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I commonly see audit reports filed in the Company’s internal quality system. You can specify the filing location on the Study TMF Plan/EDL rather than generating a NTF.
Best regards,
Allison Grosik
LMK Clinical Research ConsultingHi Sarah,
From my experience, I have seen both scenarios for filenotes. More commonly I see the NTFs processed to the artifact of the corresponding document. This helps ensure the document is not lost in the ‘catch all’ Filenote artifact.
Be sure to capture the company’s decision on the study TMF index.Best regards,
Allison Grosik
LMK Clinical Research ConsultingI have not seen Sponsors require other company names or study titles to be redacted from site personnel CVs. In my opinion, if the CV includes study information that is already present on Clinicaltrials.gov, it should not be an issue. I agree with Eldin to check the CDA for specific language.
Best regards,
Allison Grosik
LMK Clinical Research ConsultingHi Dee,
From my experience, Health Authority submission documents generated by the CRO (e.g. CTAs, substantial amendment notification forms, cover letters, etc)
are filed in the study eTMF. CROs usually do not have access to file directly into the Sponsor regulatory system.I have seen Sponsors file regulatory documents directly in their internal system for only those countries where they hold submission responsibility. This is common for USA FDA.
Best regards,
Allison Grosik
LMK Clinical Research ConsultingJanna- I agree with filing the ‘Site Activation Checklist’ to 05.02.17 IP Site Documentation.
In regards to your filing question on the ‘Certification of Clinical Study’, it sounds to me to be either an Ethics Committee or Regulatory Authority Approval. I recommend filing either to 04.01.02 IRB/IEC Approval or 03.01.02 Regulatory Authority Decision dependent on the approval body.Best regards,
Allison Grosik
LMK Clinical Research Consulting