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)

• The UNIGE CODIS [Scientific Information Division Coordination Department] (*) website on research data and University support (http://www.unige.ch/researchdata/)

* by the Open Access and Research Data Division of the Scientific Information Division Coordination Department

• Adaptation of your protocol: contact us via datamanager.crc@hcuge.ch

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 datamanager.crc@hcuge.ch)• secuTrial© validation in clinical trials (request the SOP document UIC.SER.DAT.SOP.02 via datamanager.crc@hcuge.ch)• eCRF validation in secuTrial© (request the SOP document UIC.SER.DAT.SOP.03 via datamanager.crc@hcuge.ch)

Instructions and Responsibilities

• ! Log on to secuTrial© / and by extension REDCapTM (password and responsibilities: French)• ! Connecting to secutrial© / and similarly to REDCapTM (password and responsibilities: English)