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 that sponsors consider adopting new procedures 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.
McFaddenETLoPrestiFBaileyLRApproaches to data management. Control Clin Trials.1995;16:30S–65S.
2.
Reynolds-HaertleRAMcBrideR. Single vs. double data entry in CAST. Control Clin Trials.1992;13: 487–494.
3.
BlumensteinBA. Verifying keyed medical research data. Stat Med.1993;12:1535–1542.
4.
HoskingJDNewhouseMMBagniewskaAData collection and transcription. Control Clin Trials.1995;16:66S–103S.
5.
ZhangJHuW. Single or double data entry: considerations based on a simple binomial model. Control Clin Trials.1998;19:56–58.
6.
DaySFayersPHarveyD. Double data entry: what value, what price?Control Clin Trials.1998;19: 15–24.
7.
BuchholzKAscoliD. The value of computer-assisted data review in the clinical development process. Drug Inf J.1997;31:635–638.
8.
PimazzoniM. Global data management: a winning approach to clinical data processing. Drug Inf J.1998;32:569–571.
9.
DanielDANanjo-JonesNKirwinJOutsourcing management in the pharmaceutical industry: the early stages at four United States companies. Drug Inf J.1997;31:111–118.
FitzmauriceJM. Health care data standards are required for medically effective use of workstations. Int J Biomed Comput.1994;34:331–334.
12.
McDonaldCJOverhageJMDexterPA framework for capturing clinical data sets from computerized sources. Ann Int Med.1997;127:675–682.
13.
DohertyJB. A new international perspective—the application of the principles of GLP to computerized systems (OECD 1995). Drug Inf J.1997;31: 883–888.
14.
SchadowGFöhringUTolxdorffImplementing HL7: from the standard's specification to production application. Meth Inform Med.1998;37:119–123.
15.
StokesT. Computer systems validation (6 part series). Appl Clin Trials. September 1996, January 1997, February 1997, April 1997, June 1997, August 1997.
16.
HoganWRWagnerMM. Free-text fields change the meaning of coded data. Proc AMIA Annu Fall Symp. 1996;517–521.
17.
HigginsSBJiangKPlummerWDJr.Pivot/Remote: a distributed database for remote data entry in multi-center clinical trials. Medinfo. 1995;8 Pt 2: 1097.
18.
ListerJBudin-JonesSPalmerJHow accurate are asthma diary cards?Thorax. 1989;44:343P.
19.
ChowienczykPJLawsonCPMorrisJElectronic diary to record physiological measurements. Lancet. 1992;339:251.
20.
HylandMEKenyonCAPAllenRDiary keeping in asthma; comparison of written and electronic methods. Br Med J.1993;306:487–489.
21.
ChowienczykPJParkinDHLawsonCPDo asthma patients correctly record home spirometry measurements?Br Med J.1994;309:1618.
22.
TipladyBCromptonGKBrackenridgeD. Electronic diaries for asthma. Br Med J.1995;310:1469.
23.
TipladyBCromptonGKDewarMHThe use of electronic diaries in respiratory studies. Drug Inf J.1997;31:759–764.
24.
KobakKAGreistJHJeffersonJWComputer-administered clinical rating scales. A review. Psychopharmacol. (Berl) 1996;127:291–301.
25.
PapaconstantinouCKrischerJP. An automated patient registration and treatment randomization system. J Med Syst.1995;19:445–456.
26.
LawsonMEBrownPMShostakL. Results of a data imaging pilot project. Drug Inf J.1997;31:193–196.
27.
Diener-WestMConnorPBNewhouseMMFeasibility of keying data from screen-displayed facsimile images in an ongoing trial: the collaborative ocular melanoma study. Control Clin Trials.1998;19:39–40.
28.
WeilerJMMeltzerEOBensonPMA 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.
29.
MeltzerEOWeilerJMWidlitzMD. 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.
30.
ShiffmanRNBrandtCAFreemanBG. Transition to a computer-based record using scannable, structured encounter forms. Arch Pediatr Adolesc Med.1997;151:1247–1253.
31.
KohaneISGreenspunPFacklerJBuilding national electronic medical record systems via the world wide web. J Am Med Inf Assoc.1996;3: 191–207.
32.
KiuchiTOhashiYKonishiMA 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.
33.
AfrinLBKuppuswamyVSlaterBElectronic 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.
34.
HalamkaJDSzolovitsPRindDA WWW implementation of national recommendations for protecting electronic health information. J Am Med Inf Assoc.1997;4:458–464.
35.
HoganWRWagnerMM. Accuracy of data in computer-based patient records. J Am Med Inf Assoc.1997;4:342–355.
36.
SullivanEGorkoMAStellonRC. A statistically-based process for auditing clinical data listings. Drug Inf J.1997;31:647–4553.
