• The Journal of the Korea Contents Association
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• v.12 no.12
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• pp.714-720
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• 2012

With the help of information technology, it is the most important to collect clinical data correctly in clinical trials. For this, recently, in many pharmaceutical companies and Clinical Research Organizations (CRO) have tried to adopt an Electronic Case Report Form (eCRF) system. The eCRF system is a computerized system designed for collecting and managing clinical data in clinical trials. Although the eCRF is recognized as a significant system for clinical trials, until now there are no widely useable, due to the huge effort and expense at the initiatory stage of adopting eCRF system. In this study, we inquired the use of eCRF system developed for clinical trial at Korea Institute of Oriental Medicine. Especially, we focused on the time required for entering clinical data into the eCRF, hours of use, and the number of queries according to the time flow.

• Korean Journal of Clinical Pharmacy
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• v.16 no.1
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• pp.40-45
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• 2006

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.

• Journal of Sasang Constitutional Medicine
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• v.27 no.2
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• pp.222-230
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• 2015

Objectives The purpose of this study is to design a research to find clinical factors involved in the decision-making process for determining the constitutional prescription based on prospective clinical data. Methods We have created a draft of the case report form. Therefore, seven constitutional experts was interviewed for additional items to be important used to determine the constitutional prescription in clinic. Interviews were done from December 2012 to March 2014, experts per person 2-3 times, took time of about 120 minutes per interview. Since then, we developed the final case report form through the expert meeting. At the same time, the developing the electronic case report form (eCRF) and the protocol to collect constitutional treatment cases was also discussed. Results & Conclusions The items of the case report form were subject general, lifestyle, health measurement, record of expert, prescription and evaluation after medication. The part of the clinical symptoms of the record of expert allowed to be recorded in the 5-point scale for the collection of quantitative data as much as possible. Assuming a re-visit of the patient, if necessary, twice the recording were to be possible. At the same time, the eCRF and the protocol to collect constitutional treatment cases were also developed. In this study, it will be able to more objectively standardize the medical decision making process that the experts of constitutional prescription decision. As a result, it will be possible to provide the standardized constitutional medical services.

• Journal of Physiology & Pathology in Korean Medicine
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• v.21 no.1
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• pp.347-351
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• 2007

This study was done to report the improvement of second case report form(CRF) and standard operating procedure(SOP) of Tentative Korean Standard Differentiation of the Symptoms and Signs for Stroke. We were in charge of developing case report form(CRF) and educating the investigators. In the process of this project, we needed to develop standard operating procedure(SOP) for this CRF. So we made Tentative Korean Standard Differentiation of the Symptoms and Signs for Stroke and tried clinical application at Department of Oriental Internal Medicine of Wonkwang University and Daejeon University in 2005. And in this pilot study we can find out some problems and need to improve it. We strengthen the incision and exclusion criteria of CRF We canceled the Chief complains entry for efficiency. We reflected the decision of Stroke standard committee. We reduced the differentiation index of CRF to promote efficiency and accuracy. We rearranged the order of the differentiation index to promote rationality and practicality. We regulated detail item belonging to Differentiation index. We used a colloquialism in question. We inserted flow chart in SOP. We inserted picture of diagnostic index.

• The Journal of Korean Medicine
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• v.27 no.1 s.65
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• pp.204-219
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• 2006

Objectives : This study is to report the proceeding of the project sponsored by the ministry of science and technology of Korea for the stroke study 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 clinical researches and maintain the resource document and data.

• Korean Journal of Oriental Medicine
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• v.13 no.2 s.20
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• pp.127-133
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• 2007

Objectives : This study were aimed to estimate the needs for clinical research educational program development focused on oriental medicine. Methods : Department Medical Research of Korea Institute of Oriental Medicine surveyed 204 certified subjects in total by using web-based questionnaires through e-mail from Jan. 17th to Jan. 31th, 2007. Reply from 62 on-line correspondents were collected and statistically analyzed. Results : The number of clinical trial involving oriental medicine continues to increase. According to the survey, many Issues were raised as problems such as difficulty of recruitment, lack of fund and lack of stepped program. Emphasized issues were clinical research methodologies, development of protocols and case report form (CRF), and Regulations including Institutional Review Boards (IRBs) in these three consecutive education training program. Conclusion : The results of this study may contribute to the development of an educational program for oriental medicine, a program that should be taken into consideration for developing practical items, such as, problem-based learnings which reflects participants' actual needs in their works. Also this report be used for future strategy plans and execution of training program for oriental medical clinical trial.

