North Shore – LIJ Health System, Inc.

<Enter name of clinical trial site>

SOP TITLE: STANDARD OPERATING PROCEDURE FOR CLINICAL TRIAL SITES
SOP #: <Enter SOP number>
Approval Date: <Enterdate the SOP is approved by local leadership.>
Site Implementation Date:<Enterdate the SOP is implemented at individual clinical trial site.>
Prepared by: <Enter name of author of the SOP.>
Last Revised:<Enterdate last version of the SOP was reviewed and approved.>
Effective Date:<Enterdate the SOP was first created and approved.>

OBJECTIVE:

The objective of this Standard Operating Procedure (SOP) is todescribe the standard requirements and method for the writing and maintaining SOPs forsites conducting clinicaltrials at or on behalf of North Shore-LIJ Health System (health system).

SOPs are uniformly written procedures, with detailed instructions to record routine operations, processes and practices.Clinical trialSOPs define the research site’s standard practices and daily processes conducted to assure execution of clinical trial tasks in accordance with institutional, state and federal guidance, regulations, and policies.SOPs should contain adequate detail to clearly guide clinical trial staff through a particular procedure and thereby establish uniformity in the everyday clinical trial functions.

RESPONSIBILITIES:

  • The Principal Investigator (PI), or his/her designee(s), is responsible for writing, implementing,maintaining, and ensuring compliance with site/department/facility specific clinical trial SOPs.

PROCEDURES:

Steps for Writing a SOP

  • A clinical trial activity is identified as needing a SOP.
  • The writer prepares a step-by-step task listing of all the procedures needed to be conducted for thecompletion of the activity, including who (by title - not name) will perform each task.
  • The step-by-step tasks for the activity are evaluated for efficiency, effectiveness, and compliance with FDA regulations, guidelines, ICH (E-6) GCPs and institutional policies.
  • If applicable, tools are designed to be used with the SOP such as forms, templates, checklists, etc.
  • After the first draft of SOP is completed, it is reviewed and practiced for accuracy and ability to follow.
  • After the step-by-step tasks of all the procedures are tested, all comments and revisions are evaluated and are included in the final version as appropriate.
  • The final version of the SOP is approved in accordance with local leadership approval process.

SOP Information

All clinicaltrial SOPs must include the following information.The attached sample SOP template or any similar document that includes the following information can be used. SOPs should be written in a uniform manner. A standard format should be followed with consistent font size, unit title, and section headers.

  • SOP Title
  • SOP #
  • Approval Date: Date the SOP is approved by local leadership.
  • Site Implementation Date: Date the SOP is implemented at individual site/department/facility/clinical trial area.
  • Prepared by: Writer of the SOP.
  • Last Revised: Date last version of the SOP was reviewed and approved.
  • Effective Date: Date the SOP was first created and approved.
  • Objective: The writer describes the objective and purpose of the SOP.
  • References: This section notes why the activity is being performed. For example, the activity may be performed in order to meet federal regulations or North Shore-LIJ Health System policy. The writer should reference applicable regulations and/or other related policies or SOPs.
  • Responsibilities: The writer lists the people who are responsible for the oversight of the SOP, performing the activities, or other procedure responsibilities.
  • Procedures: The writer describes the tasks or step-by-step procedures necessary for completion of the activity.
  • Appendix: The writer attaches reference materials such as forms, checklists, or other additional information in this section.
  • Signatures: The SOP must include dated signatures of the writer and approvers. Their printed name and title should also be included.
  • Footer: The Footer will include the SOP #, the latest approval date and page X of Y, with Y being the total number of pages.

Implementation

  • After the SOP is final and approved, the writer distributes copies (electronic or paper copy) to all pertinent individuals and provides education to all appropriate staff.
  • Documentation is kept on staff education, including information on SOP title, SOP #, method of education, date of education, staff name/title.
  • As each SOP is newly implemented or revised, staff education is conducted to ensure understanding of the requirements of the SOP, and the activities necessary for adherence to the SOP.
  • The Investigator ensures that the site procedures, and activities detailed in the SOP, accurately reflect how the tasks are performed at the site.

SOP revisions

  • Each SOP is reviewed as needed, and at a minimum of every 2 years, for possible revisions due to changes in regulations or site procedures.
  • Each revision is labeled with the date last revised and approval date.
  • A copy of the revised SOP is sent to applicable staff members to replace their copy of the previous version of the SOP.
  • A central records area must maintain all old versions of SOPs. In the event of a regulatory audit, the auditor may audit a study against the SOP that was in effect at the time of study conduct.

APPENDIX:

  • Sample SOP Template

REFERENCES:

  • NSLIJHS policy GR095: Requirements of SOPs for Clinical Trial Sites.

Author: Date: ____/____/____

<Insert Name and Title>

Approved: Date: ____/____/____

<Insert Name and Title>

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