Category Archives: e-records

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

eTMF Vendors – Who Has the Largest Market Share?

Posted on November 20, 2011 by

This is a question just sent through to us….. which vendor has the largest market share of the eTMF solution vendors? I guess the answer will depend on whether we’re talking about most client licenses/seats or highest volume of sales and whether … Continue reading →

Posted in e-records, TMF | 2 Comments

eTMFs from your Contract Research Organization (CRO)

Posted on July 19, 2011 by

I was recently asked what happens at the end of a clinical project when the CRO managing the study wants to hand over an electronic trial master file (eTMF). The sponsor may not have an existing eTMF to take the … Continue reading →

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

PDF/A Standard Now Uses PDF v1.7

Posted on July 6, 2011 by

The International Organisation for Standardisation has just released the second part of its standard for long-term digital preservation of documents, ISO 19005-2:2011. The first part of the standard (ISO 19005-1) was issued in 2005 and describes the file format PDF/A … Continue reading →

Posted in Document Storage, e-records, Technology | 2 Comments

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 →

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

What solution for my eTMF?

Posted on June 14, 2011 by

We often get asked what technology solutions are available for the management of electronic trial master file content. There are countless companies that provide bespoke IT development services to build your own system, often based around Sharepoint or Documentum. However, … Continue reading →

Posted in e-records, TMF | 1 Comment

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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NIST Releases New Draft Cloud Computing Synopsis

Posted on May 18, 2011 by

The National Institute of Standards and Technology (NIST) has released a very interesting (but long!) document (click HERE to download) that explains cloud computing technology in plain terminology. At 84 pages and 1.9Mb, it is not a brief document but … 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