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Ohio University Heritage College of Osteopathic Medicine
Heritage Hall, Athens, OH 45701
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106 CTRU Operational Closure Procedures

Document Name:
CTRU Operational Closure Procedures		Document Number:
106		Revision Date:
11JUN2024		Supersedes:
201.00
Target Group:
Research Personnel		Approval Date:
22NOV2024		Effective Date:
22DEC2024		Training Required:
None

Purpose

To ensure the Principal Investigator (PI) and all research team members assisting with the conduct of clinical research at the Ohio University Heritage College of Osteopathic Medicine’s Clinical and Translational Research Unit (CTRU) are informed about their obligations and responsibilities as they pertain to Good Clinical Practices (GCP), the investigational plan, applicable regulations, and institutional policies.

This Standard Operating Procedure (SOP) describes CTRU interactions with the Sponsor or Contract Research Organization (CRO). This procedure is intended to meet Food & Drug Administration (FDA) federal regulations and Good Clinical Practices (GCP) in the event of an emergency closure or inclement weather emergency and in accordance with federal, state, and institutional standards.

Responsibilities

The CTRU is responsible for developing, implementing, and maintaining SOPs. Creating new or revising an existing SOP is determined by changes to federal regulations, guidelines, institutional policies, or procedures. All applicable documents will be provided to departments and research teams conducting human subject research.

Policy

The CTRU is not staffed on days Ohio University is closed. No study staffing will be provided if a study visit is scheduled on an observed holiday. However, study visits that use the space and do not require CTRU staff may occur with prior notification to the Director of the CTRU.

In the event of inclement weather when the university remains open, all CTRU staff are expected to make every reasonable effort to maintain their regular work schedules but are advised to avoid undue risks in traveling.

Definitions

Snow Levels:

  • Pursuant to Ohio Attorney General Opinion 86-023, “The Sheriff of a County may declare a Snow Emergency and temporarily close County and Township Roads within his jurisdiction for the preservation of the public peace.”
  • Attorney General Opinion 97-015 allows the Sheriff to close State and Municipal Roads.
  • Wintry conditions are classified as one of the following three (3) levels:
    • LEVEL 1: Roadways are hazardous with blowing and drifting snow. Roads are also icy, drive carefully.
    • LEVEL 2: Roadways are hazardous with blowing and drifting snow. Only those who feel it is necessary to drive should be out on the roadways. Contact your employer to see if you should report to work.
    • LEVEL 3: All roadways are closed to non-emergency personnel. No one should be out during these conditions unless it is absolutely necessary to travel. All employees should contact their employer to see if they should report to work. Those traveling on the roadways may subject themselves to arrest. 

Procedures

1. University Holiday Procedure

  • The university observes the holidays on the dates listed on the Ohio University website: https://www.ohio.edu/hr/benefits/holiday-schedule.
  • If a PI would like to use the CTRU facility during an observed holiday, the PI must notify the assigned research coordinator and/or the Director of the CTRU.
  • Staff are not required to work on observed holidays.

2. Inclement Weather Procedure

  • Please use caution and personal discretion to determine safety when reporting to work. The OHIO alert system will provide updates regarding the University's closing, early release, or delay.
  • Should the University delay, release early, or close, staff are accountable for designated study responsibilities (i.e., rescheduling participant visits, monitoring visits, or managing other study duties).

3. Emergency Closing Procedure

  • The university operates under normal conditions during typical seasonal inclement weather unless an emergency closure, early release, or delay has been declared, as outlined in Policy 40.051. If the university closes, the CTRU will also close. Each individual should make travel decisions based on the prevailing weather conditions.
  • Notification of campus closure will be prominently displayed on the Ohio University main website, http://www.ohio.edu or through the OHIO alert system.
  • If an evacuation of the campus is necessary, all personnel will be expected to assist in helping students, faculty, staff, and others to leave the campus.

4. Communication Procedure

  • Each CTRU staff member will stay aware of the potential for inclement weather and manage research visits, monitoring visits, and other assigned responsibilities. Examples of preparation could include but are not limited to the following:
    • Reviewing their calendar before the anticipated weather to make alternative arrangements with scheduled participant visits.
    • Communicating via phone, email, or other approved protocol methods with participants, monitors, etc., to facilitate a backup plan as needed.
  • In the event of inclement weather, emergency closure, or an event preventing a CTRU staff member from reporting to work as scheduled, the following procedure should be completed:
    • If a study visit occurs, the CTRU staff member will contact their immediate supervisor and the study PI.
    • Notify the CTRU team of their absence and arrange alternative coverage if possible.
  • Events may occur when a CTRU team member experiences an unexpected absence or delayed arrival. CTRU team members will communicate with another team member as soon as possible to coordinate and provide backup in their absence. If it is not possible to identify a backup, the study PI will be notified.

Applicable Regulations, Guidance, and Policies

RegulationTitle
21 CFR 50Protection of Human Subjects
21 CFR 312Investigational New Drug Application 
21 CFR 812Investigational Device Exemptions 
45 CFR 46Protection of Human Subjects
ICH E6(R2)Guideline for Good Clinical Practice E6 Integrated Addendum
FDA Guidance for IndustryInvestigator Responsibilities – Protecting the Rights, Safety, and Welfare of Study Subjects, October 2009 
Ohio Attorney General Opinion 86-023 and 97-015 Ohio Committee for Severe Weather Awareness
Ohio University Campus Emergency Response Ohio University Campus Emergency Guide
Ohio University Policy 40.051 40.051: Declaring an Emergency Closure, Early Release, or Delay

References: None

Appendices: None

Approver: Director, CTRU and Clinical Partnerships