LBPS 02-12 AN INTEGRITY ANALYSIS OF CHINA AND FOREIGN CASE REPORT FORMS BASED ON STANDARDS OF CDISC

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Abstract

Objective:

To compare the defect situation of elements in China and Foreign Case Report Form (CRF) based on the standards of Clinical Data Interchange Standards Association (CDISC).

Design and Method:

We collected 109 Chinese and 65 foreign CRF from the Ethics Committee of the Third Xiangya Hospital in the past six years. The CRF integrity questionnaire was designed according to the Study Data Tabulation Model of CDISC to analysis the difference of defect situation in domestic and foreign CRF.

Results:

The recording ratios of medical history (79.8% VS 93.8%, P = 0.012), efficacy evaluation (27.5% VS 64.6%, P = 0.000) and other eleven elements in domestic CRFs are significantly lower than those in foreign CRFs. The recording ratios of compliance evaluation form (24.8% VS 33.8%, P = 0.198), marital status (11.9% VS 20%, P = 0.148) and other five elements in both domestic and foreign CRFs are very low.

Conclusions:

Compared with foreign CRF, the integrity of medical history and efficacy evaluation are overlooked in domestic CRF. Domestic and foreign CRF should improve the integrity of compliance evaluation form, marital status and other five elements.

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