What is it? Why is it important?
Upon study end, all data, essential documents and other relevant documents are archived. This is necessary for each single study step to be reconstructed at some later date.
It is required that after study completion / discontinuation / interruption, the study is archived for a predefined period.
The archiving period in Switzerland is at least:
- 10 years for ClinO and ClinO-MD studies
- 15 years for ClinO-MD studies with implantable medical devices
- 30 years for ClinO studies with standardised transplants or studies with blood and blood products (TPA)
- 10 years for HRO studies (by analogy to ClinO studies)
- The EU may extend the storage duration for up to 25 years
For international studies where other laws require longer storage durations, the longest storage duration is decisive.
What do I need to do?
As a SP-INV:
- Check the required storage duration of your study. Retention periods can differ according to study type, involved countries and applicable laws
- In the event of an international study, check international archiving laws and implement the more stringent archiving requirements
- Take the duration of liability coverage into consideration (e.g. set at a minimum of 10 years)
- Inform and train participating Site-INV(s) on the duration and conditions of study archiving requirements
As a Site-INV retain as required after the conclusion or termination of the study:
- All documents needed to identify and provide post-study care to study participants, including potential damage claims
- All other original study data
Where can I get help?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Clinical Trials Unit, CTU, dkf.unibas.ch
Bellinzona, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.ctc.usz.ch
FEDLEX – laws are available online under numbers
- 810.305 ClinO
- 810.306 ClinO-MD
- 812.21 TPA
ClinO– see in particular article
- Art. 45 Data retention requirements
ClinO-MD – see in particular article
- Art. 40 Document retention requirements
TPA – see in particular article
- Art. 40 Obligation to archive