Having a TMF entirely on paper, stored in filing cabinets (even the fancy compactors), is now thought to be unsustainable. Many companies are now in the process of transitioning to eTMF’s, resulting in a hybrid of paper and shared file drives, which are also...
A Trial Master File (TMF) is the collection of documentation that allows the conduct of the clinical trial, verification of the integrity of the trial data and demonstrates compliance of the trial with Good Clinical Practice (GCP). Today, clinical trials take place at...
India, with its large disease burden and experienced medical professionals, has been actively contributing to the global drug development, for more than a decade. However, the recent changes to regulations, although intended to safeguard patient rights and ethics, has...
The deadline for industry comment on the EMA draft reflection paper on GCP compliance in relation to trial master files (paper and/or electronic) (TMF) for management, audit and inspection of clinical trials was 30 April 2013. The draft paper included several recent...
As I start to write this blog I have to admit this is not a topic in which I consider myself an expert. I think more of as a pessimist actually. I have never had a negative experience with a Monitor as a translator during an audit BUT nevertheless, I take a few...
The 30th Annual Meeting and 4th Global QA Conference will be held Tuesday – Thursday, 8th - 10th of April 2014. Three days of plenary and concurrent sessions will explore hot topics and the latest regulatory interpretations in the field. Sessions will focus on...
I manage a small group of people. I engage with colleagues. I audit investigator sites around the globe. I have worked for small companies and huge companies. I have red hair. I have a few soap boxes (for those of you not familiar with the concept of a “soapbox”,...
Within research, for a Quality department to be effective, it is essential that they retain independence from those within the Clinical organisation. This reduces any influence from the Clinical group on the work of the Quality department. However, it is also...
We would like to take this opportunity to wish our readers, clients and partners continued success going forward into 2014. We are grateful to you as the figures regarding the readership of the blog continue to climb steadily. Follow us on our social media streams or...
Source data is being collected utilizing electronic methods. This is seen at a site (for example via electronic medical records) but also subjects are being asked to provide data electronically. This could include an interactive voice/web response system or even...
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