    Created:
    23 Members, 120 Topics, Archives Viewable Only By Members, Last Post:
  • 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.
    Created:
    22 Members, 6 Topics, Archives Viewable Only By Members, Last Post:
  • 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.
    Created:
    27 Members, 6 Topics, Archives Viewable Only By Members, Last Post:
  • 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.
    Created:
    18 Members, 12 Topics, Archives Viewable Only By Members, Last Post:
  • 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.
    Created:
    11 Members, 10 Topics, Archives Viewable Only By Members, Last Post:
  • 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.
    Created:
    18 Members, 6 Topics, Archives Viewable Only By Members, Last Post:
  • 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.
    Created:
    18 Members, 4 Topics, Archives Viewable Only By Members, Last Post:
  • 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.
    Created:
    10 Members, 6 Topics, Archives Viewable Only By Members, Last Post:
  • 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.
    Created:
    8 Members, 5 Topics, Archives Viewable Only By Members, Last Post:
  • 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.
    Created:
    10 Members, 16 Topics, Archives Viewable Only By Members, Last Post:
  • 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.
    Created:
    11 Members, 5 Topics, Archives Viewable Only By Members, Last Post:
  • 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.
    Created:
    20 Members, 26 Topics, Archives Viewable Only By Members, Last Post:
  • 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.
    Created:
    11 Members, 10 Topics, Archives Viewable Only By Members, Last Post:
  • 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.*
    Created:
    53 Members, 6 Topics, Archives Viewable By Parent Group, Restricted, Last Post: