Clinical Trials Unit Frequently Asked Questions
COVID-19 and Clinical Trials
You can let the IRB know during a Continuing Review application/process, and just do a note to file for your records explaining that you are holding enrollment and will submit an Amendment if you decide to change visits to be remote.
From the experience that we’ve had so far, the PI or Sub-Investigator has and will obtain consent from the infected patients or their quarantined LARs. We do not want our Clinical Research Coordinators or Study Coordinators to interact with infected (or possibly infected) patients.
Answer A: Yes, we are not taking the original consents back from the patients or LARs. In our consenting experience so far the PI has taken a photo of the signed ICF. The file of the ICF photo is the study record of the consent document. The IRB has given us indication that they would accept just a photo of the signature page(s) of the ICF - as long as the version date or version number is visible on that page - so the PI doesn't need to take a photo of all ICF pages.
If the patient cannot consent (e.g. is intubated) and the LAR is in quarantine, our plan is to conduct consent process via phone, then provide a copy of the consent form (paper or scanned & emailed) already signed by the person obtaining consent. The LAR can then take a photo of the ICF signature page after they also sign and we'd have a copy with both signatures.
Answer B: In our experience, to avoid having PHI on personal phones, some of us were using a study ipad to take a snapshot of the signature page. That requires our study team to bring the iPad to the floor. Our coordinators are going to the MICU to consent, but do not physically go into the room. We have not always had a clear glass window, but the nurse has held up the ICF in the door of the room.
We haven’t seen any written restrictions on research staff in the U Hospital or Clinics with COVID patients, but there might have been something on the Hospital side that hasn't been posted on the VPR website. However, even without formal restrictions, we think this wouldn't be a good idea. We think that only faculty & staff with proper education and training should be in potentially infectious areas.
Please email the admin and they should respond. In the previous mass IRB email update they've stated that their staff will be unable to answer direct phone calls while working remotely (which they all are currently), so don't hesitate to email.
Please make sure you request 2 waivers in this case: 1) A waiver of documentation of consent and 2) if you don’t want to collect a signature (which is a required element of authorization), also please request an alteration of authorization in order to waive the signature portion.
As for the consent form, a Consent Cover letter format may be too short, please use the full/regular consent form, but without the signature (remove the signature block).
Since the blood draw is required in this study for the biorespository you don’t need to do anything else.
However, if it was optional and you had boxes to check (Yes/No), you may have found the following info. from the IRB useful: 'Research visits that cannot be performed remotely and are not essential to a participant’s health and/or well-being should be postponed or conducted outside University Hospital and Clinics facilities in research compliant space. For necessary in-person visits we encourage visits to be relocated from University Hospitals and Clinics to research compliant space on campus. Please contact Nurse Manager Michelle Adams if you need assistance relocating your study activities from a clinical area of the UU Hospitals and Clinics to the Clinical Services Core of the CCTS, 421 Wakara. If you have questions about clinical research, please contact the CCTS at Dixie.Thompson@hsc.utah.edu. IRB staff can refer study teams to CCTS.'
Research teams don’t need to change everything to being remote, for example, don’t change your consent process to only being remote – but add a remote consenting plan during the COVID emergency/quarantine. Since we don’t know when it’s going to end there isn’t a specific timeframe to include. This is also to avoid having to do another amendment once this is over, so the study team can just revert back to the original protocol.
As it impacts the protocol visits themselves, the IRB needs to know what visits/procedures may take place at home during COVID and what visits/procedures still have to happen at the hospital, or what procedures will happen at the hospital because the participant is already there for clinical care. Study teams should also say that this will just be during the times where people can’t come in, etc. So, this doesn’t have to be as detailed as a chart of which visits will happen where, per se, but the IRB has to know what kinds of procedures will happen at home and what kinds of procedures will happen at a visit because they need to make sure that things that are happening at home are OK to happen at home and that you have a protocol in place to handle those things to ensure safety and compliance.
B: From the IRB side, it is difficult to make determinations about risk without knowing on how procedures will be performed on a study-specific basis. Therefore the IRB prefers less generalized statements such as, “Appropriate appointments will be moved to telehealth”. This doesn’t fully explain what “appropriate” means in the context of the study. The IRB doesn’t need each visit laid out in point by point detail, but if the study team can say something like, “These are the upcoming types of procedures that can be done via telehealth” and “These are the upcoming types of procedures that will have to be delayed because they can only be done in person (because of risks, logistics, etc.),” then the IRB has an idea of what is appropriate.
