It seems that a high proportion of people who are engaged in some aspect of GCP document management – either as creators, owners, reviewers, records managers – have several unanswered questions about electronic signatures. For example, what exactly is an electronic signature; is that the same as a digital signature? Are they accepted by the regulatory agencies or are they even legally acceptable? How can electronic signatures be used with TMF documents?
The MHRA have recently added some guidance in this area in their GCP Guide (the “Grey Guide”). In addition, Wingspan have recently published a White Paper on the topic of signatures in clinical trials. To provide further support to the GCP community, GCP-RMA have just initiated a project to provide a Frequently Asked Questions resource on the topic of electronic signatures.
The work group have already identified a set of 21 questions that it considers are representative of the primary questions that industry colleagues are commonly asking in this area. The questions have been tagged as being Technical, Regulatory/Legal, Process or Retention focussed and each category is being tackled by the work group across the next 4 months. So, do look out for the appearance of this resource on our website. It has not yet been decided whether the FAQs will be released in groups or whether we will wait until completion of the project. The FAQs will also be available in PDF format for easy download and use within your organization.
