Dear SOM Clinical Research Community,
Thank you for your engagement, feedback and questions related to the new personnel Profile and Training System (PaTS) and SOM-wide Standard Operating Procedures (SOPs)! Please review the FAQs listed below. We will continue to add additional information to the CRSO website as we work to make new tools and processes clear and useful for the clinical research community.
I’ve been getting emails about PaTS profiles and SOPs. What’s the deal?
- PaTS is the new SOM Profile and Training System: All SOM faculty and staff engaged in human subjects research are required to login to PaTS and complete a brief profile. Essential resources, trainings, and SOPs will be issued based on specific roles and responsibilities identified in the profile.
- SOPs will be issued through the PaTS system, which will be specific to the responsibilities indicated on your individual profile. Once an SOP is issued, you will receive an automated email to review and attest to the SOP.
Questions about PaTS users:
Do faculty investigators need to create PaTS profiles?
Yes. All SOM faculty engaged in human subjects research are required to login to PaTS and create a profile.
Should all staff create a PaTS profile? What about temporary staff?
Yes. All SOM staff need to create and maintain a profile, regardless of position type or classification.
Should contract workers create a PaTS profile?
It’s optional. Faculty investigators and staff overseeing contract workers should decide if they want those contractors to create PaTS profiles, based on their scope of responsibilities, anticipated longevity of contract, and how they plan to deliver training to those contractors. If contractors do not utilize PaTS, they should review SOM SOPs relevant to their job duties on the CRSO website.
We have students helping out short-term on some of our research projects. Do they need to create a PaTS profile?
No. SOM faculty investigators and advisors should ensure that the students they oversee receive training relevant to their role and responsibilities, which may include review of specific SOM SOPs. All SOPs and other resources that will be issued to employees through PaTS will also be accessible on the CRSO website.
Should residents and fellows who are involved in human subjects research create a PaTS profile?
It’s optional. The requirement for PaTS profiles applies to employees of the SOM. Given that residents and fellows often fulfill integral roles in the conduct of human subjects research, they may find it beneficial to receive notification of trainings and SOPs that apply to their research roles and responsibilities directly through PaTS. If trainees choose not to create a PaTS profile, they should review all SOM SOPs on the CRSO website to ensure they follow those standardized procedures.
Questions about SOPs:
I am a faculty investigator who oversees a team of staff. The staff will consent our participants, but I never do. Do I need to review and attest to the SOP on informed consent?
No. You only need to review and attest to SOPs that are related to your direct responsibilities. However, PIs should consider reviewing the SOPs for activities they supervise to ensure appropriate understanding of the procedure(s).
I don’t directly obtain consent from participants, but I’m interested in reviewing that SOP. Can I do that?
Yes. The SOM SOPs are available for review by anyone with an onyen. You can review the SOPs in PaTS or on the CRSO website.
My unit already has an SOP on informed consent. Do we still need to review the SOM SOP?
Yes. SOM SOPs apply to all SOM human subjects research projects. The SOM SOPs are high-level and reflect broad best practices and applicable regulations. As such, the SOM SOPs should not contradict any unit-specific SOPs. You may choose to maintain your unit-specific SOPs in addition to the SOM SOPs or choose to discontinue your unit-specific SOPs and utilize complementary work instructions as needed.
If I receive an automated notification from PaTS that I have a new task, do I actually need to complete the task?
Yes. Notifications from PaTS are based on your individual profiles, so you will need to login and complete any tasks that are assigned to you.
What else will we get through PaTS, besides SOPs?
PaTS will be used to disseminate various training materials and resources, such as tip sheets, guidance documents, and brief presentations. By delivering these materials via PaTS, we can ensure that people receive useful information that is directly related to their specific job duties.
More questions about the new Adult Informed Consent SOP?
Please join an informational and question/answer session today or tomorrow: June 1st from 1:00-2:00 PM and June 2nd from 2:00-3:00pm. Click here to register for either session.