iCReaT(clinical research management system)

Clinical Research and Trial Management System operated by the National Institute of Health

A system that can manage the overall clinical research, from assignments, study subjects, eCRF, data extraction, report and monitoring

It is a system supported by the state and is free of charge.

System Contact

070-4607-0734
070-4607-3434

icreat@btsd.io
Contact

043-719-8962

icreat@korea.kr

Login: Once you select the version you want, it will be moved to that system.

iCReaT stands for Internet-based Clinical Reaserch and Trial Management System, built to provide evidence-based health care services more efficiently and integrated.

About iCReaT

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FAQ

FAQ

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iCReaT 소개

임상연구관리시스템: (iCReaT; 아이크릿)

internet based Clinical Research and Trial

근거 중심 보건의료서비스의 토대가 되는 임상연구의 객관적이고 효율적인 수행을 위해 과제 관리, 연구대상자 관리,
데이터 입력 및 자료추출, 모니터링, 표준화된 보고서 등 임상시험을 포함한 임상연구 자료를 관리 할 수 있는
시스템입니다.

미국 규정 21 CFR Part11(식품 및 의약품 관련 전자기록, 전자 서명에 관한 기준 및 요구사항)을 준수함으로써
임상연구 자료의 객관성과 신뢰성 향상을 추구합니다.

iCReaT ver.1은 2010년부터 운영하기 시작했으며, 속도 및 기능이 개선된 ver.2는 2017년부터 제공하고 있습니다.
또한, 2018년에 관찰연구(단면연구)에 적합한 Lite version을 개발하여 제공 중입니다.
※ ver.1은 Internet Explorer 기반 Active X가 필요한 시스템으로 `24년도에 종료

iCReaT은 국내 임상 연구자의 자발적인 연구 활동을 위한 기반을 마련하여 보건의료서비스 근거창출에 필요한 임상연구 데이터의 품질 향상에 기여하고 있습니다.

iCReaT 버전 별 주요 기능

주요 기능		Ver.2
과제 관리	일정 생성/관리
	eCRF 생성/관리
	기관 및 팀원 관리(권한)
	기관 진행 상태 관리
연구대상자 관리	대상자별 등록 및 관리
	대상자별 웹기반 무작위배정
	대상자별 일정 관리
	대상자별 eCRF 입력
데이터 관리	시스템 오류 쿼리 관리
	eCRF 오류 쿼리 관리
	Audit trail (데이터 변경 추적 관리)
자료추출	사용자 기반의 eCRF raw dataset 생성
보고서	다양한 종류의 보고서
데이터 표준화	Metadata 적용
	이상반응 용어사전	WHO-ART MedDRA
	건강보험심사평가원 약물 DB(ATC 코드 포함)

iCReaT 이용 조건 체크리스트

정부기관(보건복지부, 질병관리청 등), 공공기관에서 지원하는 국가 임상연구 또는, 연구기관, 종합병원 이상 급의
기관에서 수행하는 연구자 주도 임상연구

iCReaT 신청 방법

1

신청하려는 연구과제가 iCReaT에 협약되어 있는지 확인 또는 이용신청 되어있는 기관인지 확인한다.

* 협약기관이 아니라면 공문으로 이용신청을 한다. (담당자 문의)
2

협약 과제 또는 기관이라면 고급사용자교육(연 5회 대면 실습교육) 수료자를 과제설정담당자로 지정
(복수 가능) 하여 과제신청을 할 수 있다.
3

과제 신청시, 연구계획서와 CRF 파일을 첨부한다.
4

iCReaT 담당자 승인 후, 과제설정담당자가 eCRF를 구축 등 과제 설정을 하여 자체적으로
운영할 수 있다.

iCReaT 회원가입 안내

iCReaT Ver.2

(방문 일정이 있는 연구)

2

국립보건연구원 온라인지식플랫폼 (필수)
https://library.nih.go.kr/spec 회원가입

“iCReaT ver.2 사용자교육” 수료

iCReaT 시스템
https://icreat.nih.go.kr

회원가입(교육시스템 ID 또는 ver.2 수료번호 입력)
→ 관리자가 수료여부 확인 후 ID 승인
(임시 비밀번호 문자 발송)
iCReaT Lite

(방문일정이 없는 관찰연구 또는 단면연구)

