11/03/2020
With no end in sight, sponsor/CRO monitors continue to look for guidance on best practices and logistics for remote monitoring during the pandemic. Our Clinical Leader article “Remote Monitoring In The Wake Of COVID-19 — Practical & Regulatory Considerations” has inspired related questions. Here is a sample of a recent one.
Many sites now use eReg vendors such as Veeva, Florence, RealTime, etc. as a source document depository database for monitors to review and leave source questions within. This allows the monitors to conduct SDV on certified source remotely.
Question 1: But what about life before COVID and visits that occurred before? How do monitors verify that source questions (i.e., sticky notes on the binder left at a previous monitoring onsite visit) are addressed? How do you go about confirming the source is finished being monitored?
Answer:
Any paper sticky notes that were left on binders pre-COVID would likely need to be managed with a video conference approach or another way like re-monitoring. Unfortunately, you may not be able to address the sticky notes otherwise depending on the monitors’ process.
In general, paper sticky notes left during a monitoring visit is not a good practice anyway. They do not have traceability (part of ALCOA+ quality documentation practices). There are many other issues with uses of sticky notes for more than a flag. Definitely it should not be used for writing questions left at the site. This reinforces the best practice of leaving a site visit assuming you may not be back.
Question 2: With collaboration software, some sponsors are having monitors leave questions about the source in the system, and sometimes the site answers that they clarified the source or added source, but the sites are not uploading the updates to review. How should this be managed when sites refuse to upload additional source or do not do so timely?
Answer:
Due to the inability to monitor onsite, monitors are sometimes using collaboration software within the document repositories that allow an external party to add a comment on a source document. This software is becoming more accessible and is designed to support the remote process of sticky notes. These electronic sticky notes do not fall off, but can introduce new risks, similar to paper stickies or the monitor’s eCRF queries.
These eSystem stickies should have an audit trail and not be tossed away. It is important that the monitor does not write them to request changes in source. They should be used as a tool that can ask questions about source or complement a call or meeting with the site to resolve discrepancies or questions about source. They should not be used for all questions or overused as a substitute to speak with the site team. It is very laborious for a monitor to write out the number of questions they may have.
Also, review of the source is dynamic and often questions get answered as you review, or the content of the question might be more related to the site’s source documentation process and not something a monitor should place as a sticky note. It may be better to make a communication plan with the sites that they will agree to, like at the onsite visit. This will decrease the burden on both the monitor and site. This may make the question on how to get a site to re-deposit scanned source not necessary, except for a few circumstances. There is a big risk that this feature lends to decreased communication that can support relationships, critical thinking, and analysis of issues.
Another thing to consider is that if the source is temporarily stored in these repositories and then deleted, then what happens to the stickies? What if the deletion date comes and the stickies are still on the source? A delay in destruction? Does the audit trail of the stickies still stay and does that mean the source is not destroyed? Source is for the site to create and control, not sponsors. If the repository is at the sites and not the sponsor, this may be still an issue if the repository is not permanent. Remember, this is not data collected and maintained by the sponsor. Keep it simple and do not create extra steps for monitors to focus on the minutiae rather than what matters.
Source documentation should not be changed to match the eCRF. If there is a discrepancy, the appropriate (qualified) site personnel can clarify a discrepancy in the source, maintaining the original source and real time dating the clarification. This is the same when there are discrepancies between two sources. Maintaining the original source is essential. So, monitoring that the answer to the important source query is supported is what is important, not changing the source. I would push back also as a site. Many of the systems are offered by the sponsor and not by the site. No matter, decide if it is necessary for the site to upload everything, versus source linked to critical data, or to screen share visits where there is less source, like verifying what AEs may have occurred since the last visit. Maybe a conversation on the phone or video call is needed.
Stay tuned for Part 2 (of 2) of the blog to learn more about best practices for remote monitoring of any eSource questions left for the site.
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Read our related Clinical Leader article, “Safeguarding Participant Data During Risk-based Monitoring — Practical Considerations.”
You may be interested in our recorded webinars:
1. ‘Remote Monitoring Operations and Maintaining HIPAA, GCP, and COVID-19 Restrictions’ including a helpful Q&A reference free with purchase.
The focus is on the sponsor/CRO’s perspective. Purchase by clicking here.
2. ‘A Case for Sponsor Monitoring Remote Access to a Site’s EMR!’
The focus is on the site’s perspective. Purchase by clicking here.
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