| Date | Description |
|---|
| NOV. 15 | Some sponsors restrict the number of applications from a single institution for a grant call. If this is the case, the Office of Research organizes an internal selection process to identify the UC Irvine representatives. |
| AUG. 17 | Now you can request RSS services through our new and easy to use electronic application! |
| JULY. 29 | Office of Research will be closed from Thursday, July 29 until noon on Monday, August 2 while they relocate to their new offices in the University Research Park (5171 California, Suite 150, Irvine CA 92697). Don't forget to update your FDA Form 1572s to reflect the new address! |
| JULY. 19 | When negotiating upfront payments for industry-sponsored trials, make sure the terms specify that this payment is non-refundable. |
| JUN. 03 | When budgeting Coordinator time for clinical trials, remember to include the time spent preparing for each visit and completing CRFs, in addition to the time spent face-to-face with the patient. |
| MAY. 19 | When consenting patients, remember that family members are not authorized to sign as a witness. |
| MAY. 11 | Adverse events that occur on studies with the same drug used in the clinical trial you are participating in must be reported to the IRB, even though they did not happen to your patients on your study. |
| APR. 26 | When budgeting for your industry-sponsored clinical trial, remember to include benefits when calculating time spent on the project by the study staff members. |
| APR. 16 | Audits of studies may be performed by external entities, like the study sponsor or the FDA, or internal entities, like the IRB, UCI Medical Center, Contracts and Grants Accounting or UCI Research Compliance. |
| MAR. 30 | It is sometimes possible to add investigator-initiated translational study components to an industry-sponsored trial. |
| MAR. 19 | Some studies require a witness to sign the consent form...this person should not be a member of the study team. |
| MAR. 15 | Budgets for an industry-sponsored clinical trial must account for all costs associated with conducting the study including up-front and per-patient costs, as well as invoiced items such as informed consent translation, recruitment and advertising, IRB review, and pharmacy services. |
| MAR. 08 | In January 2010, NIH grant applications started requiring a new Research Strategy section that encompasses the previous sections of Background & Significance, Preliminary Studies/Progress Report, and Research Design & Methods. |
| MAR. 01 | When determining the full cost of performing a clinical trial, don't rely exclusively on the study flow chart. A careful review of the protocol will often reveal additional cost-generating activities. |
| JAN. 27 | Beginning this month, NIH biosketches should include a Personal Statement that addresses how the individual's experience and qualifications make them particularly well-suited for their role on the project. |
