STANDARD OPERATING PROCEDUREInsert Department

SOP No: Insert Number

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

SOP NumberInsert Number

SOP TitleQualification, Experience and Training of Clinical Research Personnel

NAME TITLESIGNATUREDATE

Author

Reviewer

Authoriser

Effective Date:

READ BY

NAMETITLESIGNATUREDATE

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. ScopeThis 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. responsibilities4.1 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.

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 self-study.

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

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.EffectiveDateSignificant ChangesPreviousSOP no.

Adapted from CTRG Template SOP version 3.1 Copyright: The University of Oxford 2009Page 4 of 4