1. Feasibility
If you are interested in conducting a clinical trial or a medical device clinical investigation at our center, please first contact the Principal Investigator (PI) who will be responsible for leading the study. Once the PI confirms his/her interest, please send the required documentation to trials@ikem.cz.
2. Start-up
To initiate the internal approval process, the complete documentation is required to be sent to trials@ikem.cz, with the PI and/or the clinical trial coordinator cc'ed in the email. We will review your application as soon as all required documentation is received. Incomplete submissions may significantly delay the process. The standard processing time is typically 4–6 weeks; however, this timeframe may be extended depending on the site's current capacity. Documents are processed chronologically in the order they are received. Please submit them well in advance.
In the body of the email, please specify:
- The department/clinic where the study will take place;
- The name of the PI.
Required Documentation:
- Draft contract;
- Draft budget;
- SUKL and/or Ethics Committee approval (CTIS, EUDAMED, RZPRO), or the submission date and expected approval date;
- Insurance certificate;
- Protocol;
- Protocol synopsis in Czech (including a list of all procedures to be performed at IKEM);
- Informed Consent Form (including GDPR information for patients);
- Power of Attorney (if the sponsor is represented by a CRO);
- Certificate of Incorporation / Commercial Register extract (for both the sponsor and the CRO);
- Draft equipment loan agreement (if applicable);
- Other study-related materials;
- GDPR questionnaire.
3. Realization
The clinical trial or a medical device clinical investigation can only start after internal approval and the contract signature by the authorized statutory representative of IKEM.