| Close-Out Visit (COV) | Close-Out Visit (COV) |
| Generally, once the conduct of a clinical trial ends, close-out visits (COV) at the participating investigational sites will take place. A COV is the last visit within a study conducted by the clinical research associate at the investigational site. During the COV, all documents are prepared for archiving which is then performed by the investigational site: all tracking logs used during the trial must be fully completed, signed by the investigator and filed in the investigator site file (ISF). The CRA will also check whether all other essential documents are available in the ISF (e.g. signed informed consent forms, protocol acknowledgements, registration and deregistration confirmations of higher federal authorities, ethics committees or other competent authorities). Any leftover IMP will be returned to the sponsor or destroyed on-site (a destruction protocol and certificate is issued). In general, any study materials still available at site (e.g. laboratory kits, patient diaries, patient questionnaires) will also be returned to the sponsor.
After completion of the COV, the sponsor will receive a detailed report and the investigational site will receive a follow-up letter informing them once more about their archiving obligations and listing all pending issues. |
Deutsche Erklärung |
