OP005 - Procedure for Creating and Changing SOPs

OP005 Procedure for Creating and Changing SOPs
Review Committee: Planning Effective Date: 11/04/2011
Attachments: Revised Date: 6/12/2015
Forms: Reviewed Date: 7/16/2024

Introduction:

The Standard Operating Procedure (SOP) Manual was created to implement Traumatic Brain Injury Model Systems (TBIMS) policies and procedures using a formal approach. SOPs must be developed, changed, and finalized using the specific procedural steps outlined below.

Purpose:

To establish a formal method to develop, change, and finalize a Standard Operating Procedure (SOP).

Scope:

The TBIMS Centers and the National Data and Statistical Center (NDSC).

Responsibilities:

Staff of the TBIMS Centers and the NDSC must abide by this procedure.

Procedural steps:

Creating a New SOP:

  1. The NDSC coordinates the administrative aspects of developing new SOPs.

  2. A New SOP must originate from either the NDSC or a specific TBIMS Committee (Executive, Planning, Data, Knowledge Translation, or Research) which will complete the SOP template available at the NDSC.

  3. Once the SOP template is completed in draft form, it needs a majority approval by the originating committee members. If the SOP originates from the NDSC it still must go through an originating committee before advancing ahead in the SOP process.

  4. Once approved by the originating committee the SOP goes to the Planning Committee and to NIDILRR for additional vetting. All edits and contextual changes will be taken into consideration during this stage and tracked using MS Word track changes.

  5. After approval by majority vote is received from the Planning Committee the SOP goes into effect on the effective date displayed in the header and will be posted to the NDSC web-site.

  6. The group where the SOP originated will review the SOP on its normal schedule (listed at the bottom of the SOP).

Making Changes to Existing SOPs:

  1. The NDSC will coordinate the administrative aspects of changing existing SOPs.

  2. If an SOP is to be revised it goes to the TBIMS committee from where it originated. [Note: Any SOP without an originating committee will be assigned to a committee by the Executive Committee].

  3. Once the SOP has been revised and receives a majority vote by the originating committee the SOP along with a short paragraph outlining the contextual changes to the SOP is sent to the Planning Committee and to NIDILRR for additional vetting. All edits and contextual changes will be taken into consideration during this stage and tracked using MS Word track changes.

  4. After approval by majority vote is received from the Planning Committee the SOP goes into effect on the effective date displayed in the header and will be posted to the NDSC web-site.

  5. The group where the SOP originated will review the SOP on its normal schedule (listed at the bottom of the SOP).

Training requirements:

None

Compliance:

Staff of the TBIMS centers and the NDSC must comply with this procedure.

References:

None

History:

Date Action
11/4/2011 SOP developed by the NDSC
5/15/2012 The form “SOP Review Committees” was listed as an attachment
1/1/2013 “Review Committee” was added to the heading. Review Committee Attachment deleted
4/16/2015 Updated “Dissemination” to “Knowledge Translation”
6/12/2015 Updated NIDRR to NIDILRR
7/16/2024 SOP reviewed

Review schedule:

At least every 5 years.