What are the steps for conducting the study?
This section applies to human research with the exception of clinical trials (HRO), to clinical trials (ClinO) and clinical trials with medical devices (ClinO-MD).
For research projects with the exception of clinical trials (HRO):
- Database (in production)
- Participant identification log (coding key)
- Contract if applicable
- Data collection and management
- Collection of consents, if applicable
- Monitoring of serious adverse events (SAE) (only HRO Chap 2)
Close out and archiving
- Database cleaning
- Database locking
- Data archiving for a minimum of 10 years
For clinical trials (ClinO) & clinical trials with medical devices (ClinO-MD):
- Database (in production)
- Monitoring plan
- Data Management Plan (DMP), (if applicable)
- Trial Master File (TMF)
- Investigator Site File (ISF)
- Source Data Location Form (SDLF) signed
- List of delegations and training
- Screening and inclusion list of participants
- Participant identification log (coding key)
- Registration : clinicaltrial.gov & Kofam
- SIV monitoring report signed
- Green light given by the CER (and Swissmedic if applicable) and the monitor
- Data collection and management
- Collection of consents
- Monitoring activities
- Monitoring of adverse events (AE) and serious adverse events (SAE)
Close out and archiving
- Database cleaning
- Database locking
- Close out monitoring visit
- Data archiving (duration depends on the category of the study)
