Close Out

ICTU Global study teams are experienced in conducting close out visits and study related activities in accordance with the monitoring strategy/plan and other relevant standard operation procedures as outlined in study protocol and clinical trials agreement (CTA). ICTU Global study teams can undertake the following site close out activities as outlined below:

• Recruitment status – confirming that enrolment has been completed or stopped at the site prior to close out
• Participant related documents: eCRF/CRFs that have been completed are checked for completeness
• Query resolution – all outstanding data clarifications and/or queries must be resolved, and data should be frozen
• Follow up:  The site investigator must be aware of any future reporting requirements pertaining to Adverse Events (AE) and Serious Adverse Events (SAE) and the follow-up of ongoing SAEs
• Investigational product (IP) – all IP related documents (accountability logs and forms, shipment logs and forms) must be reviewed and filed appropriately in the Investigator site File (ISF).  A final reconciliation of IP must be done and if there is a discrepancy this should be documented and filed in the ISF.  IP and trial supplies must be returned to the sponsor or destroyed as per protocol. All activities carried out in line with this should be documented
• Randomization code envelopes – if randomization strategy of trial is used, these code envelopes should be collected at close out. All randomization envelopes are accounted for, and the seals have not been broken.  Reasons for any unsealed envelope must be documented.
• Final inventory – A final inventory of remaining or unused trial supplies (including equipment loaned to site like tablets, computers) must be completed.  This should be returned either to sponsors or destroyed in accordance to the sponsor’s requirement and appropriately documented
• Finances – it should be confirmed that there are no outstanding payments related to the trial at site.  All financial documents should also be documented and filed
• Documents – the ISF should be checked to ensure that all essential and required documents have been filed appropriately
• Draft and finalise site’s close out report ensuring that a final copy is sent to sites’ investigators and sponsor.  
• Notify the Ethics Committee(s) of trial completion/termination at site