praxisaus

Forum Replies Created

Viewing 5 posts - 1 through 5 (of 5 total)
  • Author
    Posts
  • in reply to: GCP essential document retention #7758
    praxisaus
    Moderator

    Hi Laura. Good question!

    The EMA has some excellent guidance on this – and its best to archive in PDF (sorry). Its about ensuring integrity of data and data change history records.

    This link might be useful – refer to sections 5 and 6 in particular. The TGA adopts many of the EMA guidance – this is not one on their excluded list, so its safe to say if you follow this guidance you would be compliant with regulatory requirements.

    I would also always recommend you speak to the Sponsor and seek their advice too. 🙂

    https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-content-management-archiving-clinical-trial-master-file-paper/electronic_en.pdf

    Melanie

    in reply to: What is the new normal? What have we learned? #7296
    praxisaus
    Moderator

    Good question Aaron, and as always, the elephant in the room. The efforts of the national joint working parties  have made these issues a priority but consensus between and also within jurisdictions remains a sticking point. What we did see is HRECs within states pooling resources to respond to the pandemic to ensure rapid review processes and better allocation of resources, in ways they hadn’t done previously. Will this be the new norm moving forward?  The next hurdle: how can we apply this collaborative approach to Governance review? This is a question for the CTPRG (which is no doubt already on their agenda pre Covid)….

    in reply to: What is the new normal? What have we learned? #7272
    praxisaus
    Moderator

    We have learned that we can adopt and adapt and that we can do that rapidly. That barriers we imagined as too challenging aren’t really insurmountable . Now the challenge is to maintain that momentum. To return to our state of status quo is a risk to our longer term competitiveness as we know a that all regions have also had to adopt and adapt. Our window of opportunity is now.

    in reply to: Consumers in COVID-19 research #7266
    praxisaus
    Moderator

    Hi Aaron. Its certainly been reported in the UK as you mention. In Australia what we have heard is that consumer co-design has dropped significantly initially but our consumer representatives from across various disease groups are saying that enquiries for involvement are now flowing through – and the inclusion of consumers in national forums is growing rapidly.

    in reply to: External Access to Monitors #7026
    praxisaus
    Moderator

    Hi AMaRC. Unfortunately, in the circumstance you have described , if the Sponsor is not prepared to review the data despite your attempts to permit access, you are stuck.
    Have you had a conversation to discuss why this is not possible?
    What is the risk they are trying to manage internally?
    Do you have institutional permission to share these records? If yes, have you supplied the sponsor with evidence of this permission?
    I would suggest first making sure you fully understand what the barriers are and then try to address them with documented evidence of levels of permission. Good luck.

Viewing 5 posts - 1 through 5 (of 5 total)

Disclaimer

The comments and resources posted here have been provided by members of Beyond COVID-19: A solution-focussed forum (‘Forum’) and other sources. They are offered for your reference only and are not intended to represent the best or only approach to any particular issue.

The Beyond COVID-19: A solution-focussed forum has not attempted to evaluate any posted material.

Neither ACTA, as host of the Forum, nor the individuals or collaborators on this Forum, make any guarantee with regard to the accuracy, completeness or suitability of any advice or resource, and they assume no responsibility or liability in connection with the use or misuse of any material.

The comments and resources posted here should not be construed as clinical or legal advice, and users should seek appropriate advice to address specific facts and circumstances.

Copyright in posted materials belongs to the respective owners, whether or not a copyright notice appears on the screen displaying the materials.