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HomeArticlesVol 30,2020 No.2Detail

COVID-19 Clinical Trial Case Report Form and its Application Instructions

Published on Feb. 18, 2020Total Views: 19132 timesTotal Downloads: 5508 timesDownloadMobile

Author: Jing-Jing ZHANG 1, 2 Yan LIU 1 Ying CHEN 1, 2 Xiao-Yu ZHANG 1 Xue-Cheng ZHANG 2, 3 Heng-Heng DAI 1, 2 Yin JIANG 1, 2 Hong-Cai SHANG 1, 4*

Affiliation: 1. Dongzhimen Hospital, University of Chinese Medicine, Beijing 100700, China 2. Beijing University of Chinese Medicine, Beijing 100029, China 3. Guang' an Men Hospital, China Academy of Chinese Medical Science, Beijing 100053, China 4. International Evidence-Based Chinese Medicine Institute, Beijing University of Chinese Medicine, Beijing 100029, China

Keywords: 2019-nCoV COVID-19 Case report form Clinical trial

DOI: 10.12173/j.issn.1004-5511.2020.02.08

Reference: Zhang JJ, Liu Y, Chen Y, Zhang XY, Zhang XC, Dai HH, Jiang Y, Shang HC. COVID-19 Clinical Trial Case Report Form and its Application Instructions[J].Yixue Xinzhi Zazhi, 2020, 30(2): 116-123. DOI: 10.12173/j.issn.1004-5511.2020.02.08.[Article in Chinese]

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Abstract

The number of inpatients of COVID-19 is increasing, and a number of clinical studies have been registered in China to seek effective treatment. However, how to improve the comparability of clinical data be-tween different trials, improve the efficiency of clinical trial data collection and reduce the waste of clinical re-sources is one of the key issues in clinical research during the epidemic. According to the clinical data characteris-tics of COVID-19 inpatients, Oxford University International Severe Acute Respiratory and emerging Infection Consortium has developed a free electronic version of case report form (eCRF). This paper introduces the struc-ture and content of the eCRF and how to use it in detail.

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References

1.World Health Organization. WHO Director-General's statement on IHR Emergency Committee on Novel Coronavirus (2019-nCoV)[EB/OL]. (2020-01-30)[Access on 2020-02-14]. https://www.who.int/dg/speeches/detail/who-director-general-s-statement-on-ihr-emergency-committee-on-novel-coronavirus-(2019-nCoV)

2.World Health Organization. Naming the coronavirus disease (COVID-19) and the virus that causes it[EB/OL]. (2020-02-11)[Access on 2020-02-14]. https://www.who.int/zh/emergencies/diseases/novel-coronavirus-2019/technical-guidance/naming-the-coronavirus-disease-(covid-2019)-and-the-virus-that-causes-it.

3.国家卫生健康委员会. 截止2月13日24时新型冠状病毒感染的肺炎疫情最新情况[EB/OL]. [2020-02-14]. http://www.nhc.gov.cn/xcs/yqtb/202002/553ff43ca29d4fe88f3837d49d6b6ef1.shtml.

4.2019-nCoV CRF-ISARIC. Case Record Form-English[EB/OL]. [Access on 2020-01-29]. https://media.tghn.org/medialibrary/2020/01/ISARIC_nCoV_CRF_V1.2_28Jan2020_b97Y5Oe.pdf.

5.Huang C, Wang Y, Li X, et al. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, Chi-na[J]. Lancet, 2020, 395(10223): 497–506. DOI: https://doi.org/10.1016/S0140-6736(20)30183-5.

6.2019-nCoV CRF-ISARIC. Data Sharing Agreement (DSA)[EB/OL]. [Access on 2020-01-29]. https://isaric.tghn.org/site_media/media/medialibrary/2020/01/nCoV_Data_Platform_Terms_of_Data_Submission_24Jan2020.pdf.

7.2019-nCoV CRF-ISARIC. REDCap Brief[EB/OL]. [Access on 2020-01-29]. https://isaric.tghn.org/site_media/media/medialibrary/2020/01/REDCap_nCoV_CRF_BRIEF_v1.0_22Jan2020_qvV55y7.pdf.

8.2019-nCoV CRF-ISARIC. REDCap Data Entry Guide Guide[EB/OL]. [Access on 2020-01-29]. https://isaric.tghn.org/site_media/media/medialibrary/2020/01/nCoV_REDCap_Data_Entry_v1.1_28Jan2020.pdf.

9.2019-nCoV CRF-ISARIC. REDCap Data Query[EB/OL]. [Access on 2020-01-29]. https://isaric.tghn.org/site_media/media/medialibrary/2020/01/nCoV_REDCap_Data_Query_v1.1_28Jan2020.pdf.

10.2019-nCoV CRF-ISARIC. Ethics approval request template letter[EB/OL]. [Access on 2020-01-29]. http://isaric.tghn.org/site_media/media/medialibrary/2020/01/nCoV_Ethics_Template_v1.0_24Jan2020_AwK4Dg7.docx.

11.2019-nCoV CRF-ISARIC. Statement on data sharing in public health emergencies[EB/OL]. [Access on 2020-01-29]. https://wellcome.ac.uk/press-release/statement-data-sharing-public-health-emergencies.

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