임상 및 비임상
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South africa 임상시험 등록
| 작성자 | 관리자 | 카테고리 | |
|---|---|---|---|
| 작성일 | 2014-08-28 | 조회수 | 1,843 |
| 국가정보 | 아시아>대한민국 | ||
| 출처 | sanctr | ||
| 원문 | http://www.sanctr.gov.za/InvestigatorInformation/Howtoregister/tabid/180/Default.aspx | ||
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Every effort must be made to ensure that the data inputted is correct and valid and is in a format that is understandable to the lay person. Particular care must be taken with applications involving multi sites / multi sponsors.
Step 1: The trial information required for the South African National Clinical Trials Register is coordinated through the initial ethics application process. Trialists initially capture trial details on-line at www.ethicsapp.co.za whereafter a proof of capture form is printed and submitted with the ethics application pack to the relevant accredited research ethics committee.
Step 2: Upon receiving written ethics approval from the relevant research ethics committee or Medicines Control Council, your application for a South African National Clinical Trials Register number begins. You apply for your unique trial number via the www.sanctr.gov.za site where you can "Login" using your login details obtained when you registered at www.ethicsapp.co.za. Select the "SANCTR Toolkit" button to enter regulatory authority approval information required to request a SANCTR Number. Step 3: The data is then sent to the Department of Health ‘desk’ where the SANCTR Number is allocated. Receipt of the SANCTR number provides the research team with the authority to commence the study pending all other relevant regulatory clearences have been granted. The SANCTR number will be generated within two (2) working days. This will be done either by email or fax and will be sent to both the relevant research ethics committees and the applicant. Step 4: Those studies that require additional registration with the Medicines Regulatory Authority, after ethical clearance, will be entered onto both the Medicine’s Control Council database and the SA National Clinical Trials Register. Please note, confidentiality related to the regulatory process will be observed. |
