Replies to post #598030 on NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

I also believe and have heard via my friend in my NWBO group (as Thermo said) they are very close to being accepted by the MHRA. So really weeks not months let alone years. Now after MHRA has accepted the application, the Trial Master File is not THAT far off...

The trial master file issue is humorous, Here is what EMA says about the TMF

2. Introduction
A TMF is the collection of essential documents that facilitates the conduct and management of the clinical trial and allows that the integrity of the trial data and the compliance of the trial with GCP can be evaluated. The Regulation does not differentiate between paper and electronic TMFs therefore all basic requirements are the same for both formats. The need for a TMF is set down in Article 57 of the Regulation. The TMF is used by sponsors and investigators for the management of the trial and by auditors, monitors and inspectors to assess whether the sponsor and the investigator(s) have complied with the Regulation, the principles and guidelines of GCP and with other applicable regulatory requirements. Article 57 states “the clinical trial master file shall at all times contain the essential documents relating to that clinical trial.” The requirement “at all times” means that the TMF should be updated, and completed in a timely manner. Article 58 of the Regulation also requires that “any alteration of the content of the trial master file shall be traceable”. The TMF should provide for document identification, version history, search, and retrieval, also, as stated in Articles 57 (and 58) “it shall be readily available, and directly accessible upon request, to the (competent authorities of the) Member States”. The same requirements for access to the TMF should be in place for the monitors, auditors and ethics committees.

In short, the TMF is soemthign that is always current. Not something one spends years on completing after the trial is over.