Lite

iCReaT 시스템
https://icreat.nih.go.kr

회원가입(Lite 선택) →
관리자가 확인 후 ID 승인
(임시 비밀번호 문자 발송)

국립보건연구원 온라인지식플랫폼 (비필수)
https://library.nih.go.kr/spec 회원가입

“iCReaT Lite 사용자교육”

팀원 추가

참여 과제 책임기관에 팀원 추가 요청 > 과제 팀원관리 담당자가 사용자 추가

버전 추가 신청

추가 이용 하고자 하는 version 로그인 창에 기존 생성된 ID와 비밀번호 입력

About iCReaT

Internet based Clinical Research and Trial: (iCReaT)

iCReaT is a system that enables the objective and efficient conduct of clinical research, which is the foundation of evidence-based healthcare, by managing clinical research data, including clinical trials, such as study management, subject management, data entry and data extraction, monitoring, and standardized reports.

It enhances the objectivity and reliability of clinical research data by complying with Title 21 CFR Part 11 (United States Food and Drug Administration (FDA) regulations on electronic records and electronic signatures (ERES)).

Starting operating iCReaT ver.1 in 2010, iCReaT ver.2 with improved speed and functionality has been made available since 2017.
(iCReaT ver.1 is a system that requires Active X based on Internet Explorer (IE) and is scheduled to be decommissioned by 2024 as developer support for IE ends.)

In 2018, a lite version was developed and offered for observational studies (cross-sectional studies).

iCReaT contributes to the improvement of the quality of clinical research data for creating evidence for healthcare services by laying the foundation for the voluntary research activities of clinical researchers in Korea.

Key features of each version of iCReaT

Key features		Ver.2
Study management	Creation/management of schedules
	Creation/management of eCRF
	Management (permissions) for organizations and team members
	Management of organizational progres
Subject management	Enrollment and management of subjects
	Web-based randomization of subjects
	Schedule management for subjects
	eCRF input for subjects
Data management	Management of system error queries
	Management of CRF error queries
	Audit trail(Tracking of data changes)
Data extraction	Creation of user-based eCRF raw datasets
Reports	Various types of reports
Data standardization	Metadata application
	Glossary of adverse events	WHO-ART MedDRA
	Health Insurance Review and Assessment Service (HIRA) Drug DB (with ATC codes)

Checklist for terms of use

National clinical studies supported by government agencies (Ministry of Health and Welfare, Korea Disease Control and Prevention Agency (KDCA), etc.) or Investigator-initiated clinical research conducted at research centers, general hospitals, and higher level institutions

How to apply

1

Check if the research project you are applying for is contracted to iCReaT or if you are a contracted institution.

* If you are not a contracted organization, you must apply in writing (contact the person in charge).
2

A contracted project or organization can apply for a project by designating at least one project manager (multiple project managers are allowed) who has completed the Advanced User Training (face-to-face hands-on training, five times a year) to set up the project.
3

When applying for a project, attach a research protocol and CRF file.
4

After approval by the iCReaT manager, the project manager can set up the project, including building an eCRF, and operate it independently.

Join for iCReaT

iCReaT Ver.2

(Studies with scheduled visits)

2

Sharing Platform of Medical and Health Content (SPEC), Korea National Institute of Health
(https://library.nih.go.kr/spec)
Join and training for the version to use

User training for iCReaT ver.2 (mandatory training)

iCReaT system
https://icreat.nih.go.kr

Join > Entering the training system ID or completion number > Approval (text)
iCReaT Lite

(Observational or cross-sectional studies without scheduled visits)

Lite

iCReaT system
https://icreat.nih.go.kr

Join > approval (text)

Sharing Platform of Medical and Health Content (SPEC), Korea National Institute of Health
(https://library.nih.go.kr/spec)

Lite user training available (Non-mandatory training)

Adding project team members

Request made to add team members to the organization responsible for the project > Adding users by the person in charge of managing project team members

Request for additional versions

Enter your previously created ID and password in the login window for the additional version you want to use.

