On September 16, 2016, the National Institutes of Health (NIH) issued a new policy stating that NIH-funded investigators and staff should be trained in Good Clinical Practice (GCP).1 This policy takes effect January 1, 2017. The policy applies to all NIH-funded investigators and staff “who are involved in the conduct, oversight, or management of clinical […]
In collaboration with the University of Maryland’s Center of Excellence in Regulatory Science and Innovation (M-CERSI), the Food and Drug Administration (FDA) is offering a free, three-day training session in Silver Spring, Maryland, in November, that may fulfill NIH’s new requirement for education in good clinical practice (GCP). This training course is intended to provide
FDA to Offer Three-Day Investigator Training Session in November Read More »
On September 16, 2016, the Department of Health and Human Services (HHS) issued a new regulation and the NIH has issued a new policy to increase the availability of information about clinical trials. The HHS Final Rule describes requirements for registering and submitting summary results information for certain clinical trials to ClinicalTrials.gov. A complimentary NIH
On September 16, 2016, the Department of Health and Human Services (HHS) issued a new regulation and the NIH has issued a new policy to increase the availability of information about clinical trials. The HHS Final Rule describes requirements for registering and submitting summary results information for certain clinical trials to ClinicalTrials.gov. A complimentary NIH
The Final NIH Policy on the Use of a Single Institutional Review Board (sIRB) for Multi-Site Research was published in the Federal Register on June 21, 2016. The post includes a link to guidanceon the Use of Direct and Indirect Costs for Single IRB Review under the NIH Policy and FAQson the policy and indicates
Final NIH Policy on Use of a Single IRB for Multisite Research Read More »
UCI students, staff, faculty and research personnel can now log in to the Collaborative Institutional Training Initiative (CITI) website using their UCINetID and password. This process, known as Single Sign-On or SSO, provides distinct advantages over the old system of individual account access: ·Enhanced security ·No additional Username/Password for users to remember ·Automatic log-in if
New Procedure for CITI Training Read More »
NIH has changed its policy regarding Recombinant DNA Advisory Committee’s (RAC) review of individual human gene transfer trials. Effective April 27, 2016, UCI’s Institutional Biosafety Committee will determine whether investigator-initiated research requires RAC review based on specific criteria. The RAC Revision Factsheet includes a list of the criteria and a summary of the changes. Also
Dear Researchers, We are launching a new application for reporting Unanticipated Problems (UP) on May 04, 2016. Any draft versions using the current AE/UP application must be submitted by April 29, 2016 5:00PM. All un-submitted drafts will be deleted after this date. Please look for upcoming announcements regarding the new UP application process.
Anticipated Launch of a new application for reporting Unanticipated Problems Read More »
Dear Colleagues: This is to let you know that there is a Senior ERA Analyst position open on the Electronic Research Administration (ERA) team. The summary of the job is: Under the general direction of the Assistant Director, Electronic Research Administration (eRA), and in collaboration with Research Administration (RA) and Office of Information Technology (OIT),
New position: Senior ERA Analyst Read More »
HHS Proposal to Improve Rules Protecting Human Research Subjects Comment period extended to new deadline – January 6, 2016 Dear Researchers, The Department of Health and Human Services and fifteen other Federal Departments and Agencies are extending by 30 days the comment period on the Federal Policy for the Protection of Human Subjects
