Remote Close out visit

• Margaret
  13/03/2019 15:01

  Could you provide me with any advise how to conduct remote close out visit? The sponsor doesn't agree to conduct on site COV, so the remote site closure should be performed. Is any reference guideline how to proceed? Is it allowed to close the sites remotely?
• Anon
  13/03/2019 20:41

  Looks like a Risk Based Approach to monitoring. ICH E6 R2 allows for this (see RQA webcast on E6 R2). Your Risk assessment should state your reasons for selecting different methods of monitoring and close out. You still have to complete all the items needed and also make a report but there is no problem doing it remotely provided that your risk assessment confirms this. Methodology needs thinking about, such as video conference with looking at each document etc or using another person to verify etc.
• Margaret
  14/03/2019 09:28

  Thank you for the reference information.
• FILIPA
  15/12/2020 09:51

  For the remote monitoring/close out visit. Should the CRA request the site to share a temporary folder with the Informed consents and the Subject identification log for verification of the authenticity and if PIS was obtained before the procedures had taken place? as per regulation this documents can only be seen during monitoring visits or audits, and should not be shared. But in the special case where monitoring on site is not possible, showing the documents on camera will not work for comparing the documents and analyze them. So there must be a way for the CRA to have access to this documents to verify its compliance. Or asking this file sharing is not permited
• Anon
  15/12/2020 12:28

  There is lots of guidance relevent to this about the COVID 19 situation. EMA, FDA, MHRA all have guidance about remote visits and how to do them. All worth looking at. In EU they are not happy with remote SDV where sponsors or sponsors agents have remote access to source. You also have to look at each country for how well they tolerate this. EMA guidance is good.
• Juergen Kaetzler
  15/12/2020 17:12

  When no SDV is performed at the COV (which is usually the case if it is not a combined interim-close-out-visit) then a remote close-out should not be a big deal. The risk-based approach and the EMA/MHRA/FDA/... guidances have already been mentioned. >> Just do a pragmatic approach and ask: what would you do at the on-site COV? Then assess how you could do these tasks remotely /on-line. For example reviewing the site delegation/signature log can be done via camera or you ask the site to provide you with this document prior to the visit. Inform the site to provide you with the original or copy (as per your SOPs, but why should sites archive copies?) after the visit. Inform the site on archiving requirements, send the respective labels to the site. >> If you need to close the pharmacy and drug account needs to be finally performed: ask the pharmacy whether they could send you a photo of the remaining IMP (if any) and let them send you the drug accountability logs (before the COV and the final logs after the COV). >> In short: ask what you need prior to the COV, what you will do during the COV remotely and what you need after the COV. >> Remember to document everything as stated in the respective guidances.

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