New NIH Requirements: For Registering NIH-Funded Clinical Trials on Clinicaltrials.gov and for Good Clinical Practice (GCP) Training
As of January 2017, NIH has implemented two new requirements in regards to clinical trials. These requirements are related to registering clinical trials on clinicaltrials.gov and good clinical practice (GCP) training. In order to address these new requirements, the CRC IRB has revised the IRB forms to include sections for clinical trials registration and good […]
Institutional Review Board (IRB)
New requirement for registering NIH-funded clinical trials on clinicaltrials.gov
On January 18, 2017, an expanded policy of the National Institutes of Health (NIH) goes into effect that requires that clinical trials funded in whole or in part by the NIH are registered at ClinicalTrials.gov, and that results information of these trials is submitted to ClinicalTrials.gov. When applying for IRB approval, you still need to […]
Tips for Creating a Consent Document
Getting Started The consent form or study information sheet is a document used to guide your consenting process. The consent form should include several sections, which are called “elements.” To help investigators create a consent document that includes all of the necessary elements, and is more readable, the IRB has created consent/assent form templates. We […]
Technology Equipment Request Form
Assent Form Template
For use when the study plan is to enroll children age 12 years and older. Consent of the parent is documented on the separate Consent Form.
Request for Modification Response Form
Use to document the principal investigator’s response to IRB requests for additional information made during the review of an IRB submission.
Event Form (Replaces the Deviation & Unanticipated Problems Forms)
This form is to be completed to report: Unanticipated problems or adverse events involving risks to subjects or others, exceptions, deviations, new information, and other problems/events.