Summer 2018 Continued
Status of ̽̽Click Project
- Demonstrations to the community are complete.
- Training has begun with our IRB Committee chairs.
- Formal Instructional Guides and FAQs are being created and will be posted to ̽̽Click Toolkits and FAQs (opens in new window).
- Formal training sessions for the community will be posted on the website within the next few weeks.
- A go live date will be announced as soon as we have stabilized our data transfer processes.
More ̽̽Click Advantages
- ̽̽Click has as folder tab that includes the currently approved materials only. No more sifting through multiple electronic versions to find the approved documents. Therefore, ̽̽Click can be your system of record.
- ̽̽Click allows us to electronically stamp approvals on the protocol documents resulting in a cleaner approved document.
- Continuing review reminders are tied to the protocol’s expiration date versus the current arbitrary 1st of each month. This will provide you with actual 30, 60, 90 day deadlines that correspond to expiration.
- PIs can go into the system one time to make a study team member their proxy (designee to edit and submit on their behalf) for multiple protocols.
Countdown to Go-Live
- Investigators who have not completed the Human Subjects Training or GCP Training in CITI to date (opens in a new window), need to do that as soon as possible. This will allow your certification to be captured easily within ̽̽Click and place you in the queue for subsequent refresher training reminders.
- Investigators/designees need to continue to respond to as many outstanding IRB items as possible to allow the submissions to be transferred into the ̽̽Click system with an approved status.
IRB Submission Deadline Change for Full Committee Review
Beginning with October’s full Committee meetings, the CHRMS and CHRBSS submission deadline for new protocols requiring full committee review will now be four weeks prior the meeting date. This change is to provide additional time for more thorough pre-reviews by RPO analysts, and to accommodate the different workflow in the new electronic submissions software, ̽̽Click.
Visit our website for a full list of meeting dates and deadlines (opens in a new window).
IRB Policy/Procedure Updates and Additions and Form Changes
New Section 1.4 Public Records and Open Meetings (Vermont Law)
As a public body, the University is subject to the Vermont Public Records Act and the Vermont Open Meetings Law. These two laws require that ̽̽ allow public access to records and meetings. There are certain categories of exemptions from this requirement which are outlined in this new section.
Revised Section 9.2 Surrogate Consent for Research (Legally Authorized Representatives)
This policy contains revised language which clarifies that the protocol must specify the sequence of steps, and the qualifications of the study personnel that will be employed to assess capacity to consent and to acquire and document surrogate consent if appropriate.
New Section 10.3 European Union (EU) Participants and EU General Data Protections (GDPR)
GDPR went into effect on May 25, 2018 and regulates the use, access, collection, and processing of all personal data from the European Economic Area (EEA). GDPR’s application is broader than that covered under HIPAA. This section provides guidance as to how GDPR may affect US researchers.
New Section 13.1 SMART IRB
Describes the role of the SMART IRB in the NIH Single IRB Review policy.
New Consent Process Documentation Form
Good Clinical Practice (GCP) for clinical trials research recommends that you have documentation of the consent process for each research participant. We have recently added a second template example, that may be modified to fit your protocol’s consent process.
Clarification on Requirements for Good Clinical Practice Training
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials. Compliance with GCP provides assurance that the study data are credible and accurate and that the rights, safety, confidentiality and well-being of research participants are protected.
GCP training is required for all NIH-funded investigators and key personnel who are involved in the conduct, oversight or management of clinical trials involving Human Subjects. For more information, see the and the 12 minute podcast . The can be found through the Office of Extramural Research under News & Events » Virtual Learning » All About Grants Podcasts » Episodes » Understanding the Definition of a Clinical Trial & What That Means for You.
As notified by email on June 8, 2017, all Larner College of Medicine research investigators and key personnel are required to complete GCP training regardless of whether the research project fits the NIH clinical trial definition. Please ensure both Human Subjects and GCP training, as appropriate, are complete for all study personnel prior to protocol submission.
Educational Opportunity
̽̽’s Office of Clinical Trials Research and Sponsored Projects Administration are excited to offer Vanderbilt University’s “Getting Started in Sponsored Research” webinar series this fall. During the 1-hour sessions, which are open to the entire research community and are offered at no cost, you will be able to both view Vanderbilt’s live 30-minute webinars and participate in discussions about local and institutional policies and procedures with a representative from ̽̽’s SPA. Each session is offered twice during the fall semester. Please visit the for locations and times of the second 6 sessions and to add any of the events to your calendar.
|
Session |
Series 1 |
Session |
Series 1 (continued) |
|
Context for Sponsored Research |
Sept 5, 2:00 PM Med Ed 206 |
Lifecycle of a Project, Part 2 |
Sept 26, 2:00 PM Med Ed 206 |
|
Understanding the Language |
Sept 12, 2:00 PM Med Ed 206 |
Research Integrity |
Oct 3, 2:00 PM Med Ed 206 |
|
Lifecycle of a Project, Part 1 |
Sept 19, 2:00 PM Med Ed 204 |
Supporting Research |
Oct 10, 2:00 PM Med Ed 206 |
For more information contact research.navigator@med.uvm.edu or 656-9404.
̽̽ Research Faculty/Staff who have not yet completed ̽̽ Research Credentialing for FY19
This is a reminder to ̽̽ Research faculty and staff to complete their ̽̽ Research Credentialing for the current fiscal year, FY’19.
For the purpose of this requirement, clinical research activities include all research projects utilizing human tissues that are acquired within ̽̽ Medical Center in addition to projects involving direct patient interface or health record data review. Overall, if ̽̽ research personnel are inside ̽̽ Medical Center for research purposes (even if this does not include direct subject contact), then they are required to be credentialed.
You should not conduct research activities associated with ̽̽ Medical Center patients and resources until your ̽̽ Research Credentialing is complete. Faculty or staff who do not complete their credentialing will have their access to ̽̽ Medical Center patients, data and facilities revoked.
For more information regarding ̽̽ Researcher Credentialing please visit the Office of Clinical Trials Research website, , for information on what is required for a renewal badge.
If you have questions regarding the renewal process please contact us at 656-8990 or email us at ClinicalTrials@med.uvm.edu.
Adverse Events Reporting Using the Hospital SAFE System
̽̽MC has a mechanism for reporting actual or near miss adverse events using the SAFE system. It is especially important to report actual or near miss adverse events which involve research subjects participating in a research protocol. Please make sure the pertinent research protocol information, including CHRMS number, are included in the SAFE Report. Additionally, noting that a patient is enrolled in a research protocol even if there does not appear to be a relationship between the research and the adverse event is helpful as well.
The IRB is required under federal regulations to submit any unanticipated problems (UAP) involving risk to subjects or others to the Office for Human Research Protections (OHRP). While not all adverse events are UAPs, adverse events are evaluated by the Safety Subcommittee of the IRB and if it meets certain criteria, the IRB must take additional steps to submit this to OHRP. The SAFE report contains vital information for evaluating the adverse event so when submitting an adverse event report to the IRB it is important that it is accompanied by the SAFE report that was filed at ̽̽MC.