GOOD CLINICAL PRACTICE (GCP) TRAINING
REQUIREMENTS FOR PATIENT RELATED
RESEARCH STUDIES
STANDARD OPERATING PROCEDURE NO
SOP 11
DATE RATIFIED
Sep 2014
NEXT REVIEW DATE
Sep 2016
POLICY STATEMENT/KEY OBJECTIVES:
This Standard Operating Procedure aims to provide guidance to researchers
regarding GCP training requirements at Lancashire Care NHS Foundation Trust
POLICY AUTHOR: Beverley Lowe; Research Senior Officer
Page 1 of 4
10-09-2014
Final V2.0
Corporate Directorate
Chairman: Mr Steve Jones
Chief Executive: Professor Heather Tierney-Moore OBE
BACKGROUND
Good Clinical Practice (GCP) is an international ethical and scientific quality
standard for designing, conducting, recording and reporting trials that involve the
participation of human subjects. Compliance with this standard provides public
assurance that the rights, safety and well-being of trial subjects are protected;
consistent with the principles that have their origin in the Declaration of Helsinki, and
that the clinical trial data are credible.
http://en.wikipedia.org/wiki/Good_clinical_practice
http://www.crn.nihr.ac.uk/learning-development/good-clinical-practice/
PURPOSE
This Standard Operating Procedure (SOP) aims to clearly describe the procedure for
completing GCP training and the procedures for sending the certificate to the
Research department once completed.
PROCEDURE
WHO?
It is the responsibility of all researchers who are carrying out a research project
involving NHS patients and carers to complete GCP training and to update this every
2 years. Student research is exempt from this requirement; however it is strongly
recommended that all individuals undertaking research involving patients complete
this training.
HOW?
GCP training information can be accessed via the NIHR Clinical Research Network:
North West Coast or from the Research Department. The Research internet training
page details individuals’ requirements for GCP training in the Trust:
http://www.lancashirecare.nhs.uk/about-us/Research-Innovation/research/RIEvents.php
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10-09-2014
Final V2.0
Corporate Directorate
Chairman: Mr Steve Jones
Chief Executive: Professor Heather Tierney-Moore OBE
Training courses are provided free of charge for all staff working on patient related
studies.
Individuals aligned with a portfolio study may access the National Institute for Health
Research (NIHR) GCP training program; to access the course, researchers should
register with the NIHR Workforce Development http://www.crn.nihr.ac.uk/learningdevelopment/good-clinical-practice/ and log into the Learning Management System
(LMS), select ‘my learning plan’ and book onto the courses available. For guidance
to complete these tasks please contact the Research department. Upon completion,
the certificate will appear as an electronic document in ‘my learning plan’.
Individuals who are not aligned with a portfolio study can access GCP training free of
change at https://live.blueskybroadcast.com/bsb/client/CL_DEFAULT.asp?Client=6
or alternatively access the training through their Higher Education Institution (HEI).
The certificate must be emailed across to the Research department to comply with
the Trusts governance checks process; this is requested via email and/or verbal
communication prior to the Trust permission letter being granted. However, if the
researcher is already known to the Trust and is/has been working on other studies in
the Trust, the GCP electronic folder and records list will be reviewed at this time to
check whether the certificate is in date.
To confirm that the certificate has been received the project checklist is updated with
the details and kept in the project electronic folder.
The certificate is filed in the GCP electronic folder and the details recorded on the
GCP records list. It is the responsibility of the researcher to renew their GCP training
every 2 years.
Researchers are reminded about their GCP requirements in the Trust permission
letter and on the Research web-site.
Page 3 of 4
10-09-2014
Final V2.0
Corporate Directorate
Chairman: Mr Steve Jones
Chief Executive: Professor Heather Tierney-Moore OBE
The Research department will monitor any training which is about to expire by
checking the GCP records list on a monthly basis and by highlighting the expiry date
in red. If any training is due to expire in the forthcoming month, the Research
department review the end date of the research project to check whether training
needs renewing. If an individual’s training is due to expire and the project is still
active, they will receive an email notification requesting a new certificate and
reminding them about their responsibility to keep their training up to date.
When the new certificate is emailed to the Research department, the study checklist
is updated, the certificate is placed in the GCP electronic folder and the GCP records
list is updated accordingly.
GLOSSARY
National Institute for Health Research (NIHR)
Good Clinical Practice (GCP)
Page 4 of 4
10-09-2014
Final V2.0
Corporate Directorate
Chairman: Mr Steve Jones
Chief Executive: Professor Heather Tierney-Moore OBE