Support for clinical studies and research projects

From a research question to a scientific publication: We offer partnerships by supporting clinical studies and research projects of all kinds.

Icon_Consulting

Our consulting services
 

Whether you are conducting a drug, medical device or other clinical trial, a cohort study or research with routine data: Together we find out in which areas we can best support you.

  • We provide advice, directly
    and free-of-charge.


     
  • We arrange and coordinate
    all Scientific Services.
Icon Tips & Help

Tips & support

 

For concept creation 
Systematic literature searchMore information
Free statistics consultationMore information
Refresh your statistical knowledgeTo the references
Recruitment of study participantsMore information
Integration of Patient % Publiv Involvement measuresMore information
Funding application at the SNSF programme "IICT"More information
(German only)

 

To obtain approval 
Determining the study/project category according to the Human Research Act (HFG)Access the categoriser
Submission of the application to the ethics committeeAccess guideline

 

Around your research data 
Create your own REDCap® databaseMore information
Importing data from secuTrial® into RMore information
Data transfer to the DKFFor instructions

 

For study preparation 
Training for new Study Nurses at the USBArrange appointment
Templates for forms, checklists, logs, etc.Request access
SOP templatesRequest access

 

During study conduct 
Adverse event reportingAccess info sheets
Study inclusion of children, adolescents or persons in emergency situationsAccess info sheets
Consent of persons providing their data and samplesAccess info sheet

 

SCTO platforms

Tools & Resources

Tools and information resources for academic clinical research compiled by the national platforms of the Swiss Clinical Trial Organisation (SCTO)

More information

Icon_Free

Free-of-charge for DKF research groups

(requires prior clarification)

Data Analysis/Statistics
Statistics consultation
Sample size calculation and feasibility check

 

Data Management
Validated RedCap® instance for own development of a study database

 

Data Science
Consultation hour for technical questions on data preparation and visualisation, R and RShiny programming

 

Monitoring
Monitoring plans for category A studies

 

Outpatient Study Centre
Use of faciliies and infrastructure

 

Patient & Public Involvement

Support in writing PPI plans and implementing PPI measures

Support in implementing PPI measures

 

Project Management
Support and Management of Data Safety Monitoring Boards
Support for submission of funding applications

 

Quality Affairs
Consulting on quality management systems (QMS)
Use of the QMS tool Orca
Support during audits & inspections, incl. preparation of CAPA plan

 

Regulatory Affairs
Regulatory review of study documents
Initial submission to ethics committee and authorities
Submission of amendments (after prior evaluation)
Support and Management of Data Transfer & Use Agreements
Study registration (applies to all studies at USB)