Abstract
Most clinical trials require the collection of enormous quantities of data at the clinical site. Traditionally, these data have been recorded on paper diary cards and case report forms (CRFs) and captured using double keystroke entry. Many factors in the drug development environment are now dictating thai sponsors consider adopting new proce-dures for clinical data capture. This report compares and contrasts a variety of these techniques from the perspective of the sponsor and the investigative site. No single process is ideal for all studies. Indeed, it is important to select procedures to harvest clinical data that fit each study, individually, so that quality, speed, and cost can all be maximized. Clearly, quality must be the first consideration. Sponsors and contractors must also consider the investigative site to assure that these new data capture techniques can be implemented by the end user.
Similar content being viewed by others
References
McFadden ET, LoPresti F, Bailey LR, et al. Approaches to data management. Control Clin Trials. 1995;16:30S–65S.
Reynolds-Haertle RA, McBride R. Single vs. double data entry in CAST. Control Clin Trials. 1992;13:487–494.
Blumenstein BA. Verifying keyed medical research data. Stat Med. 1993;12:1535–1542.
Hosking JD, Newhouse MM, Bagniewska A, et al. Data collection and transcription. Control Clin Trials. 1995;16:66S–103S.
Zhang J, Hu W. Single or double data entry: considerations based on a simple binomial model. Control ClinTrials. 1998;19:56–58.
Day S, Fayers P, Harvey D. Double data entry: what value, what price? Control Clin Trials. 1998;19:15–24.
Buchholz K, Ascoli D. The value of computer-assisted data review in the clinical development process. Drug Inf J. 1997;31:635–638.
Pimazzoni M. Global data management: a winning approach to clinical data processing. Drug lnf J. 1998;32:569–571.
Daniel DA, Nanjo-Jones N, Kirwin J, et al. Outsourcing management in the pharmaceutical industry: the early stages at four United States companies. Drug Inf J. 1997;31:111–118.
Electronic records; electronic signatures. Federal Register. 1997;62:13429–13466.
Fitzmaurice JM. Health care data standards are required for medically effective use of workstations. Int J Biomed Comput. 1994;34:331–334.
McDonald CJ, Overhage JM, Dexter P, et al. A framework for capturing clinical data sets from computerized sources. Ann Int Med. 1997;127:675–682.
Doherty JB. A new international perspective—the application of the principles of GLP to computerized systems (OECD 1995). Drug Inf J. 1997;31:883–888.
Schadow G, Fohring U, Tolxdorff. Implementing HL7: from the standard’s specification to production application. Meth Inform Med. 1998;37:119–123.
Stokes T. Computer systems validation (6 part series). Appl Clin Trials. September 1996, January 1997, February 1997, April 1997, June 1997, August 1997.
Hogan WR, Wagner MM. Free-text fields change the meaning of coded data. Proc AMIA Annu Fall Symp. 1996;517–521.
Higgins SB, Jiang K, Plummer WD Jr, et al. Pivot/Remote: a distributed database for remote data entry in multi-center clinical trials. Medinfo. 1995;8 Pt 2: 1097.
Lister J, Budin-Jones S, Palmer J, et al. How accurate are asthma diary cards? Thorax. 1989;44:343P.
Chowienczyk PJ, Lawson CP, Morris J, et al. Electronic diary to record physiological measurements. Lancet. 1992;339:251.
Hyland ME, Kenyon CAP, Allen R, et al. Diary keeping in asthma; comparison of written and electronic methods. Br Med J. 1993;306:487–489.
Chowienczyk PJ, Parkin DH, Lawson CP, et al. Do asthma patients correctly record home spirometry measurements? Br Med J. 1994;309:1618.
Tiplady B, Crompton GK, Brackenridge D. Electronic diaries for asthma. Br Med J. 1995;310:1469.
Tiplady B, Crompton GK, Dewar MH, et al. The use of electronic diaries in respiratory studies. Drug Inf J. 1997;31:759–764.
Kobak KA, Greist JH, Jefferson JW, et al. Computer-administered clinical rating scales. A review. Psy-chopharmacol. (Berl) 1996;127:291–301.
Papaconstantinou C, Krischer JP. An automated patient registration and treatment randomization system. J Med Syst. 1995;19:445–456.
Lawson ME, Brown PM, Shostak L. Results of a data imaging pilot project. Drug Inf J. 1997;31:193–196.
Diener-West M, Connor PB, Newhouse MM, et al. Feasibility of keying data from screen-displayed facsimile images in an ongoing trial: the collaborative ocular melanoma study. Control Clin Trials. 1998;19:39–40.
Weiler JM, Meltzer EO, Benson PM, et al. A dose-ranging study of the efficacy and safety of azelastine nasal spray in the treatment of seasonal allergic rhinitis with an acute model. J Allergy Clin Immunol. 1994;94:972–980.
Meltzer EO, Weiler JM, Widlitz MD. Comparative outdoor study of the efficacy, onset and duration of action, and safety of cetirizine, loratadine, and placebo for seasonal allergic rhinitis. J Allergy Clin Immunol. 1996;97:617–626.
Shiffman RN, Brandt CA, Freeman BG. Transition to a computer-based record using scannable, structured encounter forms. Arch Pediatr Adolesc Med. 1997;151:1247–1253.
Kohane IS, Greenspun P, Fackler J, et al. Building national electronic medical record systems via the world wide web. J Am Med lnf Assoc. 1996;3:191–207.
Kiuchi T, Ohashi Y, Konishi M, et al. A world wide web-based user interface for a data management system for use in multi-institutional clinical trials— development and experimental operation of an automated patient registration and random allocation system. Control Clin Trials. 1996;17:476–493.
Afrin LB, Kuppuswamy V, Slater B, et al. Electronic clinical trial protocol distribution via the world-wide web: a prototype for reducing costs and errors, improving accrual, and saving trees. J Am Med Inf Assoc. 1997;4:25–35.
Halamka JD, Szolovits P, Rind D, et al. A WWW implementation of national recommendations for protecting electronic health information. J Am Med Inf Assoc. 1997;4:458–464.
Hogan WR, Wagner MM. Accuracy of data in computer-based patient records. J Am Med Inf Assoc. 1997;4:342–355.
Sullivan E, Gorko MA, Stellon RC. A statistically-based process for auditing clinical data listings. Drug Inf J. 1997;31:647–653.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Lampe, A.J., Weiler, J.M. Data Capture from the Sponsors’ And Investigators’ Perspectives: Balancing Quality, Speed, and Cost. Ther Innov Regul Sci 32, 871–886 (1998). https://doi.org/10.1177/009286159803200403
Published:
Issue Date:
DOI: https://doi.org/10.1177/009286159803200403