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Hi all :),
Would you please advise on some questionable issues related to TMF RM filing.
The issues are the following:
1) Site-specific correspondence (emails) regarding safety issues (SAE, CIOMS, etc.). Which artifact it should go to? I am choosing between the following artifacts: 05.04.09 Notification to Investigators of Safety Information, 05.05.01 Relevant Communications, 07.03.01 Relevant Communications.
2) In TMF RM there are the following artifacts: 04.03.01 Notification to IRB or IEC of Safety Information, 03.03.01 Notification of Safety or Trial Information. We always filed there Notifications + AoRs of safety information. The issue is that for some countries the process is different and instead of notification they submit application and receives approvals. There can be also additional documentation regarding safety: Requests, Responses, Confirmations, etc. Should all these documents go to 04.03.01 and 03.03.01? Please confirm.
3) In case a notification to RA/EC includes safety and non-safety information (for instance, SUSARs + Protocol _ICFs, etc.) which artifact such documents should go to?
4) Artifacts 03.03.03 Regulatory Notification of Trial Termination and 04.03.03 IRB or IEC Notification of Trial Termination. We place there not only notifications/AoRs but all types of correspondence (applications, approvals, responses, etc.), as in some countries the process is different and they do not notify the authorities but submit an application for approval instead of notification. Please confirm if our approach is correct.
Thank you very much,
Best regards,
Maria Pedko | Document Manager | PSI CRO
maria.pedko@psi-cro.com
http://www.psi-cro.com -
Hi Maria,
1. All safety related email communications should be filed to Zone 07 Artifact 07.03.01.
2. Yes, all safety notifications to IRB or IEC and Regulatory are required to be file under 04.03.01 and 03.03.01 respectively.
3. Documents which needs review and approval from RA and EC should be filed under Submission classification. Even other essential notifications rather than safety also need to be filed under Submission.
4. Notification of trial termination artifact should include only end of trial notification correspondence and related documents. Other documents related to other event required to classified as per content.
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