A new TMF guideline on GCP compliance in relation to TMFs was recently published by the European Medicines Agency (EMA). The guideline incorporates previous guidance in the EMA draft reflection paper on TMFs and includes guidance based on industry experience, and in addition further guidance from the latest ICH E6 revision.
This is still a draft for consultation, offering useful additional direction on important topics within the TMF/eTMF industry such as the management of numerous electronic systems and the destruction of original paper documents after digitization.
The draft guideline can be downloaded from the EMA website:
By Gillian Gittens, Phlexglobal
What our customers say about us...
Senior Director in Clinical Operations, top 20 global pharma
Associate Director of MRP Management, US pharma