Procedures and Manuals for Investigators
The sponsor and/or investigator will meet with our team to discuss their protocol and potential possibilities that best meet their needs and the organisation of their study. Various services will be offered, keeping the available budget in mind. Please note that the best time to complete this planning step is before the study protocol is finalised and submitted to the Ethics Committee.
Among other possibilities, the investigator will be able to participate in developing the eCRF--a relatively simple task using secuTrial© and REDCapTM—and in free training coursesregularly offered by our Centre (see course schedule).
Submissions to the Swiss National Science Foundation (SNSF) and Ethics Committees (ECs)
• CRC/UIC template for the Data Management Plan: (Data Management Plan (DMP) for clinical research projects - English), to be adapted by the investigator
• SNSF Data Management Plan - Guidelines for Researchers (DMP Guidelines).• SNSF FAIR Data Repositories - Explanation (FAIR Data Repositories Explanation)• SNSF FAIR Data Repositories - Examples (FAIR Data Repositories Examples)
* by the Open Access and Research Data Division of the Scientific Information Division Coordination Department
• Adaptation of your protocol: contact us via firstname.lastname@example.org
SOPs and Information for Sponsors and Principal Investigators(access limited to the HUG network)
• Using secuTrial© in clinical trials (request the SOP document UIC.SER.DAT.SOP.01 via email@example.com)• secuTrial© validation in clinical trials (request the SOP document UIC.SER.DAT.SOP.02 via firstname.lastname@example.org)• eCRF validation in secuTrial© (request the SOP document UIC.SER.DAT.SOP.03 via email@example.com)
Instructions and Responsibilities
Guides and Manuals (for Investigators and Monitors)
• REDCapTM: Training Resources
• English secuTrial©: Guide for Investigators and Monitors
• French secuTrial©: Guide pour Investigateurs et Moniteurs