June 8, 2021
For the Record – June 8, 2021: CT.gov, Connexus, Records Retention
- FDA Issues First Notice of Noncompliance
- WCG (WIRB) Legacy Connexus Retirement
- Revised Retention Requirement for Consent Forms
FDA Issues First Notice of Noncompliance with ClinicalTrials.gov Results Reporting Requirement
On April 27, 2021, the FDA issued its first ever Notice of Noncompliance letter for failure to comply with the requirements for submission of clinical trial results to ClinicalTrials.gov. The Responsible Party has 30 days to submit trial results or face civil monetary penalties of up to $12,316 per day.
For UW research, identification of an ‘applicable clinical trial’ that requires registration and results reporting on ClinicalTrials.gov is made by HSD and communicated to the researcher via Zipline. Researchers who have been identified as the Responsible Party for an applicable clinical trial should ensure they understand the reporting requirements and timelines for submission. Information regarding this can be found on the HSD website.
In its public announcement, FDA indicated it has issued more than 40 Pre-Notices of Noncompliance, which precedes a formal Notice of Noncompliance letter. UW researchers who receive one of these Pre-Notices should contact HSD at email@example.com for guidance.
WCG (WIRB) Legacy Connexus System Retirement
Researchers using WCG (WIRB) IRB must register for the new IRB system
On July 1st WCG IRB will retire its legacy Connexus online submission platform and transition entirely to the new WCG IRG Connexus. After that date, the legacy Connexus will no longer be available. To view any previously submitted studies and to submit any materials to the WCG IRB you must use the new Connexus.
Everyone with an account in the legacy Connexus already has an account in the new Connexus. However, this new account must be activated in order to use the platform. To activate your account:
- Navigate to https://connexus.wcgirb.com/
- Click “Forgot Password”
- Use the email address associated with your legacy Connexus account and follow the instructions to reset your password
- Login to the new Connexus using your new password
If you already have an account in the legacy Connexus do not create a new account in the new Connexus. If you create a new account you will not be able to view any studies associated with your account in the legacy Connexus.
WCG IRB is providing several online trainings on the new Connexus. Dates and times and instructions for registration are on the WCG website.
Important Information about Approval Documents. In order to perform post-approval activities such as documenting IRB approval in Zipline, communicating the outcome to OSP, and performing a post-approval consent audit, HSD requires copies of approval documents from external IRBs. Within the legacy Connexus, HSD (via firstname.lastname@example.org) was automatically added as a contact to every UW study submitted to WCG IRB. This activity was invisible to research teams and allowed HSD to view and receive the necessary documents without the involvement of research teams. This automatic function is no longer available in the new Connexus. This means that you must manually associate email@example.com with each study you submit in the new Connexus in order for HSD to see the study in the new Connexus and receive notifications of outcome documents. If you do not associate firstname.lastname@example.org with a study in Connexus, HSD will not receive outcome documents and you may experience a delay in the release of funds or post-approval audit activities. To associate email@example.com with a study, Site Managers can add contacts to a site by:
- From the Site Details page, select the appropriate study
- Click on Manage Contacts on the top right, then type, firstname.lastname@example.org in the field “Add users by name or email”
- Select Permission type, “Manager” from the drop down
- Click, “Invite”
These instructions are also on HSD’s External IRB Checklist for UW Researchers.
Revised Washington State Retention Requirement for Consent Forms
UW Records Management Services recently published the news that the State of Washington has increased the retention period for signed consent forms, from the previous 6 years to 8 years after the close of the study. This applies to existing and future: consent forms signed by adults or legally authorized representatives; parental permission forms, and assent forms from minors or decisionally-impaired adults. Please contact Records Management Services if you have any questions.