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1 27 1 ( ) J Korean Oriental Med 2006;27(1): Development of CRF and SOPs for the Identification of Risk Factors of the Cerebrovascular Diseases in the East and West Medicine Seong-Gyu Ko, Chan-Yong Jun 1), Jong-Hyeong Park 1), Chang-Ho Han 2), Ho-Yeon Ko 3), Yoosik Yoon 3), Seon-Mi Choi 3), Woo-Sang Jung 4), Sang-Kwan Moon 4), Ki-Ho Cho 4), Young-Suk Kim 4), Hyung-Sup Bae 4) Clinical Research and Molecular Epidemiology Center, College of Oriental Medicine, Kyunghee University Department of Internal Medicine, College of Oriental Medicine, Kyungwon University, Seongnam, Korea 1) Department of Internal Medicine, College of Oriental Medicine, Dongguk University, Koyang, Korea 2) Department of Medical Research, Korean Institute of Oriental Medicine, Daejeon, Korea 3) Department of Cardiovascular and Neurology, College of Oriental Medicine, Kyunghee University, Seoul, Korea 4) Objectives : This study is to report the proceeding of the project sponsored by the ministry of science and technology of Korea for the stroke stduy titled as fundamental study for standardization and objectification of differentiation and pattern identification of symptoms of Oriental Medicine in stroke. Methods and Results : We works for clinical research and molecular epidemiology center and we are in charge of the development of case report form, education of the investigators, data entry, data validation, and analysis. In the process of this project, we need to development of standard operating procedures for development and education for the case report form. Conclusions : This study is to let researchers for Traditional Korean Medicine and clinical research know how to develop of case report form and standard operating procedures in cliniacl researches and maintain the resource document and data. Key Words: Standard Operating Procedure (SOP), Case Roport Form (CRF), Stroke : : : : (Tel : , johkiho@khmc.or.kr) (Case Report Form; CRF) 204

2 (205),. (Standard Operating Procedure; SOP) (specific function) (uniformity) (detailed) (written instruction).,,,., (efficiency), (uniformity), (safety) 1-3).,, ,., 3,,,,,.,,,,,.,,,.,,,,,,, 3, 4. 1, 2,.,,, 3, 4.,,,,,. 205

3 (206) 27 1 ( ), (Consistency), (Accuracy), (Completeness) (Clarity). 1).,.,.,.,.,.,..,,,.,. Not done No Not Done (ND)Not Applicable (NA)..,.,.,. 2) :00, 00:00..., ( ). (End of study subject summary page). Header detail,. / / (, 01/AUG/05)... 1), ICH/GCP KGCP (Korean Good Clinical Practice), (site inspection),., Code of Federal Regualtion,, GCP.,, 206

4 (207),,, (FDA Guidance ducuments and information sheets),.. GCP (Good Clinical Practice),., (deviation),,,. (Quality) (Integrity), (Safety).. 2) (1)., (ideal) (practice)., GCP..,, (how), (who), (what), (where), (where), (when), (why).,...., (staff),,,. FDA, (continuity) (consisntency),. (2).,, (needs),,,,.,,.,. (3) (title), (purpose), (policy), (scope), (responsibility), (definition) 207

5 (208) 27 1 ( ) Table 1. site evaluation visit initiation visit (visits) monitoring visit dose out visit informed consent delegation of authority source documentation general correspondence (study management) case report form completion clinical trial material management adverse experience reporting serious adverse experience management sponsor initiated site audit FDA inspection IRB approval IRB correspondence protocol amendment advertisement (procedure).,,,.,,, (functional description),,.,,.. (effective date).,.,.,, (flow chart), (step by step),.,,. (4),.,,.,,,,, 208

6 (209).,..,,,., (device). (Source documents), (KFDA).. 1),..,,. KGCP,,,,,,,,,,,,, ( ). (Source data),, ( ). (Case Report Form) (1 2 6 ). 2),,, /,,.,.,.,., ( ).. 3), (Complete and Accurate).,.,,, CRO (e.g followup ). (Routine). /CRO.., (Practical). 209