The IRB understands that everyone has a lot on their plates and cannot submit amendments as quickly as possible in response to the pandemic, this is why the IRB is going to be understanding about deviations that occur. But as the study team gets bits of time to submit amendments, the IRB would like to see them come to avoid long term deviating.
Please refer to the PULSE COVID-19 web page for ongoing guidance from U of U leadership and from groups like the IRB and OSP. The IRB guidance/updates includes good information on obtaining consent (including e-consent process) from patients/LARs in isolation.
There are various options for Remote Monitoring (including uBOX, EpicLink, Zoom and more). Please click the following link to see a detailed summary of methods our IM research teams can utilize:
Institutional Review Board (IRB)
There is no need to list ALL the changes! Do NOT simply copy/paste everything the sponsor has provided, like the Summary of Changes. Please summarize and list the most important and applicable changes (this still may be a fairly long description depending on what has changed and the context). Please feel free to break down the changes (i.e. Changes to IB, changes to protocol) and don't list all the details. Since the listed changes will also be updated by you in the main study application (via Update study) if it affects the content listed there.
NOTE: Please don't forget to refer to the IRB Review Tips document found on Pulse. It provides guidance on how the IRB applications should be filled out.
Tips:
- Give AMs clear titles, be concise and clear in the description section
- Group similar changes together, break down the changes
- Make sure to use ‘Update Study’ to update the study application and attach any updated/new documents
- When attaching any revised documents, please attach a copy with the changes tracked (and name the document accordingly). Attach a clean copy of the revised document too.
- Always ask the Sponsor for Summary of Changes, and Tracked versions of any updated documents (Protocol, IB, consent, surveys etc.)
No. You must either use a recruitment letter or email. The sample text must be approved by the IRB, and the process must be described in the ERICA application.
Yes. But you must explain the details (lack of wet signature, and different dates of signatures between you and the patient, etc.) in the Documentation of Consent document. Then make a copy of the signed document and send it back to the subject to keep as well.
IRB response: Short answer, it depends. Nothing can be decided until a Reliance Consultation is held with the IRB. So request that as a first step! There are too many factors that go into making the decision to allow reliance on an external SIRB or to allow Utah to be the SIRB.
Please visit the ERICA ACCESS INSTRUCTIONS page. If he or she is a U of U employee or student and have already registered for a University account, have her login to ERICA. She'll be able to access ERICA with her campus uNID (The ERICA system synchronizes its login information with CIS). To create the account go to the ERICA login page (login is the uNID, and password is same as for CIS).
Once logged in, the system will recognize that he or she is logging in for the first time prompting them to fill out the "Self-Registration Page." Upon completion of the Self-Registration page, they will be asked to log in again. This time, it will direct them into ERICA. After he or she registers, you'll be able to find them in the ERICA system and add them.
Yes, but only if you don’t have any outstanding (in progress) applications (CRs or AMs), and ONLY the PI can submit such a change using the ‘Edit Personnel’ button.
The Edit Personnel activity is a mechanism for changing the study contacts, internal staff and Sub-Is, and guests without an amendment application. Changes that can be made include adding personnel, removing personnel, and indicating which internal staff and sub-investigators are responsible for obtaining informed consent.
*Changing the PI DOES require an amendment.
For more details and instructions please visit the IRB's Editing Study Personnel page.
- DOES apply to studies that are subject to rules and regulations of the Common Rule Agencies
- DOES apply to studies approved by the IRB on or after Jan 21, 2019
- DOES NOT apply to FDA-regulated research
- DOES NOT apply to non-federal research, including research NOT conducted/supported by a Federal department or agency
Yes, all consent documents must be stamped by the IRB in order to be considered approved. Word Documents must include the watermark in the footer that the IRB has used for many years. IF you’d like to upload your consent as an Adobe PDF Document: ERICA can stamp it with an approval stamp image. But you must leave enough space at the bottom of the document so the image can be placed correctly. The IRB watermark footer page will still be available on the Forms & Templates menu.
No. The IRB convenes once per week (convened board meeting) and is comprised of seven (7) panels, with about 18-20 members per panel:
- Panel 1 - First Wednesday of the month
- Panel 2 - Second Wednesday of the month
- Panel 3 - Third Wednesday of the month
- Panel 4 - Fourth Wednesday of the month
- Panel 5 - Does not meet every month
- Panel 6 – Third Thursday of the month
- (Panel 7) – This panel does NOT convene, but handles Expedited reviews electronically
Meetings (full board) are from 12:00 pm - 3:00 PM. Each convened meeting agenda includes a mix of New Study applications, Amendment applications, Report Forms, and Continuing Review applications.
