Paperless Research Paper
1. Mitchel J, Moncrieffe A, Grimes I, Tantsyura A, Nadler V, Harnevo L, et al. The paperless trial, past, present and future. Eur Pharm Contract. 2007. [Last accessed on 2014 Jul 20]. pp. 72–74. Available from: http://www.targethealth.com/PDF/Articles/EPC_Autumn_2007_Target_Health.pdf .
2. Mitchel JT, Cho T, Gittleman DA, Markowitz JM, Kim YJ, Choi J, et al. Time to change the clinical trial monitoring paradigm results from a multicenter clinical trial using a quality by design methodology, risk-based monitoring and real-time direct data entry. Appl Clin Trials. 2014. [Last accessed on 2014 Jul 23]. Available from: http://www.appliedclinicaltrialsonline.com/appliedclinicaltrials/ClinTech/Time-to-Change-the-Clinical-Trial-Monitoring-Parad/ArticleStandard/Article/detail/833038?contextCategoryId=50216 .
3. Missinou MA, Olola CH, Issifou S, Matsiegui PB, Adegnika AA, Borrmann S, et al. Short report: Piloting paperless data entry for clinical research in Africa. Am J Trop Med Hyg. 2005;72:301–3.[PubMed]
4. Choi B, Drozdetski S, Hackett M, Lu C, Rottenberg C, Yu L, et al. Usability comparison of three clinical trial management systems. AMIA Annu Symp Proc 2005. 2005 921. [PMC free article][PubMed]
5. Payne PR, Greaves AW, Kipps TJ. CRC Clinical Trials Management System (CTMS): An integrated information management solution for collaborative clinical research. AMIA Annu Symp Proc 2003. 2003 967. [PMC free article][PubMed]
6. Bose A, Das S. Trial analytics – A tool for clinical trial management. Acta Pol Pharm. 2012;69:523–33.[PubMed]
7. Starren JB, Payne PR, Kaufman DR. Human computer interaction issues in Clinical Trials Management Systems. AMIA Annu Symp Proc 2006. 2006 1109. [PMC free article][PubMed]
8. Smyth M. Moving towards an electronic environment. Int Clin Trials. 2010. [Last accessed on 2014 Jul 25]. Available from: http://www.samedanltd.com/magazine/13/issue/126/article/2593 .
9. Obeid JS, Gerken K, Madathil KC, Rugg D, Alstad CE, Fryar K, et al. Development of an electronic research permissions management system to enhance informed consents and capture research authorizations data. AMIA Jt Summits Transl Sci Proc. 2013;2013:189–93.[PMC free article][PubMed]
10. Sanderson IC, Obeid JS, Madathil KC, Gerken K, Fryar K, Rugg D, et al. Managing clinical research permissions electronically: A novel approach to enhancing recruitment and managing consents. Clin Trials. 2013;10:604–11.[PMC free article][PubMed]
11. Limaye N. Data management Redefined. Perspect Clin Res. 2010;1:110–2.[PMC free article][PubMed]
12. Shah J, Rajgor D, Pradhan S, McCready M, Zaveri A, Pietrobon R. Electronic data capture for registries and clinical trials in orthopaedic surgery: Open source versus commercial systems. Clin Orthop Relat Res. 2010;468:2664–71.[PMC free article][PubMed]
13. Mitchel JT, Kim YJ, Choi J, Park G, Cappi S, Horn D, et al. Evaluation of data entry errors and data changes to an electronic data capture clinical trial database. Drug Inf J. 2011;45:421–430.[PMC free article][PubMed]
14. Walther B, Hossin S, Townend J, Abernethy N, Parker D, Jeffries D. Comparison of electronic data capture (EDC) with the standard data capture method for clinical trial data. PLoS One. 2011;6:e25348.[PMC free article][PubMed]
15. Sahoo U, Bhatt A. Electronic data capture (EDC) – A new mantra for clinical trials. Qual Assur. 2003;10:117–21.[PubMed]
16. Pavlovic I, Kern T, Miklavcic D. Comparison of paper-based and electronic data collection process in clinical trials: Costs simulation study. Contemp Clin Trials. 2009;30:300–16.[PubMed]
17. Babre D. Electronic data capture – Narrowing the gap between clinical and data management. Perspect Clin Res. 2011;2:1–3.[PMC free article][PubMed]
18. Lu Z, Su J. Clinical data management: Current status, challenges, and future directions from industry perspectives. Open Access J Clin Trials. 2010;2:93–105.
