Keys for a successful closure visit!
You are CRA and you are about to close a center? Know that a closing visit is differently prepared from a monitoring visit. So here are some tips to guide you to a successful closing visit! (Tested and approved:) )
1. Well prepare your visit
Well preparing a closing visit is essential. This will save you time on site, both for you and your investigator team.
- Make sure you have a complete checklist of the investigator and / or pharmacy workbook. Update it regularly during your monitoring visits and collect the documents progressively. Do not underestimate this task, because depending on the study complexity, a workbook can contain several volumes!
- Print the missing documents or those to be signed by the team, bring them back on site during your visit. Similarly for blank forms, just in case (accounting form for the study products, for example).
- You can also anticipate the lack of a document such as the lack of a training certificate of a team member who left the hospital, by preparing a note to file, ready to be signed by the investigator.
- By means of previous monitoring reports and follow-up letters, and also with your updated monitoring tables, create a calendar listing the pending issues (the queries), in order to remind you to solve them with the investigator team.
- To be more effective, inform the investigator in the confirmation letter that you will send him in advance (the week before the visit, by email) the agenda of the visit, the persons that need to be present and the possible latest required documents (thanks to your checklist! CV, documents to be signed, etc…).
- To avoid any surprise, the day before your visit confirm that you are coming to the center, with a simple phone call or email. You must be sure that the principal investigator will be there the day of your visit. If it is not the case, contact your project manager the soonest possible to react accordingly (shift the date of the visit or still visit the site).
- Also mind to ask the center how they wish to save the study documents. Do they need archive boxes? Or do they want to save the documents in the files originally supplied? If they cannot get them, bring some boxes. You can, for example, note on the archives boxes, to be easily found during audit or inspection:
- The name of the study
- A statement as “Do not destroy before XXXX” (end of filing date)
- The investigator and laboratory name
2. During the visit
At the pharmacy:
Make the final accounting treatment of the study and prepare their return or destruction. In case of on site destruction, retrieve the certificates of destruction.
Check and update the workbook. inform the pharmacy team of the place and the duration of study documents conservation. Sometimes the pharmacy keeps the pharmacy workbook and does not want to let it with the investigator workbook.
In the clinical service:
In order to remember everything, make sure to follow the agenda that you have set for yourself: check and validate the latest data and / or queries, then finalize the investigator workbook using your updated checklist. Destroy the extra blank documents (unless the promoter ordered the opposite) and retrieve copies / original of documents for archiving in the promoter.
Well arrange informed consents in the investigator workbook so that they are all centralized in one place and easy to find when needed. Some investigators tend to leave them in the medical patients records.
In case the promoter requests, retrieve eventually loaned equipment to lead the research.
Make sure to remind the investigator his various obligations during the closure : archiving time period for investigator workbook, audits or inspections, articles publication …
Find out about the exact study documents and patient records storage location : on site, or outside of the hospital? Well file this information in your closure report; it can be used in a few years in case of audit or inspection.
3. After the visit
Write the closure report and transmit it to your project manager right away as long as you still have ideas in mind!
Then prepare the closure letter, both for the investigator and for pharmacy, reminding the site the investigator obligations mentioned above: his responsibility in terms of archiving (Article E1123-61 of CSP) the investigator workbook and / or pharmacy and its duration (depending on the type of products studied, see the Decree of 8 November 2006), the scope of audit or inspection of the competent French authorities and / or of another countries in case of international study, conditions of scientific articles publications…
These are what to help you preparing your closing visit. Good luck!
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