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This section provides answers to questions asked during the Division of AIDS (DAIDS) Remote Monitoring Discussion session on April, 20 2020. Additional information from the session, including a full recording and slides, are available on the DAIDS Resources and Announcements page under DAIDS Presentations.

Please email ocsomob@niaid.nih.gov if you have additional questions about DAIDS remote monitoring.

Document Transmission

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If the monitor requests the site to send them documents related to protocol implementation (ex. screening and enrollment logs), what should sites consider when transmitting these documents to the monitor electronically?

The site should ensure there are no participant identifiers on any of the documents sent.

Do documents sent to monitors need to be certified as true copy?

No, they do not need to be certified copies, as they are not source documents.

Is it possible to conduct remote monitoring visits by utilizing screen sharing (ex. Microsoft Teams) rather than sending documents ahead of time via email?

Our site's research compliance department prefers that we virtually share documents in this manner for remote monitoring visits. Yes, this is acceptable and a great suggestion. Please be aware that the call may take longer. 

Can sites use file sharing platforms (ex. Dropbox) to share required information with the monitor?

We are looking into some options for file sharing; however, due to security concerns at this time we only have Microsoft Teams that could be a possibility for that. Kindly check with your monitor. 

Lockdown Constraints and Limitations

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What should sites do if an IRB is affected by lockdown regulations?

Check with your IRB – they may be meeting virtually or there may be exceptions for the use of expedited reviews temporarily. Document all efforts. Also check with your PO to determine next steps. 

What should sites do when the requested document cannot be provided to the monitor due to lockdown? Can these documents be provided to monitors when the lockdown eases?

If there are no staff at the site who can provide the documents, the monitor will continue with the remote visit using the documents available in Protocol Registration and will indicate that in the report. The monitor will then follow-up when restrictions are lifted, and the onsite visit can occur.  

Our delegation logs are paper copies. How do we deal with being unable to collect signatures while we are working from home?

The monitor can review the log without the signatures and make a note in the report to follow-up when onsite visit resumes.

Monitoring Scope

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Can sites opt out of the remote monitoring?

If the site cannot participate in the remote review process, the site should provide a reason which will be documented. 

The monitoring process will continue with the remote review of documents available in Protocol Registration and CRF review in the EDC system (Ex. Medidata, OpenClinica).  The visit report will be released within the usual timeframe and will include the reason the site was unable to participate in the remote visit process.  

Do these guidelines apply to WESTAT monitoring for NICHD sites as well?

No, WESTAT is a separate entity. We recommend that you contact WESTAT for guidance on their monitoring approach during COVID-19 pandemic.

Will monitors review IRB approval documents in the NIAID CRMS Protocol Registration System since IRB approval documents are in the Investigator Site Files?

Yes, monitors will be reviewing essential documents in the N-CRMS Protocol Registration system; therefore, it is important to ensure those files are current.

Financial disclosure logs are not currently being sent to PRO. Is this going to be a new requirement?

No, we do not intend to change any PRO process and will not require that you send Financial Disclosures to PRO.

In the current monitoring system, unannounced PIDs are also reviewed. Will this practice continue under remote monitoring?

Yes, we will continue with that practice by reviewing the eCRF in the EDC of any PID.

Can you clarify what is covered in the monitoring of ICF logs? What are monitors looking for?

Monitors would be looking for ICF versions and dates signed, both initial and subsequent consents.  The purpose is for logic checks against CRFs. Not all sites maintain ICF logs, but if your site does, it would greatly assist with the remote data reviews.

For international protocol specific/new sites, will there be special requirements for the first monitoring visit?

We expect that the approach being taken by site personnel and monitors will be similar to the ones taken for domestic remote monitoring.  We assume that the challenges regarding availability of site staff, guidance by local regulatory entities due to COVID 19 will be similar.  

Monitoring Process

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Will remote monitors need to access EHRs/EMRs?

No access will be required at this time; no source documents will be reviewed.

How will monitors identify discrepant data and entry errors without access to source documents?

An example would be if the participant’s year of birth is noted to be 1995 on an entry eCRF, but a lab CRF indicates the participant’s age as 45. 

Where the EDC does not indicate the time informed consent was signed, how will the monitor verify that consent was signed prior to performing procedures?

If the time is not indicated, we would only be able to use the dates on eCRFs and Lab results.

The PVL will state the dates of the monitoring visit but the site needs to send the requested documents in advance for review. Which date (the date the documents are sent vs. the dates of the visit) should we use to record the monitoring activity?

The monitoring activity should be indicated as the date range of the first review call and the debriefing call with the CRS Leader.

Example: The initial call with study coordinator is 4/21 and debriefing call with the CRS Leader is 4/22. Visit would be documented as 4/21-22/2020.  The two calls may also happen on the same date.  

Will the monitoring reports be sent to the DAIDS program officer before verification with source documents?

Yes, the site and the program officer will receive the report at the same time.  However, all findings will be reported as “Other” observations until the monitor has completed an onsite verification of the data.  

What is the length of time for the remote monitoring visit?

The calls can range from 30 minutes to a maximum of 2 hours. This is dependent upon how complete the pre-visit preparation is and how many findings there are to cover. 

Regarding notification of IRBs/regulators about research practices, is there a standard document from the Sponsor sites can use to address remote monitoring due to the pandemic?

Please provide the DAIDS Memo​ dated on April 6th, 2020 to your IRB.

Pharmacy

For pharmacy assessments, does the Pharmacist of Record need to scan all scripts and IP logs to the monitor for remote monitoring?

No Accountability logs or scripts should be requested or sent; only temperature logs will be requested.

Situational

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Is the site required to have any procedures in place for the monitor to verify that the Pharmacist of Record is alone when receiving the study product related call (with consideration of potential for unblinding)?

No, the monitor will request a separate call with the Pharmacist of Record.

What should I do if I have an upcoming continuing review expiration and the IRB approval letter has not been signed yet?

Document the situation and discuss with your PO.

Our last monitoring visit was aborted mid-way, so the assignment was not completed. Do we need a note to file to explain this?

The situation should be indicated within the Site Monitoring Report which should be sufficient. If it is not mentioned in the report, please discuss with your PO. 

Long-Term Impacts

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How will site monitoring reports affect performance evaluation reports during this time?

We don’t anticipate that remote monitoring SMRs will impact performance evaluation. 

Our next monitoring visit is scheduled for late June/early July 2020. Will remote monitoring still be applicable then?

At this time, it is unclear how long the restrictions will be in place.