19. Coorevits P, Sundgren M, Klein GO, Bahr A, Claerhout B, Daniel C, et al. Electronic health records: New opportunities for clinical research. J Intern Med. 2013;274:547–60.[PubMed]
20. Powell J, Buchan I. Electronic health records should support clinical research. J Med Internet Res. 2005;7:e4.[PMC free article][PubMed]
21. Murphy EC, Ferris FL, 3rd, O’Donnell WR. An electronic medical records system for clinical research and the EMR EDC interface. Invest Ophthalmol Vis Sci. 2007;48:4383–9.[PMC free article][PubMed]
22. Yamamoto K, Yamanaka K, Hatano E, Sumi E, Ishii T, Taura K, et al. An eClinical trial system for cancer that integrates with clinical pathways and electronic medical records. Clin Trials. 2012;9:408–17.[PubMed]
23. Hanrahan D. Boosting Clinical Trial Recruitment with Electronic Health Records. HITLAB August 28. 2013. [Last accessed on 2015 Feb 27]. Available from: http://www.hitlab.org/healthy-innovations/2013/8/28/boosting-clinical-trial-recruitment-with-electronic-health-records .
24. Geiger K. Cloud computing in pharmaceutical R and D: Business risks and mitigations. Curr Opin Drug Discov Devel. 2010;13:279–85.[PubMed]
25. Divate U, Das S, Bhosale N, Divate P. Best practices sharing: Setting up a professional clinical research unit in India. Perspect Clin Res. 2014;5:37–40.[PMC free article][PubMed]
26. Stantchev V, Colomo-Palacios R, Niedermayer M. Cloud computing based systems for healthcare. Scientific World Journal 2014. 2014 692619. [PMC free article][PubMed]
27. Garg V, Arora S, Gupta C. Cloud computing approaches to accelerate drug discovery value chain. Comb Chem High Throughput Screen. 2011;14:861–71.[PubMed]
28. Schlerf R, Aharoni G. The value of digital signatures in E-clinical applications. [Last accessed on 2015 Feb 27];Appl Clin Trials. 2007 16:91. Available from: http://www.appliedclinicaltrialsonline.com/value-digital-signatures-e-clinical-applications .
29. US Food and Drug Administration. CFR. Code of Federal Regulations Title 21. April 1. 2014. [Last accessed on 2015 Feb 27]. Available from: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=11 and showFR=1 .
30. Paul J, Seib R, Prescott T. The Internet and clinical trials: Background, online resources, examples and issues. J Med Internet Res. 2005;7:e5.[PMC free article][PubMed]
31. Formica M, Kabbara K, Clark R, McAlindon T. Can clinical trials requiring frequent participant contact be conducted over the Internet? Results from an online randomized controlled trial evaluating a topical ointment for herpes labialis. J Med Internet Res. 2004;6:e6.[PMC free article][PubMed]
32. McAlindon T, Formica M, Kabbara K, LaValley M, Lehmer M. Conducting clinical trials over the internet: Feasibility study. BMJ. 2003;327:484–7.[PMC free article][PubMed]
33. Weng C, Li Y, Berhe S, Boland MR, Gao J, Hruby GW, et al. An Integrated Model for Patient Care and Clinical Trials (IMPACT) to support clinical research visit scheduling workflow for future learning health systems. J Biomed Inform. 2013;46:642–52.[PMC free article][PubMed]
34. El Fadly A, Daniel C, Bousquet C, Dart T, Lastic PY, Degoulet P. Electronic Healthcare Record and clinical research in cardiovascular radiology. HL7 CDA and CDISC ODM interoperability. AMIA Annu Symp Proc. 2007:216–20.[PMC free article][PubMed]
35. Krishna R, Kelleher K, Stahlberg E. Patient confidentiality in the research use of clinical medical databases. Am J Public Health. 2007;97:654–8.[PMC free article][PubMed]
36. Krishnankutty B, Bellary S, Kumar NB, Moodahadu LS. Data management in clinical research: An overview. Indian J Pharmacol. 2012;44:168–72.[PMC free article][PubMed]
37. Ene-Iordache B, Carminati S, Antiga L, Rubis N, Ruggenenti P, Remuzzi G, et al. Developing regulatory-compliant electronic case report forms for clinical trials: Experience with the demand trial. J Am Med Inform Assoc. 2009;16:404–8.[PMC free article][PubMed]
38. Ohmann C, Kuchinke W, Canham S, Lauritsen J, Salas N, Schade-Brittinger C, et al. Standard requirements for GCP-compliant data management in multinational clinical trials. Trials. 2011;12:85.[PMC free article][PubMed]
39. Parekh S. Electronic data capture in clinical trials: Does the emerging world still lag behind in EDC adoption? Appl Clin Trials. 2013. [Last accessed on 2015 Feb 27]. p. 22. Availablefrom: http://www.appliedclinicaltrialsonline.com/electronic-data-capture-clinical-trials .
