February 8, 2022 at 5:06 pm #4378Ellin LiParticipant
I am new to TMFs so please be patient with me. I am managing/organizing the documents for an ongoing TMF. The company can only do paper TMFs but have various relevant communications via email. Should I be printing out every relevant email communication? Or can I keep the emails digitally filed?
February 8, 2022 at 5:29 pm #4383Eldin RammellParticipant
Even in the absence of an electronic TMF I would advise looking at solutions that enable you to retain the emails digitally. You need to ensure you are meeting the relevant regulatory guidance for managing documents electronically but these are not particularly arduous. An option might be to manage emails within your email system while the trial is ongoing – BUT ensuring you have appropriate processes to ensure they are actually managed and not just dumped into folders! – and then exported at the end of the trial and saved to a suitable repository e.g. read-only, access-controlled and designated area of a network storage device.
A critical benefit that you achieve by retaining digitally is the ability to search through the content. This could be invaluable in the event of an inspection.
Whatever you come up with as a solution, make sure it is properly documented and any tech qualified for use.
February 9, 2022 at 6:31 pm #4392Jason King-AndreiniParticipant
New or experienced, this would be a questions any TMF professional might have as they initially address a new project.
I support Eldin’s earlier response, where and how you can minimize your risk and maximize your efficiencies, it is important to do so – and digital solutions can help you do this. However, if you are embracing new or unique tactics, think about what you and your company must have to support those changes.
1. If you go with a digital solution, you need to assure it meets 21 CFR Part 11 requirements, or specific regulatory requirements of the jurisdiction in which you operate.
2. If you convert to a hybrid eTMF/pTMF model, you should modify your TMF Plan to note these changes, and also manage the record of source system on your specifications/index for your TMF.
To your first question, which I don’t think it was directly addressed, if you do not have language in processes or plans to support digital filing, then yes, you will need to print out each email (with attachments) to file in the paper TMF, which should be in keeping with your TMF Plan – always confirm against that document.
In essence, you can manage your TMFs in just about any which way but loose, but you must be certain that your firm’s SOP and/or Plan language supports the methods employed. If it doesn’t yet, but your team is amenable to alternative methods – change your plan first, and then use the new process.
I hope this helps.
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