Category Archives: Records management practice

Is it OK to “manipulate” PDFs to improve records management?

Posted on January 23, 2012 by

This is a question that I hear posed fairly frequently, I guess as a result of organisations managing electronic records rather than – or in addition to – traditional paper records. A typical scenario is an electronic document received into the … Continue reading →

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

Are Copies as Acceptable as Original Documents?

Posted on November 25, 2011 by

This is a question that I seem to be hearing with increasing frequency! I think the reason for this is that an increasing number of companies and organizations are introducing electronic document management systems (EDMS). Where there are hard-copy records … Continue reading →

Posted in Compliance, e-records, Litigation, Records management practice, TMF | 2 Comments

Documentation Risk Adaptations in Clinical Trials

Posted on October 30, 2011 by

A paper has recently been published under the joint auspices of the UK Department of Health (DH), the Medicines and Healthcare products Regulatory Agency (MHRA) and Medical Research Council (MRC) describing risk-adapted approaches to the management of clinical trials of … Continue reading →

Posted in Compliance, Records management practice, Regulations, TMF | Leave a comment

Why Good Records Management Is Key

Posted on October 5, 2011 by

Authors: Eldin Rammell & Karen Redding (Phlexglobal Ltd) The past year has seen significant consolidation of mid-size CROs, with many of them being bought or put up for sale. In particular, the top six or seven CROs seem to be … Continue reading →

Posted in Records management practice, Technology, TMF | 1 Comment

Questions a Sponsor Should Ask a CRO

Posted on July 27, 2011 by

While I was browsing through my website analytics, I came across the above question that was entered into a search engine which in turn directed somebody to the website. It got me thinking what a great question it was! So, from … Continue reading →

Posted in Compliance, Records management practice | Leave a comment

Are You Drowning in Email?

Posted on June 30, 2011 by

Whenever I chat with business colleagues, one of the most common issues that gets raised is that of email management: we’re receiving too much and spend too much time responding. Well, I just came across an “Email Charter” and thought … Continue reading →

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Guidelines for GP Electronic Patient Records

Posted on June 1, 2011 by

The Department of Health have recently (21 March 2011) revised their good practice guidelines for GP electronic patient records. I’ve just been browsing through the document and whilst much of the content is not directly applicable to me, I was … Continue reading →

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Retention schedules – Finding your way through the maze

Posted on May 9, 2011 by

The development and use of records retention schedules is fundamental to good records management practice. However, it is a topic that is often misunderstood and one that frequently poses a challenge to records managers and archivists. The records manager has … Continue reading →

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Use of the DIA TMF Reference Model by CROs

Posted on May 7, 2011 by

Here’s a quick plug for a great article about the use of the DIA TMF Reference Model by CROs. The Reference Model is a standardized model for the structure and content of the essential documents that comprise the trial master … Continue reading →

Posted in e-records, Records management practice, TMF | Leave a comment