40. Thriemer K, Ley B, Ame SM, Puri MK, Hashim R, Chang NY, et al. Replacing paper data collection forms with electronic data entry in the field: Findings from a study of community-acquired bloodstream infections in Pemba, Zanzibar. BMC Res Notes. 2012;5:113.[PMC free article][PubMed]
41. Babre DK. Clinical data interchange standards consortium: A bridge to overcome data standardisation. Perspect Clin Res. 2013;4:115–6.[PMC free article][PubMed]
42. Ohmann C, Kuchinke W. Future developments of medical informatics from the viewpoint of networked clinical research. Interoperability and integration. Methods Inf Med. 2009;48:45–54.[PubMed]
43. Klein A, Prokosch HU, Müller M, Ganslandt T. Experiences with an interoperable data acquisition platform for multi-centric research networks based on HL7 CDA. Methods Inf Med. 2007;46:580–5.[PubMed]
Doing business without paper can offer a number of appealing benefits to many companies. But there are some significant obstacles that, so far, have made it difficult to become a completely paperless office. That's why businesses may want to consider the advantages and disadvantages of a paperless office before they go in one direction or the other.
Deborah Sweeney, CEO of MyCorporation, an online incorporation service based in Calabasas, California, sees easier collaboration and sharing as a major advantage of digital documents over paper ones.
"One of the pros of paperless is that it is all in an electronic form and easily accessible by multiple people," Sweeney says. "The documents are easier to manage and do not get lost."
Facilitated teamwork is also a plus of having a paperless office, says Walter Thinfen, president and CEO of Visioneer, a Pleasanton, California-based imaging solutions provider.
"Whether it's email, file sharing or cloud storage, a digital office makes it much easier to share documents, especially in today's workplace where everything is highly distributed," Thinfen says.
In addition to easing collaboration for employees of a business, many clients find going paperless to be more efficient too, according to Lawrence Miles, principal at Los Angeles wealth management firm AdvicePeriod.
"They love not getting the stacks of statements," Miles says.
Improved audit trails constitute another benefit of digital documents, Thinfen adds. "You can enable track changes, track edits and compare documents," he says. "In a paper format that's very difficult."
Saving Pennies From Going Paperless
Cost savings may be among the most significant benefits of having a paperless office.
"Going paperless significantly cuts costs in paper, toner, maintenance and, most importantly, time," Thinfen says.
Employees may be able to find, access and share digital documents more readily compared to paper forms. And electronic file processing can also be automated, potentially producing greater savings.
Digital documents are also generally regarded as preferable for the environment because they don't require cutting down trees or physical transport.
"More and more companies are looking to be known as socially responsible companies," Thinfen notes. And one way businesses can demonstrate commitment to sustainable business practices is by using little or no paper.
Some consider electronic information easier to store than paper files. Digital records consume a fraction of the space of comparable paper documents. Making backup copies, as well as storing and accessing backups in safe off-site locations, can be simpler, quicker and more secure with digital documents.
"The recent hurricanes, Harvey and Irma, were perfect examples of why digital is better than paper," says John Waldmann, founder and CEO of Homebase, a San Francisco-based provider of electronic solutions for managing hourly employees. "So many businesses lost the paper records they had due to storm damage and flooding."
Waldmann says his customers affected by the disasters were able to quickly restore critical records from cloud-based storage and get back into operation.
Potential Paperless Office Problems
While eliminating paper has its advantages, there are reasons why the paperless office has yet to become ubiquitous. Among the potential problems holding paperless offices back are worries about the effects of power outages hampering access to crucial records. There is also the risk of malware infecting digital documents.
But perhaps the biggest obstacle is that some customers, vendors and employees simply prefer paper. For example, many of the financial services companies Miles does business with require pen-and-ink signatures on paper.
"One company might accept an electronic signature, another might not," he says.
Security-related concerns about data breaches could also keep some businesses from completely embracing the paperless vision. Thinfen says that companies need to be particularly attentive to security procedures exercised by third-party services that digitize paper-based information.
A Paperless Program
Businesses that are attempting to reduce or eliminate paper can perhaps best approach it as a change management program. Ideally, all parties that will be affected will participate in planning, specifying and implementing it.
"It needs to extend outward to incorporate conversations with supplies and customers," Thinfen says. "Everybody needs to be on the same wavelength."
Waldmann advises seeking technology providers that work well with other technology solutions.
"Also look for tech tools that are easy to use for you, your managers and your employees," he says. "Good digital solutions shouldn't require much training."
Although obstacles to a fully paperless office remain, before long these may be overcome by the pressures of competition. As business becomes steadily more tech-centric, companies may simply be unable to afford to keep using non-digital information in almost any form.
"You have to have a strategy around going paperless in order to fully embrace artificial intelligence, predictive analytics and big data," Thinfen says. He anticipates that those holding out on shedding their paper past will give in, and within a few years the truly paperless office will be not just a reality, but a requirement.
Miles agrees, and says that because of the competitive advantages of being all-digital, he regards achieving paper-free operations as essential.
"In our opinion, it's not only feasible to go completely paperless, but you have to," he says. "It's not really a nice-to-have, so much as it's a must-have."
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Photo: Getty Images
—Walter Thinfen, president/CEO, Visioneer