Home >> Beyond COVID-19: A solution-focussed forum >> General Discussion >> GCP essential document retention
- This topic has 3 replies, 3 voices, and was last updated 3 days, 2 hours ago by
Cindycolin987.
-
AuthorPosts
-
-
July 2, 2020 at 5:30 pm #7723
LRobison
ParticipantHello all,
I’m interested to hear what processes you recommend for archiving electronic GCP essential documents to ensure they are accessable for audit in years to come. For clinical trials we may not be able to access Word documents over a period of time if there are significant software upgrades. Do all files need to be converted to a PDF/A? (This could be a big job!).
Many thanks.
Laura
-
July 8, 2020 at 5:51 pm #7758
praxisaus
ModeratorHi 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. 🙂
Melanie
-
July 23, 2020 at 12:20 pm #7802
LRobison
ParticipantThanks Melanie!
-
January 25, 2021 at 9:16 pm #9365
Cindycolin987
Participant<span data-sheets-value=”{"1":2,"2":"Google are going together better at rating sites that meet their guidelines for ‘quality’ and ‘user satisfaction’ here – I am putting such things in quotes here to highlight the slightly Orwellian doublespeak we have to work with. Learn how to index your website on google"}” data-sheets-userformat=”{"2":513,"3":{"1":0},"12":0}”>Google are going together better at rating sites that meet their guidelines for ‘quality’ and ‘user satisfaction’ here – I am putting such things in quotes here to highlight the slightly Orwellian doublespeak we have to work with. Learn how to index your website on google</span>
-
-
AuthorPosts
- You must be logged in to reply to this topic.