• Journal of Sasang Constitutional Medicine
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• v.21 no.3
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• pp.107-121
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• 2009

1. Objectives: We aimed to know what are different in physiological and pathological symptoms associated with health state according to Sasang Constitution in women 2. Methods: We recruited 338 women between 10 and 80, excluding individuals who have physically or psychologically serious disease, or women in pregnancy among Korean population in Traditional Korea Clinics. We used CRF(Case Report Form, C-2009-002439) as measurement of physiological and pathological symptoms and SF-36 (Short Form-36) as measurement of health state We analyzed association between physiological and pathological symptoms and health state with Two-way ANOVA 3. Results: There are 9 different symptoms associated with health state, such as digestion state, uncomfortable problem in belly, indigestion in bad condition, abnormal sweat, night sweat, clean in urine, no problem in urine, feel heavy in chest according to Sasang constitution. 4. Conclusions: Physiological and pathological symptoms are associated with health state and some symptoms associated with health state are different according to Sasang Constitution in women.

• Journal of Physiology & Pathology in Korean Medicine
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• v.22 no.6
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• pp.1378-1382
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• 2008

This study is aim to evaluate pulse diagnosis as indicators for classification of the pattern identifications in stroke patients. To get the clinical information, we recruited the onset 1 month stroke patients through the multicenter network which consists of 13 oriental hospitals. The clinical informations about three pairs of pulse wave form and levels of their significancy based on the case report form (CRF) were collected and their distribution in each pattern identification were analyzed. The results are as follows Fire-Heat group shows high portions of floating pulse, rapid pulse and solid pulse. Qi Defficiency group has a greater portion of deep pulse, slow pulse, deficient pulse. The well-defined character of Phlegm-Retained Fluid, Yin Defficiency, Static Blood groups cannot be explained by pulse wave form. These results show a rough relationship between the pulse diagnosis and pattern identifications of stroke therefore, further studies are required to determine the pulse diagnosis as significant indicators of stroke pattern identification.

• Journal of Sasang Constitutional Medicine
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• v.22 no.2
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• pp.48-59
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• 2010

1. Objectives: Sasang Medicine has been based on different medicine approach because people were different, so, this was a little different concept about health compared to other oriental and western medicine focused on existing Yangsaeng theory. We were announced Constitution health indicators for women, and this was follow-up study designed to identify Constitutional health indicators in men. 2. Methods: We recruited 171 men between 10 and 80, excluding individuals who have physically or psychologically serious disease among Korean population in Traditional Korea Clinics. They were diagnosed by Sasang Constitution specialists and confirmed clinically with Sasang constitution drug response with past medical records. We used CRF(Case Report Form, C-2009-002439) as measurement of physiological and pathological symptoms and SF-36 (Short Form-36) as measurement of health state. We analyzed association between physiological and pathological symptoms and health state with Two-way ANOVA. 3. Results: 23 items of 82 indicators in physiological and pathological symptoms were related to the quality of life, regardless of the constitution. There are 4 different symptoms associated with health state in men, such as regular of feces, hard to fall asleep, no problem in chest, feel heavy in chest according to Sasang Constitution. 4. Conclusions: From these Results, there are different items of physiological and pathological affected the Quality of life according to Sasang Constitution.

• Journal of Physiology & Pathology in Korean Medicine
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• v.21 no.6
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• pp.1581-1585
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• 2007

To report Sensitivity and specificity about utility as diagnosis criteria for deficiency of Qi in stroke. Korean medicine doctor surveyed deficiency of Qi of the symptoms for the Stroke case report form in stroke patients within 1 month of onset. We analyzed 643 patients have diagnosed stroke, neurological deficit continued over twenty-four hours and within one month of onset, except traumatic cerebrovascular attack (EDH, SDH) using the result by medical specialist and residents diagnosed differentiation and written CRF(Case Report Forms) which based on 'Korean Standard Differentiation of the Symptoms and Signs II' in twenty multi centers. The sensitivity of "more 1/5 in major sings and 1/5 in helpful signs", "more 1/5 in major signs and 2/5 in helpful signs", "more 2/5 in major signs and 1/5 in helpful signs", "more 2/5 in major signs and 2/5 in helpful signs""more 3/5 in major signs and 1/5 in helpful signs""more 3/5 in major signs and 2/5 in helpful signs" are respectively 83%, 50%, 72%, 46%, 47%, 32%. The specificity are respectively 28%, 59%, 55%, 74%, 80%, 89%. The sensitivity(72%) and specificity(55%) of "more 2/5 in major signs and 1/5 in helpful signs" that to be implanted. Although this values are not high, after values of sensitivity and specificity should be more than current value, and then we should be able to suggest as objective diagnosing criteria.