7 (210) 27 1 ( ). (flexible).... late entries.,. 4),,,, ( Subject notes),,,,,,,, /( ),, ( ),. 1,,,..,. 2,,,. 2.,,, , , 5 2, 5 7, 5 16, ,,,,,, , 6 19, 7 30, ,. 210

8 (211), 12, 13, 25, 19,..,. (Stroke, ),, 24,, WHO (, ).,,,,,,, 2, 24,,,,, ().,,,,,,.. CRO (Contract Research Organization, ).. CRO,.,, 2. ICH/GCP, KGCP, ICH IRB 3, / 2, 15,.,,. 5, 5, 4-7).,., 211

9 (212) 27 1 ( ),.,,,,. Aknowledgement : 2005 (M N ).,,,, macrophage RAW264.7 macrophage LPS, NF- B., NO PGE2, 100 / %, %., inos COX-2., LPS RAW264.7 macorphage NF- B 50, 100 / NF- B. 1. Brandt CA, Argraves S, Money R, Ananth G, Trocky NM, Nadkarni PM. Informatics tools to improve clinical research study implementation. Comtemp Clin Trials. 2005; Rico-Villademouro F, Hernando T, Sanz JL, Lopez-Alonso A, Salamanca O, Camps-C, Rosell R. BMC Med Res Methodol. 2004;25(4): : USFDA. Guidance for industry; E6 Good Clinical Practice: Consolidated Guidance ICH, 1996, April. 5.. ; Daivd H. Golden GCP rules for investigators IRB (SOP). 212

10 (213) No..,,. CRMEC (Clinical Research and Molecular Epidemiology Center),.,,,,,. : : : : : : 1) : : 2) : 200 :

11 (214) 27 1 ( ) No. 1. : 2. : 3. : 4. ICH SAH Cerebral Inf.( 9 ) 5. TOAST (8 3 ) LAA (Large Artery Atherosclerosis) CE (Cardioembolism) SVO (Small Vessel Occlusion) SOE (Stroke of other determined etiology) SUE (Stroke of Undetermined etiology) 6. Brain CT Angiography (MRA) Brain MRI ( :, ) 7. (Atrial Fibrillation) 8. UTI URI umonia reattack Seizure Bed Sores ( ) : 200

12 (215) ( ) (on awakening; sleep) (awake) Unknown 11. : A B O AB (QSCC ) ( ) (/ : ) 14. : kg 15. : cm 16. : cm 17. : cm 18. :, ( ), ( ) ( ) 19. ( ) 20., ( : ) (: ) (: /1) 21. ( ) ( )

13 (216) 27 1 ( ) 23. (, : ) ( :, : ) ( :, : ) ( :, : ) (Warning Signs of Stroke) , ( 3 ) ( 3 ) , ( 3 ) ( 3 ) (Warning signs of Stroke in TKM)

14 (217). 32. ( : ). 33. HRT (hormone replacement therapy) 34. OC (, oral contraceptive) / mon ,, ( ) ( ) ( ) 39. ( ) pack-years 40. ( ) ( ) 41. ( ) 42., 43. ( ) 1 2,,, ( ) ( )g ( )g 217

15 (218) 27 1 ( ) 44. ( ) / mon (4 ) years 45. ( ) / mon (4 ) years 46. ( /4 ) ( ) ( ) ( ) / homocysteine ( ) 52. Vit. B12 ( ) 53. folate acid ( ) 218

16 (219) 2 WBC RBC Hg Hct Platelet fibrinogen GOT(AST) GPT(ALT) Total Chol triglyceride HDL-C total lipid LDH CK FBS PP Na K Cl CRF : 200 CRF : 219

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성인용-칼라-단면-수정1030 Korean Association of Institutional Review Boards 2 3 1 Who 5 2 3 What 11 Why 17 5 6 7 Where 28 How 31 43 4 When 20 4 1 Who Research Participant Who 6 Who 7 Who 8 Who 9 (IRB) Who 10 2 What Protocol What