Jun 272012

Electronic Document and Records Management systems (EDRMS) have the potential to answer the needs of some Research Data Management scenarios.

EDRMS offer file sharing, file versioning, flexible access control, and retention, preservation and discovery services (albeit most often in a closed environment). In the case where a project’s data is bound up in everyday office formats, and does not need a database or other structured format, an EDRMS can be used to bring rigour and robustness to otherwise freeform file management. Although there will often be a reluctance on the part of  a researcher to ‘get organised’, there are often circumstances where there is no choice: the nature of the work means that a high standard of file management is more than a matter of efficiency or professionalism and it becomes a requirement of the funding body, subject to audit. This is the case, for example, with all clinical trials.

In workpackage WP3 we are looking to improve project management practice in general and promote more robust RDM of unstructured data by developing a standard ‘file plan’ for use in research. This will be backed up by policy changes which will encourage, (then in the fullness of time mandate) the deposit of project documentation in our EDRMS. The file plan must be generic enough to be useful for researchers who just need to improve their document organisation, whilst also allowing for the more robust requirements of those needing to comply with external oversight. The starting point which informed this work was the JISC advice on Developing a File Plan in the JISC Business Classification Scheme (BCS) and Records Retention Schedule (RRS) for Higher Education Institutions infokit.

We are working with the Centre for Lifespan and Chronic Illness Research (CLiCIR) to develop an electronic Trial Master File (eTMF) for use in clinical trials. A Trial Master File contains essential documents: every document that is used to conduct and report on a clinical trial. Our eTMF will complement the locked filing cabinet which is currently used to satisfy the demands of audit. The Medicines and Healthcare products Regulatory Agency (MHRA), which is responsible for the regulation of medicines, requires each trial to be conducted in accordance with a Standard Operating Procedure (SOP).  The MHRA carries out unannounced inspections to audit SOP compliance including data management arrangements and storage procedures. We hope to demonstrate that an eTMF could be more efficient and at least as robust as the current paper based arrangements. In doing so, we are also developing our general purpose file plan.

We think the EDRMS will offer considerable benefit in respect of  managing the large volume of documents and data produced in drug trials, whilst addressing the legal requirements on data retention and security. In addition, we expect it to make the sharing of data between chief investigator, co-ordinating centre and participating sites more effective.

The workpackage mini-plan is as follows:

  1. Develop the File Plan
    • Define folder structure
    • Define classification, retention and disposal requirements
  2. Define Meta data requirements
  3. Build a Model Office
  4. Draw the life cycle of a clinical research project
  5. Develop roles, responsibilities and access
    • Define roles and access level (including: ownership, managed by, administrated by, visible to …)
    • Set security and access
  6. Create Data Management and Maintenance Policy
    • Develop guidelines for data maintenance and update
    • Develop guidelines on retention
  7. System Implementation
  8. Train users

After close consultation with our CLiCIR  colleagues we have produced a draft folder structure which is ready to deploy to support the eTMF and to take to other research groups for comment.  It includes many folders which are generally applicable and some which are peculiar to health related research. It also highlights those folders which must be highly secure in the context of the eTMF.

Each item in the EDRMS has associated metadata. In addition to the basic file management metadata required by the system, it is possible to add additional fields for project specific data. The work so far has focused on the metadata needed to describe a research project at UH.We will consider how this maps to other schema, such as those used by our CRIS, our  Research Archive and the various minimum metadata sets circulating in JISCMRD, in due course.

The EDRMS can be used as primary store of actual data but also as a management tool for externally located data, be it electronic or hard copy. It can manage the retention and disposal of both. The various requirements for retention and disposal of different types of research data have been brought together in a draft retention policy. (It is interesting to note that although the EDRMS is in theory designed to deal with the time scales involved, most of the retention schedules we see extend beyond the expected lifetime of the EDRMS itself.)