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.
On 12th and 13th September a group of 11 GCP-RMA members got together in Sandwich, UK for our autumn members’ meeting. Representing a range of companies from large multinational pharmaceutical companies to CROs and specialist consultants, we covered a number of different topics. A highlight worthy of mention was a presentation from Robert Sharpe (Tessella) on the topic of digital preservation. After clearly explaining the potential difficulties in managing electronic records for lengthy periods of time, he outlined an initiative underway amongst pharmaceutical companies to characterise – and so help preserve – digital file formats that are “peculiar” to our industry.
In contrast – and recognising that a significant propertion of our archives are still paper – we had a great presentation on the implementation of a physical archive tracking system. Managing paper records aso comes with its issues and the presentation highlighted how the selection and implementation of new tracking software helped to improve processes.
This was followed by an overview of a corporate program to introduce replace a legacy electronic trial master file system with a new process-driven system and supporting processes. One of the key challenges of the project was in tackling the huge volume of legacy data and so the presenter outlined the strategy that was being adopted to ensure the migrated data was fit for purpose.
The remainder of the agenda covered topics such the impact of recent changes to pharmacovigilance regulations, the development of electronic investigator site files (eISFs), the destruction of original hard-copy documents and the use of electronic and digital signatures. A working party has just been established within GCP-RMA to develop a set of FAQs on electronic signatures which will eventually be published on this website. Everyone agreed that the meeting was an overwhelming success. We’re all now looking forward to the next meeting in Spring 2013!
The GCP-RMA held a very successful members meeting last week, kindly hosted by Pfizer at their Sandwich UK site. As usual, the agenda covered a wide range of topics including hard-copy archive tracking systems, updates to the pharmacovigilance regulations, electronic signatures, document destruction policies, and electronic investigator site files (eISFs). Perhaps the highlight of the meeting – apart from the valuable networking sessions – was a superb presentation and subsequent discussion on Tessella’s digital preservation project for the pharmaceutical industry. Dr. Robert Sharpe gave a very thorough overview of the issues related to digital preservation and introduced the project to try to solve some of the problems that are facing our industry in this area.
GCP-RMA schedule two meetings each year which are free to attend for members.
The GCP-RMA Executive Committee are busy developing the agenda for the 2012 Autumn Members’ Meeting. This meeting will be hosted by Pfizer on Wednesday 12th September and Thursday 13th September. It is early days at the moment but the agenda is likely to include:
- DIA Destruction Framework
- Case Study – Archive Tracking System
- EMA position on eTMFs
- Pharmacovigilance Records Management
- Digital Preservation – with special guest Robert Sharpe
Accommodation has been booked for attendees at The Abode, Canterbury.
For more information about this meeting, please contact a member of the Executive Committee.
Increasingly, third party storage vendors are being used to store documents on behalf of pharmaceutical and biotechnology companies, clinical investigator sites, contract research organisations and laboratories. However, the document owners are ultimately responsible for the safety and security of those records until they may be destroyed. It is critical therefore that a vendor is chosen that is appropriate for the task. The GCP-RMA have developed a set of guidelines to assist in the selection of such a supplier. The guideline is FREE to download HERE and from our Publications web page.
The GCP Records Managers Association (GCP-RMA) is holding its Spring meeting on 14th and 15th March in Weesp, Netherlands. The theme of the meeting will be “Challenges and Opportunities of e-Records Management” and the agenda is looking great. Includes:
- Quality checks on trial master files: sponsor perspective; CRO perspective; and report back from DIA QC special interest group
- Long-term digital preservation: introduction to OAIS; EDC data and TMF
- Going paperless
- From document management to content management
- Technology interoperability
- TMF migration strategies
- Special topics of interest, including: paper destruction; eTMF case study; commercial archive vendors
As usual, there is no charge for attendance at this meeting but attendance is limited to GCP-RMA members only. See our website for membership details, including membership criteria.
The next meeting for GCP-RMA members will be held on 20th and 21st September in Nottingham, UK. Once again, this promises to be an agenda-packed meeting with a wide variety of interesting topics. The agenda has not quite been finalised but currently includes:
- management of pharmacovigilance (PV) records; what is the impact for management of clinical trial master files?
- destruction of original trial documents – what guidance does the DIA TMF Reference Model SIAC have?
- centralised versus decentralised management of sponsor trial records; which approach is best suited to your circumstances?
- third-party document storage vendor selection – a checklist
- third-party document storage vendor selection – what should be in your contract?
- archive tracking systems – a case study
- electronic trial master files (eTMF) – a case study
- member feedback/discussion
- member annual general meeting
This conference is free to attend for GCP-RMA members.