SOP for Creation, Implementation and Revision of Standard Operating Procedures

Purpose

To document the procedure for the creation and implementation of new National Standard Operating Procedures (SOPs) and review of existing SOPs.

Scope

This SOP applies to any individual delegated the task of writing, reviewing, approving or distributing a clinical research SOP on behalf of an organisation. This applies in all instances when a need is identified to either create a new SOP or modify an existing one. Authors of SOPs should have experience of the area covered by the SOP and be authorized to create or modify these.

Procedure

Initiating the creation of a new SOP or revision of an existing SOP

All persons engaged in clinical research may:

• Identify the need for a new SOP or a deficiency or an improvement in an existing SOP and suggest appropriate modification.
• Notify the jurisdictional health department (or equivalent) and discuss this need with the SOP number and title in the subject header.

The CTPRG (or its successor) and/or NMA members will delegate a responsible jurisdiction to coordinate the following steps in the creation of a new or revision of an existing SOP, and in seeking national endorsement across all jurisdictions:

• Actively invite feedback from all users, jurisdictions and interested stakeholders, to inform a regular, formal review of the SOP and to enable a continuous improvement approach.

1. At a minimum, this should be undertaken at least every two years following approval and release of the SOP (including where there may be subsequent revisions to the SOP in future).
2. A clear mechanism for feedback must be established and advertised widely in advance of the formal review period, to ensure all users, jurisdictions and interested stakeholders have adequate opportunity to contribute to the review process. This will include publication on relevant jurisdictional websites of a notice that a formal review of the SOP will be undertaken. The notice will include details of relevant email addresses through which feedback and suggestions for amendment and/or enhancement of the SOPs can be submitted, as well as timeframes of the review and submissions period.

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• Assess and verify the need for a new or revised SOP.
• Use the provided template in Annexure-1 and assign a document ID number and Version date for all new SOPs or to modify an existing SOP.
• Draft the new or modify existing SOP and distribute to relevant stakeholders for review and comment.
• Maintain a record of the review process either on a document tracking review log (including at a minimum the SOP ID, version number, reviewer name, review date, changes and comments noted by reviewer, action by owner, date of action, new version) or electronically by using the tracked changes feature with a file naming paradigm and save files on central drive.
• Incorporate relevant comments and if required redistribute to relevant stakeholders for second review.
• If necessary, repeat the above 2 steps (dot point 4 and 5) until a final version is ready for approval.
• Update the front-page identifier box and/or amend history box as necessary, ensuring the ‘SOP effective date’ and ‘SOP review by date’ is in alignment with the timeframe identified in this SOP.

Approval and Authorisation of the SOP

CTPRG (or its successor) and/or NMA members will:

• Print the final SOP and arrange for approval, authorization and final sign off by the CTPRG (or its successor) and all jurisdictional health departments and signatories to the National Mutual Acceptance (NMA) Memorandum of Understanding.
• Ensure the original signature field and/or amendment history field is completed by the delegated coordinating jurisdiction.
• File the final approved (in writing) new/amended SOP electronically as a pdf document and distribute to all jurisdictional members to post on their websites.
• Securely store the final, approved, new/amended master SOP.
• Any changes to the approved National Standard Operating Procedures for Clinical Trials can only be made following the steps outlined in this SOP.

Training, Implementation, Distribution of the New or Revised SOP

• All relevant jurisdictional stakeholders must be notified of the new/updated SOP between the authorization and the effective date. This would include Health Services Human Research Ethics Committees (HRECs) and Research Governance Officers (RGOs).
• Training is to be recorded as per SOP, Site Staff Qualifications, Training Records and Capability.

Review

• The review date is two years after the effective date. The time between SOP authorization and the effective date may be reduced in special circumstances (e.g. urgent situations where procedures must be implemented immediately).
• An earlier review date is permitted where necessary (e.g. changes to legislation, changes to NMA policy and procedures).

Superseded SOPs

• All jurisdictional health departments and NMA jurisdictions, on behalf of the CTPRG, will notify relevant stakeholders including all HRECs and RGOs of superseded SOPs.
• The superseded SOP will be watermarked with SUPERCEDED and filed.
• The superseded hard copy master SOP will be clearly marked as superseded and be securely stored as a record of previously used SOPs.

Annexure

Annexure-1: SOP Template

Revision History

Nil

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