Banning email used in Clinical Research

Many of us will struggle to remember the days before email. Remote communications were typically restricted to phone calls, faxes and letters.

Today – an email can be drafted and sent in seconds. Many of us will have sent email messages containing content that we might not necessarily say to a persons face.

But what about Clinical Research. Why in particular does the use of email in Clinical Research cause an issue?

During our many years of implementing EDC – Electronic Data Capture – we have come across many requests to limit the use of communication capabilities within the software. As developers, in our naive world – we felt that better means of communication would be accepted as better. In reality, sponsor companies were nervous of the idea of information being communicated in a way that was considered inappropriate –

What if the site communicated clinical data in an electronic post it note?

Often – the definition of ‘inappropriate’ was that the information was electronically held on record – and therefore considered part of an auditable file. Instead, correspondence was to be carried out by other means – paper, or email – often a non audible, or, easily hidden form.

We have struggled with this. The fact that an auditor cannot find a communication does not mean that the communication did not occur, just that the auditor cannot prove it.  Is the use of alternative methods of communicating between the sponsor and a site not equivalent to a rogue car dealership avoiding the tax man by having 2 sets of accounts – the official… and the under-the-counter unofficial accounts. Is the choice of using not auditable means of communication not tantamount to covering up the facts.

The second challenge we see with the use of email in a clinical trials setting is the fact that the act of sending an email can create the assumption of the addressee both receiving, and often actioning it. For instance, if a monitor sends an email to an investigator does it mean that the investigator has a). read it and b). taken action as a result of it? Not necessarily. Can the Monitor ‘see’ if this has happened? No.

This particular challenge area is something we have wanted to address in Clinpal. We believe that it is possible to safely reap the benefits of modern electronic communication to speed up the process of capturing and cleaning clinical trial data.

Lets look at how Clinpal handles messaging.

When a message is sent – either the message is informational – requiring no action – or, is actionable. Lets look at a particular example.

An Investigator receives a message based on rules defined for the study that a patient has not recorded a blood glucose measurement as the protocol schedule defined. The system automatically raised this as a message, but associated the message with the task that the recipient (the investigator) might perform.


Message with associated action

This message automatically has 2 associated actions – to create a pre-specified task – send a message to the relevant patient – therefore reducing the need to create a new task, and associate that task to the patient..  the second available action is to allow the recipient to create their own task.

With this kind of approach,  the level of training required is reduced – the actions are available instead of have to be found – and the task that has to be performed is queued to the appropriate user until they have carried out appropriate actions.

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