August 24, 2020
For the Record – August 24, 2020
- New Development: Reporting Study Results to ClinicalTrials.gov
- Minor Changes to Zipline
- Significant Changes to WIRB’s IRB Application System
- Correction to COVID-19 Relative Risk Tool
New Development About Reporting Study Results to ClinicalTrials.gov
Federal regulations require most clinical trials funded by the National Institutes of Health (NIH) or regulated by the Food and Drug Administration (FDA) to be registered at the federal website ClinicalTrials.gov before the study starts. Researchers are also required to report the study results.
The FDA and NIH are paying more attention to completed trials that are delinquent in reporting the results. Recent actions include:
- Automated emails from the ClinicalTrials.gov system informing researchers about a recent federal court decision that requires FDA and NIH to more broadly apply and enforce the law.
- Release of a final FDA Guidance entitled Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank which describes the fines that the FDA can levy against researchers (not their institutions) for noncompliance.
- Communications from NIH reminding the biomedical community that NIH has the authority to respond to noncompliance by not releasing remaining funding for a grant or funding for a future grant.
These actions come in the wake of a federal court ruling on a lawsuit brought against FDA and NIH charging them with not enforcing the federal regulation.
Minor Changes to Zipline eIRB System
Implementation date: August 27, 2020
We are implementing some relatively minor changes to Zipline on August 27, 2020. Zipline will be unavailable for about 30 minutes that evening while the revisions are loaded into the system. The biggest changes are described below.
- New SmartForm question. A new question about the inclusion of UW employees as participant groups has been added to the Study Scope SmartForm. You will be prompted to complete this new question when you prepare a new application, respond to a clarification request for an ongoing application, or submit a modification to a currently approved study.
- IRB Protocol change. The reference to the retired CHECKLIST Human Subjects Research During the COVID-19 Pandemic has been replaced with a request to confirm the use of basic COVID infection and risk control measures. This slightly revised version of the IRB Protocol is already available on our website. It will become available through the link in Zipline after August 27.
- External Request Form change. The same change has been made to this form. This slightly revised version of the External Request Form is already available on our website. It will become available through the link in Zipline after August 27.
List of all changes. The Release Notes describing all changes to Zipline will be posted to the Zipline Release Notes page on August 27, 2020
Significant Changes to WIRB’s IRB Application System
Implementation date: September 6, 2020
Many UW industry-sponsored clinical trials are reviewed WIRB instead of the UW IRB.
HSD has learned that WIRB is implementing a significant upgrade to their online IRB application system (“Connexus”), on September 6. Online resources and training materials will be available from WIRB to support researchers with the implementation.
HSD plans to sponsor a WIRB-led, UW-specific training for the upgrade in October. Dates and information about registration will be announced in the next HSD eNewsletter. For information about the upgrade, contact Carmen Thompson, WIRB’s account manager for UW, at email@example.com.
Correction to COVID-19 Relative Risk Tool
Implementation date: August 19, 2020
An error in the scoring for participants ages 40-49 years old has been corrected. The originally published tool listed the risk score as “4”. The score has been corrected to “2”.
Our apologies for the error. See the corrected version here.