Total time from submission of a new application to approval can take from 4-6 weeks, but this timeline is not guaranteed. Furthermore, the Initial review time (goal!) for any type of application is 2 weeks from submission (aka reviewers request any revisions). After the revisions are completed and re-submitted by the study team, the time frame for the IRB to complete/tend to those revisions is not defined. If you haven’t heard back within a week or so, call/email the reviewer (can be found under the Correspondence tab in ERICA).
There is no written policy for this on the IRB website, but there is an internal agreement among the IRB staff, and it is as follows:
There are 2 options for the inclusion/use of the pregnant partner consent doc.
1. If you strongly anticipate its use, and would like to include it with your application please do the following:
- In order to allow the follow-up of a pregnant partner consent, the ERICA application must have the vulnerable population of Pregnant Women & Fetuses selected and justification for the follow-up procedures described. To add this vulnerable population, please navigate to page Participants #3 to indicate that pregnant women and fetuses are included in this research. Please answer all subsequent questions, indicating that follow-up of pregnant partners holds no direct benefit to the woman or fetus and all procedures will be no greater than minimal risk.
- If the study plans to complete follow-up of the child after birth, a children’s determination must be made. Please navigate to page Participants #3 to select Neonates and the ages of participants of less than 7 years old as a vulnerable population and add children and neonates justification to the vulnerable population sections.
2. If, however, you don’t anticipate its use, you can choose NOT to include it with your initial application, and add it later via an Amendment in case it becomes necessary. At that point you can follow the steps described above as part of the amendment and update study.
NOTE: If you’ve included this consent form as part of your original application, and suddenly get an IRB revision to complete the steps described above. You have the option to remove the consent form instead (IF you haven’t used it yet, and don’t anticipate on using it).
In summary: if a sponsor wants to add a pregnant partner consent form, you either do it and follow the steps above, or you don’t, and add an AM later in case it becomes necessary.
Investigational Drug Services (IDS)
Contact IDS and request an estimate (AKA bid) by providing the following information:
- Principal investigator name
- IRB / or that there is no IRB number yet
- Most recent source documents – Protocol – Investigator Brochure – Pharmacy Manual (if the protocol references one)
- Contact info. for study staff
- Start/end date of study
- # of pts expected to be enrolled
- Delivery route, IVRS (if applicable)
- Study visit location
IDS must be included in the SIV. Contact the IDS via email to coordinate availability – Advanced notice is required, minimum of 4 weeks!
Research Resources/Systems
Yes! There are options the DSS team has to assist in identifying potential eligible study subjects and can include PHI approved in the IRB. They can help you maximize clinical trial accrual/recruitment and study feasibility. Visit their Pulse page for full details.
- One option is the Human Subject Recruitment Tool (HSRT) which allows you to see the scheduled appointments for potential patients 10 days out and is updated weekly. HSRT also allows you to document if a patient is not eligible, refused, not approached, consented and you can document ad-hoc comments to assist you as you are establishing study patients.
- Another option is for DSS team to create a cohort of potential study patients and release names to you in batches as needed until the number of study patients consented is reached.
Helpful to starting the process are:
- Email datascience@hsc.utah.edu and provide them with the IRB #, so they can access ERICA (protocol)
- If the IRB hasn’t been approved, they can still access it and better understand what is needed and can begin work with the understanding that data will not be released until IRB approval.
- If there isn’t an IRB yet, they can still discuss what is needed and perform preliminary work.
- They may need to talk about further details with you on the phone/email or in person if you prefer:
- inclusion/exclusion criteria
- specific icd9/icd10 /cpt codes you’d like to include in the search (e.g. 285.9 Anemia, unspecified OR 285.2 Anemia of chronic illness OR both)
- Time frames for each criteria (e.g. last 6 mos, first date of dx, last recorded value, etc.)
- Specific locations you might be interested in
- Patient demographics you’d like to limit the results with (e.g. age >= 18, deceased patients included/excluded, etc.)
- Often times it’s useful for the investigator to provide a spreadsheet with columns (data elements returned) defined and a couple of example rows filled with example data so we can both understand what the expected result is. Not necessary, but might be helpful depending on the requested data.
- Also, it’s okay to not define criteria for any of the categories above (e.g. we don’t care about any patient demographics so don’t use them in the query).
