The IRB has posted Guidance for Investigational Device Studies on the Guidance Documents page. This guidance provides information for investigators to follow in determining whether a study falls under FDA Device Regulations for IRB review and oversight.
The IRB is changing the way study personnel Roles function in eRA. Starting Wednesday, July 25, 2016, the following changes will take effect:
- Individuals listed on studies in eRA with Co-Investigator with Edit and Research Coordinator roles will have the ability to view study documents and to create and submit study submissions such as Amendments and Continuing Reviews on behalf of a PI.
- A new role, Research Assistant, will be included in eRA. Personnel who may not have a direct role in the science of a research study but need to access and download documents from eRA for study activities can be assigned this role (Undergraduate and Graduate Research Assistants, etc.).
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This past April, the IRB welcomed a new Panel Coordinator, Misty White. Misty, a Certified IRB Professional, comes to us from, most recently, LSU Health Sciences Center in New Orleans, and her previous IRB experience includes several years at the University of Alabama at Birmingham. Here, she will coordinate all biomedical protocols and the convened IRB meetings. Please join us in welcoming Misty to the CU Boulder family!
In an effort to better serve our research community and streamline the review process, the IRB will change its procedures for all protocol submissions that require full board review. Starting June 23, 2016, all submissions requiring full board review will undergo an administrative pre-review before they will be scheduled for review at a convened meeting. The pre-review will ensure that only submissions that are complete and free of errors will go before the board. The change will affect how investigators determine timelines for submitting items to the IRB for review. Click the title above for more information.
Logging into the eRA application is about to get easier! Click through for more. Beginning Saturday, February 6, the process for logging into the InfoEd eRA portal will change.
The IRB has recently updated the HRP-211 Initial Application Form and Protocol Template to include questions specifically geared to assessing the data security requirements for all human research s
A new template for Pre-screening subjects, HRP-506: TEMPLATE - Pre-screening Consent Script, has been added to the Forms & Templates page.