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Hi Ellin,
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.
Best,
JasonHi Shah,
If the site was initiated and especially if it has IP on site – requires formal closeout as well. If no screens and screening is closed, send in a CRA to closeout the site.
Best,
JasonHello Amrita,
Regulatory 03 is the Import/Export License application and license itself. It can include attachments which may be duplicated elsewhere in your eTMF (i.e., QP Certification, Country Specific Site Lists, etc.) however, they are fit for purpose to accompany the applications and therefore, are not duplicates – but should be attached with the application if provided.
IP Regulatory Release Documentation 06 and IP Site Release Documentation 05 are the two which I can easily find confusing. The IP Regulatory Release in 06 is all the supporting documentation your CMC Reg utilized to confirm that all the needed documents to release an IP to a country and overall for the trial is in hand (in the eTMF) – these items also, may appear elsewhere as standalone documents. I would check with your CMC Reg contributor or CRO (same function) to confirm what the release process is and how it is governed at your organization. The information they site as being confirmed to provide IP to the trial – that is what should be filed in 06 IP Regulatory Release. The 05 IP Site Release is similar, however, it is site specific and usually is comprised of a checklist (formal output from an SOP) which confirms that the sponsor has all the documents required from the site to release IP to the site. (ALERT: “…the sponsor has….” does not include – IN THE eTMF! Just because someone at your company saw the 1572, the FDF, the IDS pharmacy review, etc. doesn’t mean it has been filed. It is possibly an advantageous milestone to share that you can’t file the IP Reg Release until all the associated documentation is filed into your eTMF.
I hope that helps. Best practice to discuss amongst your teams and apply your philosophy to all the trials you are performing. Document, as you progress, specific docs you receive in this section from your contributing team and challenge when different study teams submit different materials to achieve the same objective – this could be an opportunity to harmonize your business practices.
Best,
JasonHi Maria, I would encourage you and your team not to look at the TMF RM so much as a rule book, but a personalized guide, and your organization’s agreed and documented interpretation of each of the classifications will be important. There should be a study specific version of the reference model sharing your organization’s placement – and most CROs are very open to helping and negotiating the tool with you for the study. It can be an investment – but speaking to the CRO gains insights like their SOP impact on where something ought to be filed and how best to file it. The Suitability of Facility document you are referencing – does, in my opinion and with no experience of your organization’s practice – seem an option for the location of the document. However, there is normally a suitability statement as part of the Pre Trial Monitoring evaluation report. Just some thoughts.
THanks,
Jason