How Much Do YOU Know About eTMFs?

We have been maintaining Trial Master Files for many years with increasing levels of consistency and quality since the introduction of Good Clinical Practice guidelines in the 1990’s and more latterly, the publication of European Directives and Regulations that make compliance a legal obligation. However, a quick review of published agency inspection findings shows that industry and clinical sites are still making many mistakes when it comes to document management. So do we really understand what the regulatory requirements and, importantly, how to comply with them in an efficient and cost effective way? Add to this the advent of technological solutions that now make it possible to manage our TMF content electronically, and we have a whole realm of other challenges to face.

For example, do you understand:

  • what type of file structure the regulatory agencies may expect to find when they inspect your trial master file?
  • what the indexing requirements are for the trial master file?
  • what records related to third parties you are expected to maintain when you outsource trial activities?
  • how you file emails, email conversation threads and email attachments?
  • where you file documents such as the DSUR which may appear in several places (Ethics, Regulatory, Safety)?
  • what the validation expectations are for an electronic trial master file (eTMF)?
  • whether electronic signatures are permitted and if so, how they should be implemented?
  • whether it is allowed to destroy paper original documents after they have been scanned into an eTMF?
  • how you can provide the site with an electronic investigator site file (eISF) and what regulations you need to follow?

These questions – and many more – will be answered at a one-day workshop dedicated entirely to the subject of trial master files and electronic trial master files. The workshop is being run on Wednesday 28th November in Munich immediately prior to the 13th DIA Electronic Document Management Conference. Your workshop presenters are Eldin Rammell, Managing Director, Rammell Consulting Ltd and Karen Redding, Business Development Director, Phlexglobal Ltd. The workshop content has recently been re-written to include latest industry and agency experiences, more focus on electronic signatures and eTMF implementation challenges. This content-packed workshop is great value as a stand-alone training event at €550 (approx. £440) but can also be taken as an optional extra to the DIA EDM Conference. The workshop fee is fixed but if you also plan to attend the conference please note that the closing date for the conference early-bird discount is approaching fast. This workshop held in previous years has been fully booked!



About rammellel

Records management consultant to the life sciences / pharmaceutical industry
This entry was posted in e-records, Regulations, TMF and tagged , , , . Bookmark the permalink.

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