Sudhir Patel, Chief Operation and Co-founder, Quinary Clinical Research, in this white paper, discusses the concepts and methods to achieve a paperless Ethics Committee submission by automating and eliminating paper forms as well as applications from the processes that currently require such documents to be completed
An Article published in June 30, 1975 clearly described “The Office of the Future” which touted the concept of a fully automated office without paper. However currently it seems that instead of eliminating paper we actually have more of it due to the fact that the promise of a paperless office has only been partially realised and much more should be done to fully understand, implement and adopt this system.
There are many definitions of ‘paperless’ but the implied meaning is for a given process or function to be able to function without relying on paper as an input or output. Paper is used to capture data (in the form of forms, applications, surveys, contracts, etc.) in order to transport the data to a person operating the process that relies on the data. Paper is also used to output data, reports and charts to share with people who make decisions in regards to the process. Being truly paperless is mainly aimed at being “paper-lessened” or “less papered” 1.
The aim of achieving paperless systems that improve data capture and management led to several developments in clinical research during the recent years that eventually led to major changes to existing procedures. However, going paperless is still considered to be in the best interests of clinical research organisations (CROs)/ Independent Ethic committees (IECs)/ Institutional Review Boards (IRBs) to remain competitive because a paperless clinical trial would lead to a consistent and streamlined framework. All major regulatory authorities like FDA, EMEA etc. also advocate adoption of technology to increase the efficiency; hence the adoption of this framework should be the goal of any organisation involved in clinical research.
The local regulatory DCG(I) has also implemented online submission process through SUGAM portal to scrutinise the applications through e-Governance. Implementation of SUGAM portal has brought simplicity, transparency, reliability, accountability, timeliness and also simplified ease of business. It is the project of national importance that directly reflects the Government’s Digital India initiatives and is a major influence in bringing reforms in the Indian pharma industry 2.
According to the global survey performed by Veeva Systems in 2015 on use of paperless TMF: annual CRO report; more than 57 per cent of CROs reported improved audit- and inspectionreadiness as a result of adopting electronic Trial Master Files (eTMFs). Majority of them specifically cited a reduction in missing documents (92 per cent); misfiled documents (89 per cent); duplicate documents (86 per cent); incomplete documents and/ or missing signatures (84 per cent); and expired documents (81 per cent) 3. Development of a paperless system which is impregnable, adaptable and durable is always considered as a stumbling block due to several major concerns including interoperability. While, the increasing cost pressures and complexities of clinical research demand organisations to become more efficient at adopting paperless systems 4.
THE CURRENT STATE OF IECs vs eIECs
Independent Ethics Committees (IECs) play a key role in the oversight of clinical trials. The current functioning of IECs mainly involve significant amount of paperwork, increasing the routing and storage costs; traceability issues; delays in sharing and collaborating the documents; difficulties in sharing the files across remote locations; risk of backup and disaster recovery; lack of quick access to the documents; archival problems and extensive time in training the new personnel. The QCR helps IECs to resolve these difficulties and attain the dream of being paperless by aiding to perform work without printing a single sheet of paper. The benefits of using Electronic Independent Ethics Committees (eIECs) against the current system of IECs are discussed below in table 1.
HOW TO ACHIEVE A PAPERLESS IEC – CHALLENGES
The tools and methods to go paperless have been around for years however only few people have built the expertise in using these tools and methods. More importantly, few companies have the resources to attempt automation with their own resources.
The initial approach to going paperless is three steps for IECs:
1) Recognising cost savings from eliminating paper. Without the right incentive, no organisation can choose to evolve.
2) Looking for systems that can eliminate the paper or reduce the need for paper in the first place.
3) Partnering with a company who can provide the infrastructure, technology and service to deliver on the promise of a paperless office.
However, the challenge with eliminating paperwork is also two-fold – most IECs have found it difficult to assess the cost savings that can be recouped and the technology for automating paperwork is not obvious to most and often implemented poorly. Therefore, it is important to consider certain methodologies and technologies during initial
approach for implementing a plan to go paperless 5.
There are two main methodologies to going paperless. They include:
Systemic Approach: Any system that fully automates a process and displaces the paper originally used will take IECs paperless for that specific process. To ensure it remain fully paperless, it is important to seek and to eliminate the need to print documents that are output by the new system.
Forms platform approach: If the process requires print-perfect documents (even if IECs are not going to print them) then the best method for automating forms is to use a platform technology that integrates the data to and from your system with the forms in use. This approach is the most effective and easy to maintain when multiple documents need to be automated.
The best technology to use while being paperless is the Adobe® PDF standard. PDF, which stands for Portable Document Format, has become the de-facto standard for displaying documents that display and print the same on virtually every computer. Since the early 1990’s Adobe has evangelized the Adobe Reader product to ensure that the majority of computers have a PDF-reader on it. As a standard, PDF enables companies to secure their documents and enable features such as interactivity, form fields for data capture, dynamic links to external systems and digital signatures (plus many more features).
THE FUTURE IMAGINED eIECs
With eIECs, the operator simply needs a terminal computer to work. The IEC by implementing and adopting eIEC, not only result in being paperless but also aid in:
- Eliminating waste: It seems that every company wants to be eco-friendlier. Going with eIEC results in less or almost no printing which means less toner, ink and paper. It also means less transportation, fewer chemical bi-products in the production of toner and less material filling landfills and thus eliminating the waste.
- Implementing digital signature: One of the largest impediments to going paperless is the need for ink or ‘wet’ signatures on paper. A wet signature has been ingrained in our society and culture for hundreds of years as the way to verify that someone is committed to the transaction written on the paper.
- Increasing productivity: eIECs would save significant amount of time for ethics committee team, support staff, etc. ultimately, allowing them to spend more time to review proposals and increase productivity by 10-30 per cent. Implementing eIECs would allow easy access of data electronically rather than manually which would increase accuracy, lower costs, reduce data management time and improve productivity 5.
- Regulatory compliance issues require IECs to keep accurate records, provide thorough documentation on various aspects of clinical trials. They also require to appropriately handle personally identifiable information. Information on paper tends to be easily misplaced, or simply left lying around enabling access to the unauthorised personnel thus resulting in security issues1. eIEC helps in reducing these security risks by secured password system and limiting how much information an IEC member can take out the front door.
Although a paperless office has been promised for over 30 years, it hasn’t been delivered until now. With elimination of past roadblocks of limited technology, signatures and expertise to implement, coupled with a return-on-investment that is now easy to understand, achieving a paperless office is completely possible with eIEC and to go digital.
1. François Ragnet; The “Less Paper” Office: How to Reduce Costs, Enhance Security and be a Better Global Citizen; Available from: https://www.xerox.com/downloads/usa/en/t/TL_whitepaper_less_paper_office_Francois_Ragnet.pdf; Accessed on: 27th February 2018.
2. e-governance SUGAM Portal; Centre for development of advance computing: https://cdac.in/index.aspx?id=st_egov_sugam_a; Accessed on: 25th March 2018.
3. Mike Burton, director of CRO Alliances, Veeva Systems; White Paper: Survey Signals Contract Research Organizations Driving A Digital Revolution; Clinical Leader; October 20, 2015.
4. Gupta SK. Paperless clinical trials: Myth or reality? Indian Journal of Pharmacology. 2015;47(4):349-353. doi:10.4103/0253-7613.161247.
5. Paperless clinical trials SCORR Marketing and Applied Clinical Trials; Available From:file:///C:/Users/Bharath/Desktop/SCORR_ACT_PaperlessClinicalTrials-SurveyReport 2016.pdf; Accessed on: 04th April 2018