● 수집하는 개인정보의 항목 가. 질병관리청은 임상연구관리시스템의 원활한 운영 및 관리를 위해 최초 사용자가입 당시 아래와 같은 개인정보를 수집하고 있습니다. - 필수항목 : 성명, 소속기관명, 이메일, 휴대전화번호 - 선택항목 : 소속기관부서, 연락처 나. 서비스 이용과정에서 아래와 같은 정보들이 자동으로 생성되어 수집될 수 있습니다. - IP Address, 방문일시, 웹브라우저 종류, OS 종류 ● 개인정보의 수집 및 이용 목적 가. 임상연구관리시스템 서비스 이용 권한 승인 나. 임상연구 및 임상시험 데이터 관리 다. 업무 활용(설문 조사 등) ● 개인정보의 보유 및 이용기간 등록된 개인정보는 원칙적으로 개인정보의 수집 및 이용목적이 달성되면 지체 없이 파기합니다. 단, 다음의 정보에 대해서는 아래의 이유로 명시한 기간 동안 보존합니다. - 사용자 승인 반려 및 승인기간 종료 시 보존 개인정보 ① 보존항목 : 성명, 소속기관명, 이메일, 소속기관부서, 연락처 ② 보존사유 : 반려 사용자의 재가입 방지, 종료 후 서비스 재이용 ③ 보존기간 : 승인 반려일, 승인기간 종료일로부터 1년 ● 권리 원칙적으로 개인정보 보호법에 의해 개인정보 수집 동의를 거부할 권리가 있으며, 수집 동의 거부 시에는 임상연구관리시스템의 이용이 불가합니다.

위의 '개인정보 수집 및 이용에 대한 안내'에 동의 합니다.

● Items of Personal Information Collected (a) The Korea Disease Control and Prevention Agency (KDCA) collects the following personal information at the time of initial user registration for the efficient operation and management of the Clinical Research and Trial Management System (iCReaT). - Required items: Name, Affiliation, Email address, Mobile phone number - Optional items: Department, Office phone number (b) In the course of using the service, the following information may be automatically generated and collected: - IP address, Date and time of visit, Web browser type, OS type ● Purpose of Collecting and Using Personal Information (a) Approval of service usage rights for the Clinical Research and Trial Management System (b) Management of clinical research and clinical trial data (c) Business purposes (such as surveys, etc.) ● Retention and Use Period of Personal Information As a general rule, registered personal information will be destroyed without delay once the purpose of collection and use has been achieved. However, the following information will be retained for the reasons specified below for a certain period: - Personal information of users whose approval has been rejected or whose approval period has expired ① Retained items: Name, Affiliation, Email address, Department, Contact number ② Reason for retention: To prevent re-registration of rejected users and to allow reuse of the service after expiration ③ Retention period: 1 year from the date of rejection or expiration of approval period ● Rights In accordance with the Personal Information Protection Act, users have the right to refuse consent to the collection of personal information. However, refusal to consent will make it impossible to use the Clinical Research and Trial Management System.

I agree to the “Notice on the Collection and Use of Personal Information” above.

Notice on Collection and Use of Personal Information

● Items of Personal Information Collected A. In order to ensure smooth operation and management of the Clinical Research Management System, the Korea Disease Control and Prevention Agency (KDCA) collects the following personal information at the time of initial user registration: - Required items: Name, Affiliated Organization, Email, Mobile Phone Number - Optional items: Department, Contact Number B. During the use of the service, the following information may be automatically generated and collected: - IP Address, Date and Time of Visit, Type of Web Browser, Type of Operating System ● Purpose of Collection and Use of Personal Information A. Authorization for the use of the Clinical Research Management System B. Management of clinical research and clinical trial data C. Administrative use (e.g., surveys) ● Retention and Usage Period of Personal Information In principle, registered personal information is destroyed without delay once the purpose of its collection and use is achieved. However, the following information will be retained for the period specified below for the stated reasons: - Personal information retained after user access is denied or after the authorization period ends ① Items Retained: Name, Affiliated Organization, Email, Department, Contact Number ② Reason for Retention: To prevent re-registration by rejected users, and reuse of services after expiration ③ Retention Period: 1 year from the date of rejection or expiration of authorization ● Rights In principle, under the Personal Information Protection Act, you have the right to refuse consent to the collection of personal information. However, if you refuse consent, you will not be able to use the Clinical Research Management System.

I agree to the 'Guide to Collection and Use of Personal Information' above.

Consent to receive SMS

* Due to the Korea Disease Control and Prevention Agency's security policy, if you lose your password, a temporary password will be sent to the mobile phone number you entered.
Please confirm whether you agree to receive SMS messages and enter your mobile phone number accurately. Before service integration, emails and SMS messages will be sent simultaneously.

ID
Mobile phone number*

SMS reception consent
Password*