Adapted from CTRG Template SOP Version 3.1

Adapted from CTRG Template SOP Version 3.1

© Copyright: The University of Oxford 2009

Page 1 of 5

This SOP has been written as an example which can be adapted for use in any department conducting clinical research where there are no SOPs in place. The contents of the SOP should be reviewed in conjunction with the procedures which take place within the department and the text should be altered accordingly.

Delete highlighted text before finalising the document.

1.purpose

The purpose of this Standard Operating Procedure (SOP) is to describe the procedures for generation, issue and control of SOPs.

2.introduction

SOPs are documents which describe the procedures that should be followed in order to achieve uniformity in the performance of specific functions. They should be designed to give guidance in a clear and concise manner and should be agreed and adopted by those for whom they are produced.

3.Scope

This SOP relates to SOPs produced by the INSERT Nameof department/ for the INSERT name/number of trial/study (delete as appropriate) in relation to the management of clinical research sponsored by the University of Oxford.

This SOP does not apply to commercially sponsored research or research sponsored by an external non-commercial organisation.

4.Definitions

4.1Standard Operating Procedures (SOPs)

Detailed, written instructions to achieve uniformity of the performance of a specific function.

4.2Author

Any person who is familiar with the activity covered by the SOP, and who is competent to carry it out.

4.3Reviewer

A person who is appropriately qualified or experienced to review the procedure covered by the SOP.

4.4Authoriser

The head of the department (or equivalent) to which the SOP relates

4.5All Staff

All affected staff should review procedures during use of the SOP and provide comments to the Author of any changes required.

5.RESPONSIBILITIES

5.1Author

Generates and revises the SOP.

Identifies and ensures that the appropriate individuals review the SOP.

Ensures that comments are incorporated into the SOP if appropriate.

Ensures that SOP is finalised, approved and signed off by relevant individuals.

Receives comments from users of the SOP and assesses the need for revision.

5.2Reviewer

Provides input into the SOP as an expert. The Reviewer can also be an Authoriser.

Signs the SOP to document that it has been reviewed by an appropriate expert.

5.3Authoriser

Ensures that all procedures in the SOP are documented accurately and according to current practices. The Authoriser can also be a Reviewer.

Authorises the SOP.

6.Specific Procedure

6.1Identification of Need

Any member of staff may identify procedures that should be covered by an SOP.

The head of department (or equivalent) should be informed and an author identified.

The SOP will be allocated a reference number and title. These details will be added to the list of SOPs and marked as being in draft form.

6.2Numbering convention

SOPs should be numbered as follows:

Explain as appropriate e.g. An abbreviation of the topic covered e.g. CR for clinical research, followed by a number starting from 001, followed by a version number starting from V1. In the above example the first SOP for clinical research would have the SOP number: CR-001-V1.

6.3SOP Generation

The author will take on ownership of the SOP. This includes writing, identifying reviewers, ensuring timely review and addressing any comments produced by the review process.

Any unresolved discrepancies should be related to the authoriser for resolution.

6.4Content

Further details for the content of the SOP sections are to be found in the SOP Template.

The SOP should be written clearly and concisely, avoiding repetition. All abbreviations and acronyms should be defined.

Wherever reference is made to an activity covered by another SOP, the instruction “see SOP entitled xxx” should be inserted. The version number may be excluded if an SOP is referenced in another SOP.

6.5Issue of SOP

Once the final version of the SOP has been produced it will be authorised and the effective date as well as expiry date entered on the cover. This date will be agreed with the head of department (or equivalent), and should reflect the need for the SOP and allow time for training on the SOP. The signed version should be filed in the department and may be scanned and filed in the department electronic filing system.

The SOP will be amended to record the SOP as finalised.

6.6SOP Training

Before implementation of a SOP, relevant training should be given to affected personnel and documented in their training record. The author and head of department (or equivalent) should identify which personnel require training.

6.7Routine Review of issued SOPs

A routine review of each SOP should be carried out at least annually, unless earlier review becomes necessary through the introduction of new regulations or procedures.

The outcome of the review process will be recorded on the SOP. This may be that no revision is necessary; that amendment and revision is necessary; or that the SOP has become obsolete.

Where the SOP has been revised, the reason for the revision will be recorded.

7.forms / templates to be used

Where Forms/Templates are referenced in the text, the numbers and titles are listed under this section.

Standard Operating Procedure Template

8.internal and external references

This section is used to list all controlled internal references (e.g. SOPs) and external references referred to within the text of the SOP only.

8.1Internal References

8.2External References

9.Change History

Where the SOP is the initial version:

• The SOP number is recorded.
• “Initial version” is noted in the ‘Significant’ section.

Where replacing a previous SOP:

• The Effective Date for the previous version is recorded against that version in the table.
• Record the new SOP number; record the Effective Date as “See page 1”.
• Main changes from the previous SOP(s) are listed under ‘Reason for Replacement’, in sufficient detail to provide guidance for training.
• If the SOP replaces a previous version or another procedure, the SOP number for the document is listed in the ‘Previous SOP No.’ column (see section 12 of this SOP for an example).

Adapted from CTRG Template SOP Version 3.1

© Copyright: The University of Oxford 2009

Page 1 of 5