Achieving Data Quality and Integrity in Clinical Trials Involving High Consequence Pathogens — Clinical CourseFDA-UTMB Collaborative Education Program

Q1: Are there any fees associated with attending this course?

A1: No! The course is funded by an educational grant through the U.S. Department of Health and Human Services Food and Drug Administration (FDA). In-person attendees will be responsible for expenses related to travel.

Q2. What is the difference between pre-registration and course admittance?

A2. Admittance to the course, whether attending in-person or virtually, is a 3-step process. While course organizers try to accommodate all requests, the total number of attendees is limited; therefore, admittance is based on availability. After completion of Steps 1 and 2, you will be notified if you have been admitted to the course. Please allow up to 30 days for the admissions process. Step 3 is your acceptance to the course invitation. Upon admission, you will receive additional information.

Q3. I submitted my pre-registration information, but I have not yet heard whether I have been accepted into the course. What should I do?

A3: First, please check your Spam folder to be sure that the email has not been blocked by a firewall. If you have not received notification after 30 days from completing Steps 1 and 2 of the pre-registration process, please send an inquiry to orncs@utmb.edu. If you need to inquire on the status of your application in order to make travel reservations, you may also send an email to orncs@utmb.edu.

Q4: I am attending the course and have a colleague who will benefit from this knowledge. Can I share the meeting link with them?

A4: We are happy to hear that the content is relevant; however, we must track all attendees. If your colleague would like to have access, please email a request to orncs@utmb.edu and someone will contact them directly.

Q5: I am attending the course in-person. Is it possible to attend some lectures in-person and some virtually?

A5: As there are a smaller number of individuals admitted for in-person attendance, in-person attendees are kindly reminded that someone else may be on a waiting list to be admitted. If there are unusual circumstances that require flexibility, please email your request to orncs@utmb.edu and course organizers will do their best to accommodate.

Q6: I registered and was admitted to the course to attend in-person; however, I am now unable to attend in-person. What should I do?

A6: Please send an email to ORNcS@utmb.edu as soon as possible. Course organizers can switch you from in-person attendance to virtual if you are still available to attend. Additionally, we can release your in-person seat to someone on the waiting list.

Q7: I am attending the course virtually. Will I be able to submit questions to the presenters?

A7: Yes! There will be a mechanism for submitting your questions. Instructions will be shared on the first day of the course.

Q8: Will a certificate of completion be provided?

A8: Yes, a certificate will be provided for those who attended the course in its entirety. We closely monitor online attendance for this purpose. For attendees seeking full or partial Continuing Education (CE) credits, instructions will be provided during and after the course. For virtual attendees, please assure you are consistently using the same name (first and last) and email for registration and course participation. If you experience an emergency that impacts your ability to participate fully, please email the course organizers at orncs@utmb.edu.

Q9: If I am unable to attend the entire course (in-person or virtual), will I be able to get a course certificate?

A9: Please email the course organizers at orncs@utmb.edu and someone will contact you. If you will miss the majority of the course, you can be placed on a priority list for the 2025 course. If you will only miss a few sessions, we can provide instructions for claiming partial CE credits.

Q10: I am registered to attend the course virtually; however, can I attend the mock exercises on Day 3?

A10: These activities are reserved for in-person attendees. You can make a special request by emailing orncs@utmb.edu; however, please note that capacity is limited. Please make this request as early as possible.

Q11: I will need a VISA to enter the US to take this course. Will you provide any sponsorship?

A11: You may use your course invitation and the meeting website to help support your request. If you require any further written documentation, please email your request to orncs@utmb.edu. Course organizers will try to accommodate by providing additional information as needed; however, we are unable to contact the respective Consulate directly. Please note that no financial assistance is available to offset travel expenses.

Q12: Will Continuing Education credit be available for attendees?

A12: Yes. Course organizers submit applications to certify the course for Continuing Nursing Education (CNE) and Registered Quality Assurance Professionals (RQAP). Once the course is approved, the accreditation information will be posted on the course website and Whova (course management application).  Instructions on how to claim credit will be provided at a later date.

Q13: I am registered to attend the course, when can I expect to receive additional course information?

A13: All registered attendees will receive an email approximately one week prior to the course start date that will contain additional information. If you do not receive information, check this website for general announcements or email orncs@utmb.edu.

Q14: Will I need to download any applications prior to attendance?

A14: The course will be administered through the WHOVA event management platform. Instructions will be provided on how to access the course. UTMB has received authorization by FDA IT for use by FDA employees. For virtual attendees, lectures will be provided in Whova. Whova will have embedded streaming links through Zoom. Please ensure you can access Zoom. IF YOU ARE NOT ABLE TO DOWNLOAD THE WHOVA APPLICATION, please notify Katherine Rosen at kerosen@utmb.edu.  

Q15: I did not indicate during course pre-registration that I wanted to take the online GCP course, but I would now like to take the course. What steps should I take?

A15: Please email your first and last name along with your email address to orncs@utmb.edu and indicate that you would like to take the Basic GCP course. Course organizers will assure you are given access.

Q16: I indicated my interest in taking the online GCP course. When will I have access to the course and how long will I have access?

A16: You will receive an email from UTMB@Reach360.com with access information. Access will be granted for approximately six weeks starting 1-2 weeks prior to the course start date.

Q17: Will the presentation slides be made available to attendees?

A17: Presentations will be provided after the course for sessions where faculty provided consent to release. Some information may be redacted.

Q18: Will sessions be recorded and available for attendees?

A18: No, sessions will not be recorded for the purpose of viewing by course attendees. Some sessions may be recorded to aid in future course development.

Q19: I am an in-person attendee and am planning to sign-in each day using the WHOVA App. Do I also need to physically sign-in each day?

A19: Yes, please physically sign-in as you arrive each day.

Q20: Will there be parking on campus?

A20: In-person attendees will receive parking information in a Logistics email that will be sent approximately one week prior to the start of the course.

Q21: Will lunch be provided?

A21: No, lunch will be on your own. Information will be provided in a Logistics email that will be sent approximately one week prior to the start of the course.

Q22: I need to travel home on Thursday. Will the course end early to allow time to travel to the airport?

A22: Yes, the course will end around 3:15 pm on Thursday, August 1, 2024. This will allow ample time to commute to the airport. Eppley Airfield (OMA) is approximately 6 miles from the UNMC campus.

If you do not find an answer to your question, please send your inquiry to orncs@utmb.edu. Please include your name, email address, and state this is a question related to the UTMB/FDA Clinical Course.