ARTICLE I - NAME OF ENTITY

Section 1

The name of this entity shall be the University of Utah Clinical Research SOP Collaboration Group (“CRCG”).

ARTICLE II - PURPOSE

Section 1

The purpose of this entity is to create and maintain standard operating procedures (SOPs) for all clinical research conducted at the University of Utah. These SOP(s) are developed to ensure consistency in the conduct of critical research activities, adherence with Good Clinical Practice (GCP) guidelines, and compliance with federal, state, and local regulations common to all types of clinical research.

ARTICLE III - AUTHORITY

Section 1

This entity operates under the authority of the Office of the Associate Vice President for Research Integrity & Compliance and the direction of the Office of Quality Compliance (OQC).

Section 2

This entity will comply with all University of Utah policies and regulations.

Section 3

This entity may establish Standing Rules to govern administrative and procedural matters (such as time and location of meetings, etc.). Standing Rules shall not conflict with these bylaws. Standing Rules may be adopted, amended, or temporarily suspended by a majority vote of the membership.

ARTICLE IV - APPLICABILITY AND ADHERENCE

Section 1

The Clinical Research SOPs are applicable to all individuals that are conducting or contributing to the performance of clinical research at the University of Utah.

Section 2

Campus-wide adherence to all CRCG SOPs is expected and every effort should be made to adhere to the principles and processes outlined in these SOPs.

Section 3

Department/division SOPs that are of the same topic and similar processes should be retired, and the CRCG SOPs should be implemented.

Section 4

Department/division SOPs that are of a different topic can be utilized as long as they do not contain contradicting principles and processes to those established by the CRCG SOPs.

Section 5

If additional details or processes specific to an individual department/division are needed, Working Guidelines should be developed to supplement the CRCG SOPs. However, department/divisional Working Guidelines should not conflict with the SOPs in the CRCG library and should follow the same basic principles and standards.

Section 6

If an exception to an SOP is needed, a department/group may have SOPs that contain contradictory processes. In such rare instances, the department should document, in writing, what part of the SOP cannot be adhered to, the alternative process that will be followed, and why the alternative process is necessary for their department/group.

Before implementing any SOPs containing contradictory processes, the department/group should consult the CRCG regarding the alternate SOP.

ARTICLE V - MEMBERSHIP

Section 1

Membership will be comprised of qualified and experienced clinical research professionals working in compliance-related roles at the University of Utah—across both Health Sciences and Main campuses.

Section 2

Membership appointments are made by the Director of the Office of Quality Compliance.

Section 3

Members are responsible for actively contributing to the development of clinical research SOPs, including identifying SOP gaps/needs, drafting new content, updating and revising existing SOPs, and marketing/advertising SOP development to increase awareness and adherence to clinical research SOPs.

When it is determined that a new SOP, guidance or supplemental document, or revision to an existing document is required, a point person and subcommittee will be designated to lead the development or revision process. Once a draft has been prepared, it will be distributed to the full entity for review and feedback. The point person and subcommittee will be responsible for setting review timelines, incorporating feedback, and guiding the document through the review and revision process.

Section 4

The decision to develop and/or revise an SOP requires a majority vote (i.e., greater than 50%) of the voting membership in attendance at a regularly scheduled, ad hoc meeting, or by email/electronically. Voting membership shall consist of all elected officers as well as additional non-officer members as designated by the organization

Section 5

Non-members with special experience and/or knowledge may be invited to attend meetings in order to advise and/or contribute to the development of clinical research SOPs. This will occur on an as needed basis, as proposed by one or more of the appointed members and upon approval by the President of the CRCG.

Section 6

There shall be no dues or fees for membership in this entity.

Section 7

The CRCG and its members will comply with Interim Policy 1-012: University Non-discrimination Policy.

ARTICLE VI - OFFICERS

Section 1

The officers of the entity shall be the President, Chair, Administrator, Marketing/Communication Lead, and Finance Lead.

Section 2

In addition to the general membership responsibilities outlined in Section V, officers shall fulfill the specific duties and obligations associated with their respective positions, as defined in this section.

