Completion↦Quality and Risk↦Archiving↦Study Records
Was betrifft es? Warum ist das wichtig?
Upon study termination all essential and other relevant quality documents are archived. This is essential to reconstruct the study at some later date.
To retain access to archived documents is the only reliable mean to verify that:
- The information and results described in the Clinical Study Report (CSR) and applicable publications are correct
- The SP-INV, Site-INV, including relevant study staff did conduct the study in compliance with the Ethics Committee (EC) approved study protocol, ICH GCP, applicable regulatory requirements (e.g. Swissmedic, FOPH, international), and the law (e.g. Swiss law)
Note: Retention periods vary between ICH GCP, European regulations, and national laws. When conflicting requirements exist, the longest retention period will apply.
Mehr
In Switzerland the required archiving periods are for:
The SP-INV:
- Clinical trials with Medicinal Products (including organ/tissue/cell transplantation and other clinical trials):
- Until the expiry date of the last delivered batch but at least 20 years after trial completion/termination
- Clinical investigations with Medical Devices and in Vitro Diagnostic Devices (IVD):
- Until the expiry date of the last manufactured device/series but at least 10 years after completion/termination
- Implantable medical devices: At least 15 years after completion/termination
The Site-INV:
- Clinical trials with Medicinal Products (including transplantation studies and other clinical trials):
- At least 20 years after completion/termination
- Blood/blood product transplant trials: At least 30 years after completion/ discontinuation
- Clinical investigations with Medical Devices or IVD studies:
- At least 10 years after completion/termination
Implantable Medical Devices: At least 15 years after completion/termination.
Was muss ich befolgen?
A a SP-INV:
- Ensure appropriate archiving facilities for both short and long-term archiving
- Make a list of documents to be archived. Establish an archiving index for ease of retrieval at some later date
- Define documents that must remain archived at participating study sites (e.g. participant identification logs)
- Write an archiving SOP
- Ensure study sites comply with the SOP and the required archiving period
- Notify the study site when records are no longer needed. Include required destruction procedures (e.g. destruction certificate)
As a SP-INV and Site-INV ensure that during the entire archiving period:
- Documents (electronic and hard/paper copies) remain legible.
- Document transfers to another medium are validated (e.g. certified copies)
- Only authorised personnel retain access to the archive
- The removal and retrieval of archived documents is recorded
- Premises are protected against fire, humidity and rodent infestation
In the event of an audit or inspection ensure archived documents are made readily available upon request.
Wo kann ich Hilfe anfordern?
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(R2) – see in particular guidelines
- 5.5 Trial management, data handling, and record keeping
- 5.5.6 Data retention
Swiss Law
ClinO – see in particular article
- Art, 18 Storage of data and biological material
- Art. 45 Data retention
ClinO-MD – see in particular
- Art. 40 Data retention requirements
HRO – see in particular article
- Art. 5 Storage of data and biological material
Transpantation Act (TPA) – see in particular article
- Art. 35 Mandatory archiving