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1 w wz 16«1y Kor. J. Clin. Pharm., Vol. 16, No x w$btf3fqpsu'psn û w m w Department of Statistics, Chonnam National University Eunsik Park College of Natural Sciences, Chonnam National University In clinical trials, it is important to have well designed case report forms (CRF) in order to obtain good quality of data. If CRF design at the first stage of your study goes wrong, after all efforts have been made, you may find practical difficulties in data analysis at the final stage of your study because of incomplete or wrong information. In this paper, the following rules fundamental to CRF design are introduced: rules in general, rules of format or style, categorized responses, forms with multiple records per subject, and international studies. Investigators are well aware of research goals, however sometimes they do not know how to express it on CRF. If they understand the rules fundamental to CRF design, time for CRF development will be saved and CRF completeness will be enhanced. Key words - design of case report forms, data management, clinical trial vx l» w» w, w (form) v w w ƒ w. w w, ƒ ù š, ƒw ü» w»ƒ š w., x w x ü w»ƒ. 1) x w, g x w CRF w, 100 e x ƒ š., ƒ w CRF ü š, š CRF mw e, w w w, v w w, ù ƒ w w. w Õ v w w ƒ CRF r ƒ z ƒ ƒw. w w, w ƒ, w z w v ƒ»» w., Correspondence to : û w w w 1y 419y Ÿ Ÿ 333 Tel: , Fax: [email protected]» w w ù, w w» w w w. w w ƒw ù w, f w e š ƒw,. w w z y»»ƒ š, r ù š,, r,, w y y ƒ ë w,, t e, k, š, vp w. Pocock w x w w š w w š w. 2) x x w š,, x w y sƒ» w w. (form design), w w š, w». 1) x w, CRF w w. 3) CRF» w. CRF ƒ, ƒ ù, ù, ù, yw ù, w z x w ƒ». CRF 40
2 x w Case Report Form 41 ƒ v mg ³ w, w» w š w. w e w e wš { z š ƒ e w. CRF v w» e ƒ x ù wš w. e CRF w», m w wì w w w w. w š w, w w» w Õ v w w w w., v w w w û w. 3) w w x w k., û. CRFƒ r, r w w» w ppw w w. $3'» CRF w w v mg, v mg w w w.,» w w ƒ w CRF wš,, w w w v mg w. w CRF x xƒ û ã ù, d y w» w d ù kw, v mg w w. CRF w» w v w w, w w w m ƒ y w v mg l CRF wì w ƒ w. CRF» w w w, ª y w. ü x sww CRF w» e w w z CRF w. $3' CRF CRF» w w w. t y š, v mg w. ü a) CRF r x, b) CRF w w, c) e, ú,» w sww. w, ƒƒ, p w w œw, CRF w yw, yw». w x w š ü ƒ w ü» g w š w., w» w, w, (concomitant medication form) ƒ» w w w œw,». $3' CRF,, w w w ƒ w, yw w. w, w ywš, wš, w, óù z š w. 4) vx CRF r vx y v w t»w w, CRF r ƒ vx CRF w y w» w. ù,,, xe y vx w ƒ ü» w. vx vx š y (initial) w. x x w w w z,»k ü ƒ» w w.,,, y ƒ ü» w x. ü» w x x w ƒ. w, l w ü w» w ƒ r, x w { v w. yw» w, CRF»» w, œ w w w. fuly l w w š w, z w
3 42 Kor. J. Clin. Pharm., Vol. 16, No. 1, 2006 w. x», w w CRF sww d w š w w. w k w» w ƒ, w w w w. w w k w x, ƒ. 5), mw w., ƒ l p w x w w, ƒ k w ƒ. w x š d w w, y w d x w w y. t y t y ww ù w, w ƒ w w wù. t y ; a) w w w. ( : e :, / /z, e, e, e, ) b) w d w. c) w x w.» w, w œ w w ƒ. œ ƒ w w» w, ƒƒ ƒ w l, ƒƒ g vx w w. j (screening form) vx š y w» w, w, ƒ w vx w». CRF w, v w w w. w š w w. w» w š w, ù w» w xk yw qw. 6) CRF v w š wš y w» w. w e ƒƒ w» w, w.» w, y w w. r y»» r y r ƒ» w y CRFƒ w» w v w. r y w. 4 r, r y 1/4 w. ƒ CRF ew. w ù, w w, w ù»ƒ. w w w ew wš, ƒƒ w e w. t r w. w x ƒ ww. ex CRF w» ex w w.» w w ex» w œ w w.,» w w, w» w. œ w w y w. w w» w» w 0 v w w w w.,» w œ. w, 0 w v w š w w,» y z ý., sw» w d w, ex w w w.» w z š» w w. w,
