Completion↦Documents↦Required Documents↦Study Closure
What is it? Why is it important?
A study is closed once the last study participant has had the last study visit.
Upon study closure, various activities are implemented, such as:
- Monitoring close-out visit
- Conclusion of IMP management (e.g. accountability, return to SP-INV, destruction)
- Participant safety documentation
- Locking of the study database (CDMS (eCRF)
- Informing the Ethics Committee (EC), as applicable Swissmedic and study participants
- Submitting a clinical (final) study report to EC and if applicable RA
- Exporting data and perform the statistical analysis
- Updating of required registries (e.g. international public registry, federal database)
- Publishing of study results (e.g. scientific publications)
What do I need to do?
As a SP-INV and Site-INV finalize the document management of your study, and prepare documents/records for archiving:
- Date and sign the study CRF (electronic and paper)
- Establish a document filing system that guarantees document identification and traceability. Allows for easy retrieval of documents at some later date.
- Ensure TMF/ISF filing of study relevant essential documents/records and logs (i.e. ensure filing is complete and applicable documents are dated and signed)
- Ensure all study documents/records and study data comply with ALCOAO principles. These principles define that data must be Attributable, Legible, Contemporaneous, Original, and Accurate. Thus, changes must be traceable (dated and signed), and corrected entries must remain identifiable. In eCRFs, an integrated audit trail takes on that task
- In the event study documents / records are copied, ensure compliance with the requirements for “certified copies”
More
ALCOA-O principles state that data must be:
- Attributable - it must be clear to which participant they belong
- Legible - they must be readable
- Contemporaneous - they must be noted immediately after the data is generated
- Original - they must be the original
- Accurate - they must be reliably correct
- Originator information – who entered the data and when
- Thus, changes must be traceable (dated and signed), and corrected entries must remain identifiable.
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
- Appendix C. Essential records for the conduct of a clinical trial