SOP No: Insert No.
SOP Title: Study Protocol Development and Review
SOP Number / Insert No.
SOP Title / Study Protocol Development and Review
NAME / SIGNATURE / DATE
Author
Reviewer
Authorised by
Effective Date:
READ BY
NAME / TITLE / SIGNATURE / DATE
Adapted from CTRG Template SOP version 2.2
The University of Oxford 2009
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STANDARD OPERATING PROCEDURE / Insert DepartmentSOP No: Insert Number
SOP Title: Study Protocol Development and Review
This SOP template 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 standard procedures to be followed when developing and reviewing a protocol for clinical trials sponsored by the University of Oxford.
2. introduction
The ICH Harmonised Tripartite Guideline for Good Clinical Practice states that clinical trials must be scientifically sound and described in a clear, detailed protocol. The contents/topics of the protocol are also defined in section 6 of the ICH GCP Guideline.
3. Scope
This SOP applies to clinical trials where the University of Oxford has accepted the role of ‘Sponsor’ in the INSERT NAME department/ for the INSERT NAME/NUMBER trial.*
* delete as appropriate
This SOP does not apply to commercially funded research or research sponsored by an external non-commercial organization.
4. responsibilities
4.1 Chief Investigator or delegate
To prepare a study protocol and related documents and gain the necessary approvals to conduct the study.
4.2 Clinical Trials and Research Governance (CTRG)
To provide advice/assistance with the preparation of the protocol and related documents, as necessary. To review the documents for GCP compliance.
5. SPECIFIC procedure
5.1 Planning
The author of the protocol will identify individuals with relevant experience to contribute to the protocol eg. provide statistical input, pharmacy information, review the protocol. Review of the protocol must include peer review according to the UK Department of Health Research Governance Framework which states that ‘Every proposal for health and social care research must be subjected to review by experts in the relevant fields able to offer independent advice on its quality’. Documentation of peer review should be filed. The protocol should also be reviewed by Clinical Trials and Research Governance for GCP compliance.
5.2 Version Control
The following gives an example of how version control could be handled. Amend as necessary to follow conventions within your department.
The first draft of the protocol should be labelled ‘Draft version 0.1’ and dated. Further draft versions should be labelled ‘Draft version 0.2, 0.3’ etc and dated.
Once a final version of the protocol has been produced, it should be labelled ‘Final Version 1.0’ and dated. This version will be submitted for the appropriate approvals. If amendments are necessary following review of the protocol by the Ethics Committee or MHRA then subsequent versions of the protocol should be labelled ‘Final Version 1.1, 1.2’ whilst being drafted and reviewed and the version re-submitted for approval should be labelled ‘Final Version 2.0’ and dated.
If the protocol is then amended again during the study then the version submitted for approval of the amendment will be labelled ‘Final Version 3.0’ and so on.
5.3 Production and Review of Protocol
All protocols must meet a standard that adheres to the ICH principles of GCP prior to submitting to the Independent Ethics Committee (IEC) or the Competent Authority (CA
The protocol should be as detailed as possible. It should include all the necessary reference numbers e.g. ethics reference number and the EudraCT number (for studies in the EU). Go to http://www.admin.ox.ac.uk/rso/clinical/ to download a GCP compliant protocol template.
After preparation the first draft of the protocol should be circulated to the reviewers (including CTRG for GCP review, allowing 5 working days for review) and a deadline given for response.
Once comments have been received from all reviewers, the author should ensure that all points have been incorporated or discussed further with the reviewer to resolve them. The process of review and revision should be repeated as necessary.
It may be useful to keep electronic copies of all draft and final versions of the protocol together with review comments for future reference.
In parallel with finalising the protocol, it will be necessary to prepare all other required trial documents such as subject information sheets and informed consent forms. Detailed guidelines for preparation of information sheets and consent forms can be found on the UK National Research Ethics Service (NRES) website.
If advertisements or standard letters to the subject’s GP are required for the study, these should also be prepared.
Once the protocol and all other relevant documentation has been finalised, applications should be made to the Ethics Committee (see SOP ..), MHRA for studies in the UK (see SOP ..) and relevant host organisation office e.g. NHS Trust R&D office. The protocol should also be registered for publication (see SOP ..).
5.4 Approval and Distribution of Protocol
Once the necessary approvals have been obtained for the study, the protocol signature page should be signed by the Chief Investigator and all key collaborators (as applicable) prior to the start of the study.
5.5 Protocol Amendments
See SOP… for details of the procedures to be followed in the case of a protocol amendment following approval of the study.
6. forms/templates to be used
Where Forms/Templates are referenced in the text, the numbers and titles are listed under this section.
7. 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.
7.1 Internal References
Insert relevant internal SOPs
7.2 External References
ICH Harmonised Tripartite Guideline for Good Clinical Practice.
Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of medicinal products for human use.
UK Department of Health Research Governance Framework for Health and Social Care. Second Edition 2005.
Add as required
8. Change History
Where the SOP is the initial version:
· SOP No: Record the SOP and version number
· Effective Date: Record effective date of the SOP or “see page 1”
· Significant Changes: State, “Initial version” or “new SOP”
· Previous SOP no.: State “NA”.
Where replacing a previous SOP:
· SOP No: Record the SOP and new version number
· Effective Date: Record effective date of the SOP or “see page 1”
· Significant Changes: Record the main changes from previous SOP
· Previous SOP no.: Record SOP and previous version number
SOP no. / EffectiveDate / Significant Changes / Previous
SOP no. /
Adapted from CTRG Template SOP version 2.2
The University of Oxford 2009
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