What information should be included in new information reports about halts to study visits/procedures?
Last updated: 03/19/2020
To facilitate review and avoid delays, study teams should be sure to address the following when submitting New Information reports related to COVID-19:
- Do not include specific end dates for the proposed halts/changes. Instead state:
- Regular study activities will resume once UW guidance deems it safe to do so (this avoids having to submit any follow-up reports in case currently predicted end dates are changed)
- Address what study activities are being HALTED as well as if any study activities WILL CONTINUE (e.g. many studies have some activities that are already approved to be completed remotely like questionnaires, subject activity diaries etc.).
- Note: You do have the option of submitting a change of protocol to allow for completion of study activities remotely. See our guidance for further details: https://kb.wisc.edu/images/group78/98594/UWHC_COVID-19_Guidance.pdf
- Note: Face-to-face interaction for NON-therapeutic studies must be halted.
- Directly address if you are halting/altering subject safety visits/follow-up
- IF NECESSARY explain how many subjects are currently participating in the study and at what point they are in their participation.
- Describe how changes to subject safety/monitoring visits will be handled and how any risks to subjects will be mitigated.
- Changes made as a result of drug shortages or delays should specifically address:
- How the shortage/delay impacts subject safety, if at all.
- Any steps being taken to mitigate risk.
- Briefly describe how new information is being communicated to subjects. In cases involving interruptions to ongoing study participation and/or changes to subject monitoring, instructions for drug administration, etc. more details may be necessary, including the provision of any subject-facing written communications.
- If this is a multi-site study for which the UW HS/MR IRB serves as the reviewing IRB for external sites include how you will be communicating this information to the other sites and confirm they are either following their local guidance on COVID-19 or UW's (if they do not have guidance of their own).