TransCelerate BioPharma (TransCelerate), a nonprofit organization dedicated to improving the health of people around the world by accelerating and simplifying clinical research, today announced the ...
Background Complex breast surgery, including immediate breast reconstruction and oncoplastic procedures, is increasingly performed to optimise oncologic and aesthetic outcomes. Postoperative wound ...
A protocol deviation or violation is any departure from the study procedures or treatment plans as specified in the IRB-approved protocol. Protocol deviations occur when an investigator does not ...
This guidance provides directions for researchers using measures that involve questions related to suicidal ideation. Research shows that asking questions related to suicidal ideation (SI) does not ...
All submissions requiring IACUC review are assigned for review as they are received. Most protocols are reviewed and approved via designated member review (DMR), which allows approval once all review ...
The flowchart and steps below outlines the best practice for processing industry-written and sponsored clinical trials at UAB. There are many small steps in each of the larger defined steps (see flow ...
The Principal Investigator (PI) is responsible for reviewing this policy and complying with its requirements. Specifically, the PI will: You may use the protocol template to record your information ...
Follow the step-by-step instructions below to successfully maintain and close a protocol with the IRB. Instructions below include information about continuing reviews, amendments, event reporting (new ...
The Post Approval Monitoring (PAM) team within Research Regulatory Affairs aims to help ensure the well-being of humans and vertebrate animals involved in research. Authorization for researchers to ...
DALLAS, October 24, 2025--(BUSINESS WIRE)--Hospital for Special Surgery (HSS), the world’s leading academic medical center focused on musculoskeletal health, today announced the results of a ...