According to ICH-GCP, the ‘Financial Aspects of the trial’ (i.e. financial agreements with sites) and ‘Signed Agreements between involved parties’ are part of the essential documents. In our company the agreements between sponsor & the manufacturing vendor are described in Quality Agreements & Technical Agreements. I understand these are therefore required according to ICH-GCP. Financial agreements are kept separately in a SOW. If an agreement is only capturing the financial aspects with a vendor – are they then also considered as required for TMF? Or only considered as supporting documents? And should these supporting documents then also be kept in a validated environment?
Thank you for your feedback,