Corporate Compliance
Policy Title: [ADD TITLE] |
Compliance Policies and Procedures |
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Policy #: [NUMBER] |
Category: Compliance and Ethics |
Corporate Approval Date: [DATE] Local Site Implementation Date: [DATE] |
Effective Date: [COPY FROM PREVIOUS VERSION (if applicable)] Last Reviewed/Approved: [LAST APPROVAL DATE] |
Policy Owner: [DEPARTMENT NAME OR POSITION TITLE] |
Notations: |
Scope:
Purpose:
Policy:
Definitions:
Policy Section 1:
Policy Section 2:
Responsibilities:
Procedures:
References to Regulations and Other Related Policies:
Attachments and Work Tools:
Forms:
Footer:
Standardized Versioning History:
Instructions for Completing the Template
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The approved font is [fill in standard font and type size used for policies].
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All fields within the template need to be completed. If there is no information for that section, input N/A.
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Policy Title: Name of Policy.
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Policy Number: All new policy numbers are assigned by Corporate Compliance Office; existing policy numbers are carried over with policy revisions.
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Corporate Approval Date: Date approved by Compliance Committee.
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Local Site Implementation Date: This date is the date the policy is implemented at the local facility or site.
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Effective Date: Date policy first effective.
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Last Reviewed/Approved: Date of the last time the policy was confirmed and/or updated.
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Policy Owner: Name of person/committee/department that prepared the policy.
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Notations: Note any policy or policies merged into current version and/or policies to be archived and any other applicable notations, including sites/departments where policy may not be applicable.
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Scope: Clearly state to whom the policy applies and those to whom it may not apply, if any.
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Purpose: Overview/intent of the policy.
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Definitions: The definitions of any terms specific to this policy.
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Policy: The specific policy statements as stated in the regulations or defined by the policy owner.
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Responsibilities: Details of the specific responsibilities of persons within the organization by role (e.g., the responsibility of the policy owner, the compliance officer, other employees).
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Procedures: An outline of any specific steps/items to be followed or performed in implementing this specific policy.
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References to Regulations and Other Related Policies: A listing of the actual regulation, including regulatory agency and regulation number and/or policy number where applicable. These are listed only as necessary. Do not link to any other policy directly. If you are referring to another company policy, include a link to the internal system or site where the policy is available. Include a listing of clinical documents that have either background information or have a direct connection to the policy. These are listed only as necessary.
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Attachments and Work Tools: Include any flow charts, decision trees, or other work tools that aid in understanding of the policy.
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Forms: List all forms/numbers referenced in the policy. Include internal link to forms as applicable.
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Footer: The Footer will include the policy number; the latest approval date; “page X of Y,” with Y being the total number of pages; and the versioning history.
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Standardized Versioning History: Within the footer, include previous system approval dates.
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All previously approved/older versions must be stored in the policy management system.