There are several options available:
- As a coordinator, you can train to become a phlebotomist and draw blood from your study participants. Please see the Phlebotomy Training page for more information.
- You may use the ARUP outpatient lab
- You may use CCTS staff who can come to your clinic. (Please note: CCTS needs to be involved in your study set up and protocol, and they do charge specific fees for blood draws, as well as protocol review. They may also require certain advance scheduling notice).
- You may use (if possible) the clinic staff and MAs.
Please review the training and information related to Electronic Payment Request (ePR) on the ePR website, then complete the application for ePR access.
Study Conduct
The requirement for completing the 1572 and Financial Disclosure depends on whether there is an Investigational New Drug application (IND) for the study or not.
For PI-initiated clinical trials that don't have an IND, or have IND exemptions, the 1572 and FDFs are not required.
For a multi-site PI-initiated clinical trial with an IND, completion and submission of the 1572 to the FDA is required for the Sponsor-Investigator, and for all other PIs, as well as collection of FDFs from the other participating investigators.
For a single-site PI-initiated trial with an IND, the COI process associated with the IRB review and approval is good enough, and a specific FDF does not need to be created separately.
Include circumstances surrounding consent such as: who was present, what particulars were discussed, did the patient have time to review, was contraception discussed, what method of contraception was used, was a copy of the consent given to the patient, what date/time the patient was consented.
Any objective evidence that substantiates a particular inclusion/exclusion criteria should be included with source study records. Some examples include medical history from the provider, image results, labs, etc.
At least 3: Primary coordinator, a second coordinator or manager, and the Investigator.
NOTE: Minimal-risk and basic studies often have very minimal eligibility criteria, such as only participant age and willingness to provide informed consent. Studies such as these may utilize a waiver of authorization for recruitment purposes, and will not require a secondary eligibility review.
All source should be attributable. If a CRF is used as source make sure to include a signature of the person recording the information.
If the values recorded in a CRF have objective evidence recorded in an electronic medical record (EMR), source from the EMR should be printed and accompany the CRF in the study records.
Please refer to the SOP on this subject.
Main points are:
- Sponsors will generally send a SUSAR to all participating sites
- You will review it, and assess whether it meets the IRB reporting criteria. If you don’t yet feel comfortable doing this, you can also have the PI review the SUSAR, and determine that.
- If the PI/you determine that it is unexpected and reportable, you will have to submit a Report to the IRB (usually a sign of that would be that it increases risk to participants, and the sponsor sends you an amendment where you have to change the consent form etc. If none of that is the case, it’s usually not reportable).
- If the PI/you determine that it’s not reportable and doesn’t meet criteria for IRB submission, then you will simply file the SUSAR in the dedicated section of the reg binder. (Optional: you may write a brief note on the printed SUSAR (the first pg) i.e. ‘This event does not meet our IRB’s reporting criteria for unanticipated problems/events, therefore, it will not be reported’, the PI can date and sign under this statement before you file it in the reg. binder.
To avoid errors, it's best practice to enter data into your study’s database in a timely manner (1-2 days after collection).
There is a drop off until 3 pm at the Shipping Services on the A level; and a second drop off point on the 3rd floor at the School of Medicine (across the bridge next to the C elevators, to where the Dumke building used to be) with a drop off time of 4:45 pm.
UTRAC
CRCE Answer: Yes, it is 100% okay, and encouraged in many situations, to register your patients into uTRAC before consent takes place.
For example, if physicians hold specialty clinics in which it is expected that some of the patients will be approached for study participation, we encourage study teams to register potential study-qualifying patients into uTRAC at least a day before the clinic takes place. If the patient declines to participate or fails enrollment criteria, study teams simply update the patients as screen failures, withdrawals, etc. after the visit takes. uTRAC registration is considered a business need and does not conflict with other regulations related to human subject and PHI protections.
If a potential participant does not have an MRN (or if you are unsure the participant has one), you can request one via uTRAC. Doing so will prompt the HIM team to look for an existing MRN, and if none is linked to a patient matching your description, they will create an MRN. They will then send you the new or existing MRN. Please refer to “Patient Registration and Visit Tracking” tip sheet on Pulse.
Visit the CRCE Pulse page for tip sheets and guidelines.
Veterans Affairs (VA)
Yes! The VA does accept the U of U version of the CITI training, so you only have to do one! DO NOT complete the VA CITI if you have already completed the UofU Human Subjects Research Training in CITI. Simply provide your certificate of completion to Alan Betts (Alan.Betts@va.gov). Certification is valid for 3 years.