groups » Trial Management » Review of Downloadable Tools & Templates for Clinical Research

Hi,

We are planning to update and review the tools and templates provided on the Global Health Trials website to facilitate Clinical Research preparation and conduction (See the “Resources > Tools and Templates” section).

We would thus be happy to hear from your experience if you have used any of the currently available documents. In addition, do not hesitate to tell us if you were missing some specific resources that we could add here in the future…

Looking forward to your feedback,
Amelie

Reply

  • GHN_Editors The Editorial Team 30 Oct 2015

    Dear Patience

    thank you - good question! One of our collaborators has said:

    I would suggest documenting the process for the archiving of any trial data in the Data Management Plan. There should also be an overarching trial Archiving SOP which can then be referenced to in the Data Management Plan.

    Current experience has suggested that archiving the actual database may be expensive and this would not be feasible for some. However the archiving output generated by InferMEd from the MACRO database is fully compliant with FDA CRF 21 Part 11 requirements. So, if the FDA were to ask to see the database following trial closure, I would be pretty confident this document would suffice.

    Obviously copies of all the final CRFs, data extractions would be available too, along with all other trial Data SOPS and IDMC documents.

    There are some documents and information on the Data Management area of The Global Health Network, which you can access here: https://globalhealthdatamanagement.tghn.org/data-dudes/tools-templates/

  • patiencetubie Patience Tubie 29 Oct 2015

    Hello,
    I am was wondering if anyone has a Data Archival Plan to share
    regards,
    Patience Tubie

  • omymahr Omymah Zain Alddin Abed AlRaheem Al Rajabi 8 Feb 2015

    Tool validation
    I developed a new psychometric paper in midwifery profession titled
    Factors influencing women's attitudes towards midwifery: Tool Validation
    http://onlinelibrary.wiley.com/doi/10.1111/ijn.12320/abstract

  • eallen Elizabeth Allen - Regional Faculty Lead 20 Nov 2014

    Hi Amelie

    I am wondering whether it would be better to group the tools that appear in the RHS list according to topic rather than alphabetical?

    Someone recently asked for a monitoring report template and I couldn't see one there but not sure if I missed it?

    Best wishes

    Liz

  • jobygeorge05 Joby George 6 Oct 2014

    Many thanks and wonderful to hear that,Hope we could have a great interactive session soon.Regards,
    Joby George

  • GHN_Editors The Editorial Team 6 Oct 2014

    Great - thanks for your feedback, this is very helpful.
    I'd like to point you in direction of one of our partner groups, the EQUATOR Network, who have lots of different free guidance articles and guides for reporting on health research (http://www.equator-network.org/).
    However, you're absolutely right that this is a great talking point, and I will discuss with the EQUATOR network about whether they might like to run an 'ask the expert' month on this topic, and we can all share our questions and experience.
    Thank you!
    the Editorial Team

  • jobygeorge05 Joby George 4 Oct 2014

    Great,I would like to mention that it would be good if we could frame a document over how to write a article or a manuscript.I think most of the budding nurses/health care professionals are not aware of what,How to write about an article.I think we all can develop a one.
    Many thanks for the opportunity.
    Regards,

    Joby George.RN,India

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