STANDARD OPERATING PROCEDURE

Insert Department
SOP No: Insert Number

Draft SOP Title: Qualification, Experience and Training of Clinical Research

Personnel

SOP Number

Insert Number

SOP Title

Qualification, Experience and Training of Clinical Research Personnel

NAME

TITLE

SIGNATURE

DATE

Author
Reviewer
Authoriser

Effective Date:

READ BY
NAME

TITLE

SIGNATURE

Adapted from CTRG Template SOP version 3.1

Copyright: The University of Oxford 2009

Page 1 of 4

DATE

STANDARD OPERATING PROCEDURE

Insert Department
SOP No: Insert Number

Draft SOP Title: Qualification, Experience and Training of Clinical Research

Personnel
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 related to qualification, experience and training of personnel involved in
clinical research sponsored by the University of Oxford.

2.

INTRODUCTION
The ICH Harmonised Tripartite Guideline for Good Clinical Practice states that
investigators should be qualified by education, training and experience to assume
responsibility for the proper conduct of the trial, should meet all the qualifications
specified by applicable regulatory requirement(s), and should provide evidence of
such qualifications through up to date curriculum vitae (CV) and/or other relevant
documentation requested by the sponsor, the ethics committee, and/or the regulatory
authority(ies).
The Research Governance Framework for Health and Social Care, 2nd edition, 2005
states that each member of the research team, including those at collaborating sites,
is qualified by education, training and experience to discharge his/her role in the
study, and their qualifications are documented. It also states that it is the sponsors
responsibility to be satisfied that the chief investigator and other key researchers,
including those at collaborating sites, have the necessary expertise and experience
and have access to resources needed to conduct the proposed study successfully.

3.

SCOPE
This SOP applies to clinical research 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 organisation.

4.

RESPONSIBILITIES

4.1

Chief Investigator (CI) /Principal Investigator (PI)

The CI/PI is responsible to ensure that each individual involved in conducting clinical
research should be qualified by education, training and experience to perform his or
her respective task (s) and the qualifications are documented in CVs or other training
record filed in the Trial Master File/ department training file.

Adapted from CTRG Template SOP version 3.1

Copyright: The University of Oxford 2009

Page 2 of 4

STANDARD OPERATING PROCEDURE

Insert Department
SOP No: Insert Number

Draft SOP Title: Qualification, Experience and Training of Clinical Research

Personnel

5.

SPECIFIC PROCEDURE

5.1

Training requirements
Training requirements should be in accordance with the responsibilities of each
individual in his or her respective task (s). All clinical research personnel should be
trained on the following as appropriate:

5.1.1

Good Clinical Practice (GCP) and applicable regulatory requirements

Good clinical practice is an international ethical and scientific quality standard for
designing, conducting, recording, and reporting trials that involve the participation of
human subjects. All study personnel should have GCP training.
There are several ways to obtain GCP training e.g. face-to-face interactive classroom
training (preferred method), online training or self-study.

5.1.2

Department Clinical Research SOPs

SOP training may be done in a face-to-face session conducted by a trainer or selfstudy.

5.1.3

Study specific training

Study specific training should include study protocol, investigational medicinal
product, study procedures, informed consent taking, Case Report Form completion
and other relevant training determined by the CI/PI.

5.2

Documentation
Education, training and experience must be appropriately documented.
Documentation can be in the form of training certificate, Training Form or sign-in
sheet of a meeting/training session together with the meeting/training agenda. For
self-study, the trainee must sign to attest that he/she has read and understood the
training material.
Documentation of medical or other qualification and clinical/research experience of
study personnel should be in the form of CVs. CVs should be signed and updated at
least annually or as significant changes occur.
Documentation should be filed appropriately e.g. Trial Master File, department
training file.

6.

FORMS/TEMPLATES TO BE USED
Where Forms/Templates are referenced in the text, the numbers and titles are listed
under this section.
Training Form
Delegation of Responsibilities and Signature Log

Adapted from CTRG Template SOP version 3.1

Copyright: The University of Oxford 2009

Page 3 of 4

STANDARD OPERATING PROCEDURE

Insert Department
SOP No: Insert Number

Draft SOP Title: Qualification, Experience and Training of Clinical Research

Personnel

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

7.2

External References
ICH Harmonised Tripartite Guideline for Good Clinical Practice.
Research Governance Framework for Health and Social Care, 2nd edition, 2005

8.

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).

SOP no.

Effective
Date

Significant Changes

Adapted from CTRG Template SOP version 3.1

Copyright: The University of Oxford 2009

Page 4 of 4

Previous
SOP no.