Webinar Sep 14th: Session V - ClinicalTrials.gov Registration & Reporting Guidelines and Best Practices ▾

TO: University of Maryland Baltimore Research Community

Please join us.

Date: September 14th, 2023    11:00 -  12:00 am via Webex Event. (session will be recorded).

Title: Session V - ClinicalTrials.gov Registration & Reporting Guidelines and Best Practices

Speaker: Anthony Keys, MBA, PMP, Johns Hopkins University

Among other topics in this session, Mr. Keys, will discuss:
-Follow up to Non-Compliance and latest developments of actions taken!
-What to expect
-Update on all things CT.GO
-Discuss Funding withholds/warning letters.

Webinar Link:  https://umaryland.webex.com/umaryland/j.php?MTID=m787edf320e56d5d79f6acfd52dc11723

Webinar number: 2624 694 0329
Webinar password: WRrr6xjfH53 (97776953 from phones and video systems)

Human Research Protections (HRP) is a comprehensive program that affords protections for all human research participants and is under the direct leadership of the Vice President and Chief Accountability Officer. This website provides up-to-date information related to conducting research with human participants.

Institutional Official (IO), Dr. Susan Buskirk

The IO is responsible for ensuring that the Human Research Protection Program (HRPP) functions effectively and that the institution provides the resources and support necessary to comply with all requirements applicable to research involving human subjects.     Dr. Buskirk's IO Appointment Letter

UMB HRP Components

The main focus here is to provide information, resources, and instructions for completing the review process through the IRB. While the IRB is a key player in the HRP program, there are many other components within UMB critically involved in protecting human participants. Click here to learn more.

What Can Be Found Here

For Researchers: This resource helps investigators design, write, and organize research protocols; maintain compliance with policies and regulations; create and submit IRB applications via CICERO.

 

HRP Office: Information regarding its role in coordinating the Human Research Protections Program and providing support for the UMB Institutional Review Board (IRB). Contact information and informatics regarding submission processing times.

 

Institutional Review Board (IRB): Information about the board and the executive members and their role in approving, monitoring, and reviewing biomedical and behavioral research involving humans.

 

For Research Participants: This section assists former, current, or prospective human research participants in obtaining information or offering input regarding research and clinical trials.

Announcements

(Click to read all Past Announcements)

Recorded Webinars - Session I, II, III, and IV: ClinicalTrials.gov Registration & Reporting Guidelines and Best Practices ▾
Tony Keys, Johns Hopkins University, explains the regulatory requirements related to clinical trials.gov and answers any questions you may have about common issues responsible parties encounter when using the system.

Session I:

Recorded Webinar Link: https://umaryland.webex.com/umaryland/ldr.php?RCID=eda6b84a72c906535e6fada7b0382bf3

Webinar Slides: Webinar Slides CT.gov Session I

Session II:

Webinar Slides: Webinar Slides CT.gov Session II

Session III:

Recorded Webinar Link: https://umaryland.webex.com/umaryland/ldr.php?RCID=86197e3a6b37f4aef42d767fe7c62314

Webinar Slides: Webinar Slides CT.gov Session III

Session IV:

Recorded Webinar Link: https://umaryland.webex.com/umaryland/ldr.php?RCID=ced442327142705cc607f1e2df1be144 

Webinar Slides: Webinar Slides CT.gov UMB Session IV

Recorded Webinar UMB Research Compliance Education - Research with Prisoners ▾
Held March 2, 2023, A Review of the Federal Regulations Pertaining to Research with Prisoners presented by Julia Gorey, JD, Department of Health and Human Services (HHS).

Title: A Review of the Federal Regulations Pertaining to Research with Prisoners.

Speaker: Julia Gorey, JD

Julia Gorey serves as a Policy Analyst in the Office for Human Research Protections, Division of Policy, Department of Health and Human Services (HHS), and is charged with writing and interpreting guidance and policy for 45 CFR part 46, the HHS regulations for the protection of human subjects in research. In addition to general responsibilities, she oversees the administration of subpart C and the review and authorization of human subject research involving prisoners; she also serves as Executive Director of the Secretary’s Advisory Committee on Human Research Protections (SACHRP), which provides expert advice and recommendations to the Secretary, HHS, on issues relevant to research involving human subjects with a particular emphasis on vulnerable populations. She is a University of Maryland Francis King Carey School of Law alumnus.

Recorded Webinar Link: https://umaryland.webex.com/umaryland/ldr.php?RCID=b6625c743e2521293c0e43600ad584ab 

UMSON November Research Seminar: SMART IRB Process and External IRB Reliance at UMB ▾
November 22nd, 2022 - Cloud recording of the UMSON Research Seminar regarding the SMART IRB Process and External IRB Reliance at UMB.

View the recording - https://umaryland.zoom.us/rec/share/Uci8G92eInCBSU5dUpQa5r50BgBoK7XS3ubbULHoB7GGok9_ngh1FO1dMM9zAe-B.ZOB5SYuiSNZ7gCcJ

Passcode = P%a?xa5!