Category Archives: e-records

MHRA Draft Guidance on GxP Data Integrity….. a Few Thoughts

In July 2016 the Medicines and Healthcare products Regulatory Agency (MHRA) released a definitions and guidance document on the topic of data integrity for GxP regulatory data. The public consultation period closed on 31 October 2016. However, I’ve been hearing … Continue reading

Posted in Compliance, e-records, Technology | Leave a comment

Training Course: Managing Electronic Records

This is a just a quick promo for a one-day training course that I am running with my colleague, Russell Joyce, on behalf of the Scientific Archivists Group. The course is aimed at anyone with responsibility for electronic records….. for … Continue reading

Posted in e-records, Training | Leave a comment

MHRA Comments on Records Retention

It seems that the latest submission from the MHRA on their GCP Forum has provoked a great amount of discussion and raised concerns amongst industry. What is it all about? Well the MHRA have provided some clarification on the topic … Continue reading

Posted in e-records, Records management practice, Regulations, TMF | 1 Comment

Is the Clinical Database part of the Trial Master File (TMF)?

This was a question posed recently on the MHRA GCP Forum (see http://forums.mhra.gov.uk/showthread.php?1858-Database-and-TMF).  I posted a response (though it wasn’t published by the Forum Moderator) pointing out that for several reasons the clinical database should not be considered an “essential document” … Continue reading

Posted in Compliance, e-records, Technology, TMF | 2 Comments

Now is the Time for the Electronic Investigator Site File (eISF)

The latest issue of Applied Clinical Trials included an article with some interesting statistics regarding clinical trial sites (see ‘Characterizing the Real Cost of Site Regulatory Compliance’ by Kenneth A. Getz). The statistics quoted come from a survey conducted at the … Continue reading

Posted in e-records, Technology, TMF | Leave a comment

How to Implement a Successful eTMF Project

If you are considering implementing an eTMF or perhaps you are already in the middle of such a project, there is still time to register on our 1-day eTMF workshop being held on Monday 1st December in Berlin, Germany. Technology solutions … Continue reading

Posted in e-records, TMF, Training | Leave a comment

The Multimedia TMF Becomes a Reality

The clinical records management community is currently enjoying an interesting debate regarding the need for interoperability standards for electronic trial master file (eTMF) content. The need for organizations to efficiently exchange documents and metadata between systems is becoming increasingly critical, … Continue reading

Posted in Document Storage, e-records, Regulations, TMF | Leave a comment