What is it? Why is it important?
When archiving study documents (e.g. electronic and paper), specific guidelines apply. The aim is to comply with regulatory requirements and to guarantee optimal archiving condition during the entire archiving period.
Guidelines include to:
- Ensure essential document are filed according to specified filing procedures facilitating retrieval at some later date (e.g. master index)
- Establish procedures that guarantee that study information remains legible during the entire archiving period. This includes both electronic, paper, and copied information
- Ensure the multiple backup of electronic documents
- Establish archiving premises with:
- Access control
- Fire protection and fire-safe lockers
- Water damage protection
- Temperature and humidity monitoring to ensure that levels remain within an acceptable range
- Protection against rodent infestation
Even after a study has been archived, the study and its archiving premises can be inspected by regulatory authorities (e.g. Swissmedic).
What do I need to do?
As a SP-INV:
- Define archiving responsibililties
- Pre-approve any archiving procedures defined by the study site (e.g. Site-INV)
- Make sure the Site-INV:
- Knows the required study archiving period
- Is able to guarantee optimal archiving conditions during the entire archiving period
- Uses a tracking system that records any documents retrieved and returned from the archive
- Inform the Site-INV(s) of any upcoming regulatory inspection regarding an archived study and/or archiving premises (e.g. inspection of the study or inspection of archiving premises)
In order to facilitate archiving management, place paper documents and materials in study boxes and clearly label boxes for easy identification (e.g. name of study, SP-INV and Site-INV contact information, date of archiving, indication of content, end date of archiving).
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
ICH GCP E6(R2) – see in particular guidelines
- 4.9.5 Site-INV archiving
- 5.5.7 SP-INV archiving
- 8. Essential documents for the conduct of a clinical trial
ISO 14155 Medical Device – see in particular section (access liable to costs)
- 8.6 Document retention
- Annex E: Essential clinical investigation documents
ClinO – see in particular article
- Art. 38 Notification upon study completion, discontinuation, or interruption
- Art. 45 Data Retention Requirements