Take 5 Training
This month, we want to share with you a new worksheet that study teams would need to complete if using a mobile medical app.
How this is going to affect me as a reviewer?
If the study you are reviewing is using a mobile app, you should be aware of FDA and Emory requirements if applicable.
- FDA: mobile apps (software programs that run on smartphones and other mobile communication devices) are considered “mobile medical apps” if they are intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease (FDA website).
- If the mobile app is considered a “mobile medical app”, the FDA may require an IDE submission. This will occur only if the app is intended to be used as an accessory to a regulated medical device, or transform a mobile platform into a regulated medical device. For example, an app that controls a ventilator or an app that has an attachment that allows the read of glucose strips. Both apps would be considered accessory to a regulated medical device and they should be submitted to the FDA. For more examples, check this page from the FDA website.
- In other cases, the FDA intends to exercise enforcement discretion if the mobile medical app poses minimal risk to patients and consumers. For example, an app who help patients to self-manage their disease or condition. For a more detailed list, please check this link from the FDA website.
- Emory requirements if using IIHI or ePHI use: If the study is capturing individually identifiable health information (IIHI), ePHI or sensitive information via the app, the security group at Emory IT (LITS) is in charge to review the use. If you notice that the app in question is storing this type of information, look for an email, comment, or any other information indicating that LITS already reviewed this use. If you cannot find it, contact your study facilitator or study analyst.
October’s take 5 will focus on medical devices used in human subjects’ research. Team Q has worked on the following documents, that are now available under the members section (reviewer toolkit) in our website:
Additional FDA Guidance:
- Emory IRB Medical Device Guidance- New
- Emory IRB Decision chart for Devices used in Human Subject Research Studies- New
Please, read these documents and let us know if you have any questions. During our take 5 discussion, we will only review the decision chart.
November’s take 5 is focused on the safety events you should be expecting to see at continuing review. Our staff is trained in checking the events and making sure are appropriate for continuing review, but in case of an error, you should know when to ask for events to be removed and managed by the Q team.
Here are the events you should receive in the way of a summary:
- Internal, serious adverse events that were expected (anticipated) and related to subjects’ as participation in the study. For example, if dizziness was expected after taking drug A, the study team would add these events explaining they were related and expected to subjects’ participation to the research
- Internal deaths that were not related to the research. Internal, related deaths should be reported with a reportable event submission and managed by Team Q.
- Unanticipated problems that were already reported during the year. If the team said they did not report, ask the study analyst to send to Team Q for further review
- External events that are similar to the bullets above, only when the external site is under our IRB oversight or under the oversight of a sponsor investigator.
You should not receive at continuing review:
- Safety letters with specific patient information. Those should be reviewed by Team Q
- Monitor reports (those are reviewed by CTAC)
- Any information, not reportable to the IRB, that was sent because the team wants an acknowledgment. Those are also managed via a reportable event or amendment (as appropriate), outside the continuing review.
See in this link, an example of the summary you should see at continuing review. During the meeting, we will review this summary, and our facilitators will give you some examples to discuss.
For our take 5 this month we want to cover the differences between safety monitoring and site monitoring. During out monthly full board meetings, we cover those items when we fill out the omnibus form for new studies:
6) When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
The Data and Safety Monitoring Plan includes:
The site monitoring part of the DSM Plan includes:
The DSM Plan requires the following revisions:
Or ☐ this study poses no more than minimal risk and has provisions to protect the privacy of subjects and confidentiality of the study data.
When we refer to safety monitoring, under the data and safety monitoring plan (DSMP), we are looking for all the measures the study team will take to protect subjects’ safety. For example, details about the involvement of DSMBs to check on concerning SAE patterns, the stopping rules the study has detailed in their protocol, test or procedures done to verify subjects’ safety, etc.
For the site monitoring, we are looking for the monitor or self-monitor part of a DSMP. Depending on study risk, studies may require a person to check the reliability of the collected data, for safety and data integrity. If the study does not have a monitor, as part of a sponsor’s CRO, the study should have a self-audit plan, when someone from the study does the type of monitoring a CRO monitor would do. We have a self-monitoring tool at our website at http://www.ctac.emory.edu/clinical_trial_resources/eu_self_monitoring_tool.doc.
Here is some additional information from the FDA about this:
- Establishment and Operation of Clinical Trial Data Monitoring Committees
- Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring
- Power point from FDA explaining above guidance: Oversight of Clinical Investigations: A RiskBased Approach to Monitoring (Draft Guidance)
This month take 5 will discuss the differences between pending vs. defer decisions at full board. For this, we will be reviewing the attached form. You are doing a good job on that front, but it is never a bad idea to reiterate when it is appropriate to defer a study vs. pending it. In general, if the board has to ask how they are planning to fulfill the approval criteria, vs, being able to tell them what they need to do, the study could be defer vs. pending. For example:
Informed Consent Process
- Clarifying the timing and circumstances under which the informed consent of prospective subjects will be sought (OHRP notes that in this example the IRB would need the investigator’s response to make the determinations under 45 CFR 46.111(a)(4); see example 2 below for an alternative approach that would allow the IRB to approve the research with conditions).
Example 2: For a randomized clinical trial comparing two types of surgical procedures, requiring that the investigator – in order to ensure that informed consent will be obtained under circumstances that provide prospective subjects with sufficient opportunity to consider whether or not to participate – revise the protocol to indicate that informed consent of the prospective subjects will be sought by the investigator during an outpatient clinic visit at least one week before the surgery, and designating an IRB administrator or other qualified IRB staff member to review the revised protocol and verify that the requested language regarding the process for soliciting informed consent of the prospective subjects was added to the protocol.
Using this example idea, if the study team is proposing a study conducted in the OR in trauma patients who are taken directly to the OR but they did not provide clear information of how the consent will be obtained, then the study may need to be deferred. If the board can tell the team to consent the LAR or there are other justifications to allow variations in the consent process (maybe the surgery is standard of care, but the research part is only obtaining samples from discarded tissue), then it could be pended.
There probably are better examples than this one, and we used the ones provided by OHRP, so this is always a form we can improve. Let us know what you think during the meeting or via email.
Welcome to September! Looking forward to fall weather and all that it comes with it! The take 5 for this month is where to find important information that is reviewed during continuing reviews. We want to show you how useful it is to use the CR/RE/AM/Close out tab and what information you should be collecting from it.
To review this tab, go to a study you are reviewing and click on the AM-CR-RE-Close out tab:
After clicking in it, you will be able to see past continuing reviews and amendments:
As part of the continuing review process, it is very important to verify if an amendment may have changed the risk level of a study, or if the information reported about serious adverse events and unanticipated problems matches the continuing review submission.