Completion↦Documents↦Required Documents↦Doument Archiving
What is it? Why is it important?
Upon study termination, all essential and quality documents (e.g. SOPs, WIs, study processes) are archived.
The archive must be set-up in a manner that enables the study to be reteived and retraced at any time during the archiving period.
Archiving processes and premises should be in place to:
- Prevent document destruction before the end of the required archiving period (i.e. protection against fire, excessive humidity, and rodent infestation)
- Ensure premises are access restricted and protected against unlawful access, modification, theft, vandalism and forgery
- Ensure that any removal and retrieval of archived documents is documented and logged
- Allow access and retrieval of documents, should this become necessary (e.g.Ethics Committee (EC) audit, Swissmedic inspection)
Archiving requirements including the required archiving period are defined in the law.
More
After study termination or premature termination, it is required that a study with an Investigational Medicinal Product (IMP) or an Investigational Medical Device (IMD) be retained until the expiry date of the last IMP/IMD batch supplied, or the last series of devices used in the study, but at least for:
- 20 years for IMP and IMD studies
- 15 years for studies with implantable devices
- Or as otherwise specified in the study protocol
Documents required for the identification and follow-up of study participants, including all other original data must be archived for at least:
- 10 years for IMP and IMD studies
- 15 years for studies with implantable devices
- Or as otherwise specified in the study protocol
HRO research projects must be retained after their completion or premature termination for a period of at least:
- 10 years
What do I need to do?
As a SP-INV:
- Define archiving procedures in a SOP., which inlcude risk control-measures to avoid accidental or premature destruction of study documents (e.g. access protected and temperature controlled archiving premises)
- Inform the Site-INV about which documents to archive, including the required archiving period
- Provide an archiving index with an overview of filed documents (e.g. binders are clearly labelled with study name, responsible SP-INV/Site-INV, study site, length of required archiving)
- Ensure validated transfer systems are used when making copies (e.g. certified copies) or when transferring data to another storage medium (e.g. from CD to hard disk)
- Ensure documents are stored in a manner that guarantees legibility over time (electronic and hard copy)
As a Site-INV:
- Follow SOP archiving procedures as provided by the SP-INV
- Designate a staff member responsible to oversee archiving premises, including the correct implementation of the archiving SOP
- Keep a record of archived documents/records in order to request their destruction at the end of the archiving period.
More
tudy documents are archived over many years, which might generate archiving costs. Consequently, when planning your study budget, remember to include archiving costs.
Where can I get help?
Your local Research Support Centre↧ can assist you with experienced staff regarding this topic
Basel, Departement Klinische Forschung (DKF), dkf.unibas.ch
Lugano, Clinical Trials Unit (CTU-EOC), ctueoc.ch
Bern, Department of Clinical Research (DCR), dcr.unibe.ch
Geneva, Clinical Research Center (CRC), crc.hug.ch
Lausanne, Clinical Research Center (CRC), chuv.ch
St. Gallen, Clinical Trials Unit (CTU), h-och.ch
Zürich, Clinical Trials Center (CTC), usz.ch
References
ICH GCP E6(R3) – see in particular guidelines
- Appendix C. Essential records for the conduct of a clinical trial
- C2.4 Archiving of essential records
Swiss Law
ClinO – see in particular article
- Art. 45 Data retention requirements
ClinO-MD – see in particular article
- Art. 40 Document retention requirements
HRO - see in particular article
- Art. 23a Data retention requirements