1. 1. The CRCG President shall:
      1. serve as chief executive officer
      2. preside at meetings (when in attendance)
      3. define official vision for the organization, representing the policies, views, opinions, and activities of the entity
      4. appoint members
      5. have further powers and duties as prescribed by the entity
   2. The Chair shall:
      1. prepare meeting agenda
      2. track searches performed on Google, Pulse, and other search platforms to identify University SOP needs for development
      3. preside at meetings when the President is not in attendance
      4. act as an official spokesperson, articulating vision, policies, views, opinions, and activities, as defined by the President
   3. The Administrator shall:
      1. take minutes at all meetings, and maintain minutes on file
      2. be responsible for filing/documenting internal and external correspondence
      3. maintain membership records
      4. monitor CRCG group email (crcg@utah.edu) and route/reply to emails, as appropriate and able
   4. The Marketing & Communication Lead shall:
      1. complete a quarterly update on the “Updates to Clinical Research SOPs” webpage
      2. notify University newsletter and blog partners of all new posts to the “Updates to Clinical Research SOPs” webpage
      3. update the listserv(s) quarterly
   5. The Finance Lead shall:
      1. lead development of CRCG SOP content relating to clinical research fees, budget creation, and analysis (“finance”)
      2. ensure that all CRCG SOP finance content is compliant with all applicable regulations and policies
      3. perform annual review of all CRCG finance SOPs
      4. oversee all University communications relating to finance standards and procedures established by CRCG SOPs

ARTICLE VII - SELECTION OF OFFICERS

Section 1

The office of the CRCG President is a non-elected position occupied by the Director of the Office of Quality Compliance (OQC).

Section 2

Remaining officers will be nominated from the roster of current members. Members may nominate themselves or another member for an office.

Section 3

The officers shall be elected in this order: Chair, Administrator, Marketing/Communication Lead, and Finance Lead.

Section 4

Officers will be elected at the first regularly scheduled meeting following the completion of a term.

Section 5

Nominations for officers shall be made at the last regular meeting immediately preceding the completion of a term.

Section 6

Officers shall be elected by majority vote of the voting membership participating in the election, as defined in Section 4 of this article.

Section 7

Votes shall be cast by secret ballot; however, when there is only one candidate for an office, a motion may be made to elect the candidate by acclamation.

Section 8

Officers shall assume the elected office following the election meeting, and shall serve a term of three (3) years. Officers can renew their service for additional terms by vote.

Section 9

No member may hold more than one office.

Section 10

If any officer position becomes vacant, the position shall be filled by election and the newly appointed officer will be announced at the next regularly scheduled meeting after the vacancy was announced. Nominations may be made at the meeting where the vacancy is announced, from the floor at the time of the election, or remotely through electronic election processes (i.e. Zoom, Teams, election program, email, etc.). The President may appoint an interim officer to fill the vacancy until the election is held.

ARTICLE VIII - MEETINGS

Section 1

Regular meetings shall be scheduled bi-monthly (i.e., once every two months).

Section 2

Business cannot be conducted unless a quorum of the membership is present/represented. A quorum is defined as one-third of the voting membership. See Article V, Section 4 for details.

Section 3

 Absentee or proxy voting is not permitted.

ARTICLE IX - AD HOC BUSINESS

Section 1

SOP development between regular meetings may necessitate decisions be made by electronic correspondence (i.e., email).

Section 2

Email correspondence must include all voting members.

Section 3

Decisions about SOP development will require a majority vote, as defined in Article 3, Section 3.

ARTICLE X - REVIEWING AUTHORITY

Section 1

Following the development of a new SOP, guidance or supplemental document, or revisions to existing documents, this entity will review the content and proceed with a vote for approval. See article V for more details on voting membership and approval requirements.

Section 2

Once this entity has voted to approve a new document or revisions to an existing one, the draft documents may be shared with relevant institutional compliance groups (e.g. the Office of Quality Compliance and Clinical Research Support Office) for additional review and, where appropriate, approval. The final draft will be submitted for central institutional review by the Associate Dean for Clinical Research. Depending on the nature of the edits or feedback received from the aforementioned reviewers, this entity may require an .

Section 3

The Vice President for Research (VPR) holds final review and signing authority. All finalized documents requiring signature will be submitted to the VPR upon completion of the review and approval processes outlined in Sections 1 and 2.

ARTICLE XI - AMENDMENTS TO BYLAWS

Section 1

Proposed amendments to these bylaws shall be presented, in writing, to the administrator. The administrator shall share the proposed revisions with the CRCG officers. The CRCG officers will review and make recommendations on all bylaw revisions prior to consideration by the membership body.

Section 2

Bylaw amendments require majority approval (i.e., greater than 50%) of the voting members present at a regular meeting. The amendment shall be effective immediately unless otherwise stipulated in the amendment.