Dear Clinical Research Community,

������ Health’s Investigational Drug Services (IDS) will be relocating to a new facility on Page Road in Fall 2024. This decision stems from the recognition of significant capacity limitations and operational challenges within current space, necessitating a move to facilitate continued growth for current and future needs and to enhance operational efficiency. The new facility will offer continued growth in production, storage, and distribution capabilities and enable IDS to meet study sterile compounding requirements. This relocation will be an opportunity for IDS Pharmacy to better support the needs of not only research conducted at ������ Hospitals but also at other entities across the ������ Health system.

We recognize that the relocation of IDS’s hub will require ongoing communication, coordination, and collaboration. One ������ Clinical Research leadership (with engagement from various clinical research stakeholders) and IDS leadership are partnering closely to ensure a comprehensive understanding of all potential impacts to clinical research (e.g. related to timing, delivery, costs, sponsor engagement, etc.), as well as IDS operational and compliance requirements.

Please note the following:

• We will soon be distributing a survey to collect specific operational and regulatory details about all active IDS studies to inform planning for providing products following the IDS move. Assessing this information now will ensure IDS is prepared to support any conditions that may be required by specific studies and/or products.
• IDS will continue to operate as a hub-and-spoke model with the hub newly based at Page Road; and IDS will maintain support and collaboration with local pharmacies including Eastwone, ������ Hillsborough, Rex, Cary, Wakefield, Nash, Children’s Raleigh, with opportunities to expand to additional locations.
• IDS will establish a local “spoke” for receiving and distributing products at the ������ Chapel Hill hospital. The ������ Chapel Hill hospital IDS spoke staff will ensure appropriate receipt of products from the Page Road hub, complete required documentations (e.g. temperature logs), maintain chain of custody, and manage all logistics for daily distribution of products.
• IDS will have products couriered to the ������ Chapel Hill hospital spoke at scheduled intervals and with a direct courier route based upon study needs.��We recognize there will be specific requirements for some products, which will be assessed via the survey.
• No additional costs related to courier services will be applied to current/active��studies receiving drug at the ������ Chapel Hill hospital through FY25. IDS and One ������ Clinical Research leaders will continue to evaluate needs and operating models and any future changes will be communicated with advance notice of such changes.
• IDS and One ������ Clinical Research are beginning to explore establishing a service level agreement between ������ Health and the University to ensure ongoing optimization of processes and abilities related to managing investigational products for research.

We will continue to engage stakeholders to inform this initiative and will provide further updates as they become available. Please be assured that we will work to ensure any potential impacts to clinical research are fully understood and appropriately managed or mitigated.

If you have any questions or concerns, feel free to contact us directly.

Thank you,

One ������ Clinical Research
������ Chapel Hill & ������ Health

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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 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.

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Clinical research staff are essential to the successful conduct of clinical research studies and trials. We recognize that a strong and sustainable clinical research workforce is key to ensuring the quality and productivity of the clinical research enterprise of the ������ SOM, ultimately developing knowledge that will improve the health and wellbeing of North Carolinians and others whom we serve.

Feedback from clinical research staff across the SOM has shown that there is a need for clear career pathways and more robust career development opportunities for current and future personnel. To accomplish this, the CRSO has developed the SOM Clinical Research Staff Career Development Initiative (CDI), which aims to create career ladders and a competency-based career advancement model for the clinical research staff workforce by:

1. Creating standardized positions that accurately reflect job duties and align with market standards
2. Standardizing the creation of new clinical research staff positions through a centralized and objective process
3. Mapping current SOM clinical research staff positions into the standardized positions

The CRSO is partnering with SOM Human Resources and the ������-CH Office of Human Resources to accomplish the above objectives. As the first step of the CDI, we have created 15 standardized position descriptions based on review of current clinical research positions within the SOM, available SHRA and EHRA job classifications, and feedback from diverse stakeholders. Both the standardized process for the creation of new clinical research staff positions and mapping process to map current clinical research staff positions into the standardized positions are anticipated to begin later this year.

We have listed some common FAQs below, but you can find more FAQs and information about the initiative at /crso/career-development-initiative/.

We look forward to working with all of you to accomplish this important initiative for SOM clinical research staff!

Thank you,

SOM CRSO, SOM Human Resources, ������-CH Office of Human Resources

FAQs:

What if I have questions or concerns?

Feedback and partnership from the SOM clinical research community will be critical to the CDI initiative. If you have any questions or comments regarding the initiative now, please submit them to the CDI team using the following REDCap form: .

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When will this go into effect?

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The staff career development initiative will be implemented in phases. Creation of the standardized position descriptions has been completed. Next, we will roll-out the process for centralized support for the creation of new positions. We anticipate that beginning Summer 2023. Following that roll-out, we will begin the mapping process for existing positions. We anticipate that beginning Summer/Fall 2023.

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Is this required for all SOM departments?

Yes. All SOM departments will be included in this initiative.

What are the standardized positions?

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There are 15 standardized positions that are available for review on the CRSO website here: /crso/career-development-initiative/career-development-initiative-position-descriptions/

How were the standardized positions created?

The standardized position descriptions were created based on information shared by peer institutions who have completed this process, feedback from experienced supervisors and managers across the SOM, and with guidance (and approval) from SOM HR and OHR personnel.

Do the new SHRA positions fall within current North Carolina state competency profiles and salary banding structures?

Yes. We are not creating or modifying any North Carolina state competency profiles or salary banding structures. All positions will still be required to meet minimum recruitment standards as outlined by the North Carolina Office of State Human Resources.

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Will any positions be eliminated?

No, no positions will be eliminated as a direct result of this initiative.

What if my team has positions that do not align well with one of the 15 standardized positions?

The 15 standardized positions are meant to capture the majority of clinical research staff but are not fully comprehensive of all roles. For example, there are not standardized position descriptions for project managers and program directors. If an existing position does not align well with one of the 15 standardized positions, it will not be “mapped.”

For more information, please see the webpage and full list of FAQs.

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The ������ Health Office of Research Support and Compliance (ORSC) has a new SharePoint site! On the new site, you can review information about all of the ������ Health network partners, initiate a request to conduct research in collaboration with a network site, review policies and procedures for research conducted with network sites, and access additional information.

������ Health employees can access the SharePoint site directly at:

������ SOM employees with hospital credentials (i.e. a “U” number) can access the SharePoint site by logging into ������ Health Citrix (), then opening the Intranet app. Once ������ Health Intranet page is open, open a second tab in the same browser and paste the link into the address field: . Then login with your U number using the format: U99999@unch.unc.edu.

If you have questions about the content or suggestions for the site, please contact Diane Powers at Diane.Powers@unchealth.unc.edu.

Thank you,

SOM CRSO

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