4 x w Case Report Form 43, ú w w w w w.,» w» w ù y wù kw w w w. œ y y w w œ y ƒƒ w y š w, w w w e w. w w r w w w, CRF»,, y ƒ y w w» w. x k CRF x» w e x» w» w ý y w w. w w kw» w, w w y X y wù kw w w. (, y ). x» x l y w w., w w, a) ý Male ý Female y b) ý 1 Male ý 2 Female x txw. a) w, û, l M, Male, û, û y 1 l y w» ƒ. CRF l g b) t»w w r w œw. t»w x ƒ ù x p w. ù x w, j» y ù w., w y / / m / y / / / m ùk ü ù y w ƒ. w w» w w CRF. ƒ / m / ƒw ù ƒƒ yw w ü CRF ƒw j» q w x. s x w sww w w., CRF x w w,» ƒ t»w w ƒ w. x y ƒ, w w vx ƒ š w., w û vx ù, y w w w., û y ƒ sw vx w w w wù ƒw v w. k w w w k w. vx w, x w» w w y. Õ w v ƒ, vx w ù, CRF» w, y w w ƒ y vw» w v mg w w w., kw w w wù kw w w. w w x w w w., m w w w / wš, / ƒ / m / w w, ù y w. vx g x w w e vx w w g w., vx g ƒ š š, vx» ƒ q w» w p w ƒ v w. t» g x w x t (grid) w w. x t» w» ƒ» w» w
5 44 Kor. J. Clin. Pharm., Vol. 16, No. 1, 2006 y e k. y» š, w ƒ w w, x t ƒ», y CRF» ƒ w š» w. r y»» ù» w z w z ƒ w r w. x w x r wš y r š w r x/ y x y w. r y. y ƒ x w r y w, g ƒ» y w»ƒ. r w vx ƒ g, w r ó y w r t w w w. w, r ƒ ù. ƒ» x v w e ù ù ù. ƒvw, w w e w w. ú ú t» ù dd/mm/yyyy, dd/mmm/ yyyy y mm/dd/yyyy w (d:, m:, y: ). ù w x w ù ú t» k w ù w w. w t» ú» w ¼ y» w ú ú» w œ w. F$3' e-crf» w CRF CRF w x, m š l w w r w œw. 7) s w š l w m š ƒ w. e-crf ful yw vx ƒ l ƒ w wš, ƒ w p w l ƒ w w. ù ƒ w ƒ x» œ ƒ w ƒwš e- CRF ƒ ( l ù ù e-crf w» w w. CRF v w» CRF.» ù e š w, w. 8), w e xk w» w w. z ƒ, w ƒ w ƒw. CRF x w ¾ w m v w., x ƒ w w t š, CRF txw w ƒ. w e w, CRF w m yw w û w w w. š x 1. Singer SW, Meinert CL. Format-independent data collection forms. Controlled Clinical Trials 1995; 16: Pocock SJ. Clinical trials: A practical approach, 1st ed. Chichester: John Wiley and Sons, 1983; Friedman LM, Furberg CD, DeMets DL. Fundamentals of Clinical Trials, 3rd ed. New York: Springer, Roberts RJ, Musick BS, Olley B et al. Data management in a longitudinal cross?cultural study. Statistics in Medicine 2000; 19: Calvert WS, Ma MJ. Concepts and Case studies in Data
6 x w Case Report Form 45 Management, 1st ed. Cary: SAS Institute Inc., Carpenter MA, Crow R, Steffes M et al. Laboratory, reading center, and coordinating center data management methods in the Jackson heart study. American Journal of the Medical Sciences 2004; 328: Robertson J. Cardiovascular point of care initiative: enhancements in clinical data management. Quality Management in Health Care 2003; 12: McFadden E. Management of Data in Clinical Trials, 1st ed. New York: John Wiley & Sons, 1998.
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