What is it? Why is it important?
Upon study end, study data and documents (e.g. essential documents) are archived. The aim is to retain the ability to reconstruct the study at some later date.
The required archiving period depends on study type. In Switzerland the minimum archiving period for:
- ClinO and ClinO-MD studies is 10 years
- ClinO-MD studies with implantable medical devices is 15 years
- TPA / ClinO studies with standardised transplants or studies with blood and blood products is 30 years
- HRO research projects is 10 years
- The EU may extend the storage duration for up to 25 years
In the event of an international study having alternative archiving periods, requires that the longest archiving period becomes binding.
What do I need to do?
As a SP-INV:
- Based on your study, define the required archiving period
- In the event of an international study, check international archiving laws and plan for the most stringent archiving period
- Ensure that the study`s liability coverage is taken into consideration (e.g. set at a minimum of 10 years)
- Ensure archiving premises remain acceptable over the planned archiving period (e.g. access control, fire-, humidity-, rodent protection)
- Ensure potential study sites comply with the defined archiving period
As a Site-INV ensure to retain at the study site documents needed for:
- The identification of study participants (e.g. participant identification-log). Post-identification might become necessary in the scope of ongoing participant treatment or potential damage claims
- All other original study data (e.g. source data)
In the event:
- Of leaving the institution, hand over the TMF (SP-INV) / ISF (Site-INV) including archiving responsibilities to a delegated person
- Outsourcing archiving responsibilities, ensure to set up a contract that covers all required archiving aspects
Where can I get help?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, 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.usz.ch
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
FADP - see in particular
- Art. 5d data processing