The CRSO is excited to announce that the following new and revised SOPs will be issued today for the SOM clinical research community and posted in the Clinical Research Profile and Training System (PaTS). The SOPs will take effect on December 14, 2023.
New SOPs:
- SOM SOP 201.1: Developing and Maintaining Clinical Research Standard Operating Procedures for Individual Units
- SOM SOP 402.1: Obtaining and Documenting Parental Permission and Child Assent
Revised SOP:
- SOM SOP 401.2: Obtaining and Documenting Informed Consent from Adult Research Participants
If you have created your PaTS profile and indicated that you have the responsibilities that are relevant to the above SOPs, you will receive an email notification from PaTS that the respective SOP(s) has been assigned to you for review and attestation. Please note, you will be required to review and attest to any new versions of an existing SOP.
Instructions for attesting to an SOP are available on the CRSO website. For full functionality of SOP links in PaTS, download a copy of the SOP. You may also download the SOPs from the CRSO website.
What is next?
- Be sure that you and all members of your research team engaged in human subjects research have created a PaTS profile.
- Login to PaTS to review the SOP(s) and complete your attestation(s), no later than December 14, 2023.
The CRSO will host two informational sessions to provide a general overview of the new SOPs, answer questions, and demonstrate how to attest to the SOP in PaTS. Similar information will be presented at both sessions.
Click the date and time below to register for the session(s) that works best for your schedule.
Wednesday, November 29, 2023
Friday, December 8, 2023
If you have any questions about the SOP, PaTS, or the informational sessions, please email crso@med.unc.edu.