STANDARD OPERATING PROCEDURE Inset Department

SOP No: Insert No

SOP Title: Generation, Issue and Control of SOPs

SOP Number Insert Number

SOP Title Generation, Issue and Control of Standard Operating Procedures

NAME TITLE SIGNATURE DATE

Author

Reviewer

Authoriser

Effective Date:

READ BY

NAME TITLE SIGNATURE DATE

Adapted from CTRG Template SOP Version 3.1

© Copyright: The University of Oxford 2009

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STANDARD OPERATING PROCEDURE Inset Department
SOP No: Insert No
SOP Title: Generation, Issue and Control of SOPs

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 Name of 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

4.1 Standard Operating Procedures (SOPs)

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

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

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

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

4.5 All Staff

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

Adapted from CTRG Template SOP Version 3.1

© Copyright: The University of Oxford 2009

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STANDARD OPERATING PROCEDURE Inset Department
SOP No: Insert No
SOP Title: Generation, Issue and Control of SOPs

5. RESPONSIBILITIES

5.1 Author
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.

5.2 Reviewer
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.

5.3 Authoriser
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

6.1 Identification 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.

6.2 Numbering 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.

6.3 SOP 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.

6.4 Content
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.
Adapted from CTRG Template SOP Version 3.1
© Copyright: The University of Oxford 2009

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STANDARD OPERATING PROCEDURE Inset Department
SOP No: Insert No
SOP Title: Generation, Issue and Control of SOPs

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.

6.5 Issue 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.

6.6 SOP 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.

6.7 Routine 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.

8.1 Internal References

8.2 External References

9. CHANGE HISTORY
Where the SOP is the initial version:
 The SOP number is recorded.
 “Initial version” is noted in the ‘Significant’ section.
Adapted from CTRG Template SOP Version 3.1
© Copyright: The University of Oxford 2009

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STANDARD OPERATING PROCEDURE Inset Department
SOP No: Insert No
SOP Title: Generation, Issue and Control of SOPs

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).

Effective Previous
SOP no. Significant Changes
Date SOP no.

Adapted from CTRG Template SOP Version 3.1

© Copyright: The University of Oxford 2009

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