Training of University of Birmingham Staff
UoB QMS reference number: UoB-GEN-TRN-SOP-001
Purpose:
This Standard Operating Procedure (SOP) describes how training should be performed on
procedures captured in the University of Birmingham (UoB) Quality Management System (QMS).
Scope
The SOP is applicable to all UoB staff members, holding either substantive or honorary contracts,
using the UoB QMS. In addition, topic specific QMS such as the Clinical Trials QMS may refer to this
SOP.
Implementation plan:
This SOP is implemented directly after its effective date. Use of this SOP, or any other QMS referring
to it, should be evident on training records.
Date of implementation:
28-Aug-2014
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Document code:
UoB-GEN-TRN-SOP-001
Version no:
1.0 (EAv1.0)
Print Date:
28-Jul-17
Page:
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Training of University of Birmingham Staff
Abbreviations and Definitions:
Term
Description
CV
Curriculum Vitae
Employee Training
Record
Record of any training sessions that relate to previous and current functions
and that are relevant for the current post
Manager
A person within the UoB who takes on line management responsibilities.
This is typically an academic related or support staff function.
PDR
Performance and Development Review
Policies
Policies are developed to describe the approach of the UoB on areas that
heavily regulated. Policies may also be developed when there is ambiguity
in how regulatory requirements should be implemented in the QMS or when
procedures to be captured in the QMS address areas controversial within
the UoB at the time of implementation. Policies explain why the UoB has its
procedures, especially when they seem to deviate from the regulatory
requirements. Policies should be read in conjunction with the relevant SOP.
Policies that are not part of a Quality Manual are coded up as ‘POL’.
Principal
Investigator
The investigator is responsible for the conduct of a clinical trial at a trial site. If a
trial is conducted by a team of individuals at a trial site, the investigator is the
leader responsible for the team and may be called the Principal Investigator.
QCD
See ‘Quality Control Document’
QMS
See ‘Quality Management System’
QMS Development
Team
Team of UoB staff members responsible for developing and maintaining
either the UoB QMS or a QMS referring to the UoB QMS, e.g. Clinical
Trials QMS.
Quality Control
Documents
Quality Control Documents can be for example instructions, forms,
templates or checklists. They are developed to share best practices,
promote standardisation to guarantee quality standards are maintained and
reduce resources otherwise needed to develop similar documents. Unless
indicated otherwise in the relevant SOP, QCDs are not mandatory and are
designed to be an optional aid to UoB staff.
Quality Management A Quality Management System (QMS) is a system that includes procedures
and policies to describe how certain tasks should be performed and that
System
encapsulate any standards and/or regulatory requirements that may apply
to those tasks. By adhering to the Quality Management System, the user
and the UoB will be assured that applicable regulations are adhered to.
SOP
See ‘Standard Operating Procedures’
Standard Operating
Procedures
Standard Operating Procedures are detailed written instructions to achieve
uniformity in the performance of a specific function. They define tasks,
allocate responsibilities, detail processes, indicate documents and
templates to be used and cross-reference to other work instructions and
guidance or policy documents. They are standards to which the UoB may
be audited or inspected.
Document code:
UoB-GEN-TRN-SOP-001
Version no:
1.0 (EAv1.0)
Print Date:
28-Jul-17
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Training of University of Birmingham Staff
UoB Lead
The UoB Lead is a (senior) person in the UoB who takes responsibility for
the conduct and delivery of those parts of the study which are either carried
out at or managed/overseen by the UoB. Normally this would be an
academic researcher, but in some cases it may be a senior member of a
UKCRC registered UoB CTU..
See also the Glossary of Terms.
Background:
Key to a successful Quality Management System is training of staff on the policies and processes.
The University of Birmingham Code of Practice for Research 2014-15 explains that the Principal
Investigator is accountable for undertaking professional development relevant to the research and
ensuring that all others involved in the research have received relevant training. Training typically
starts during an employee’s induction period, and is expected to continue thereafter.
This SOP covers the general process. It is expected that for each topic the required training will be
described in the topic specific instructions, SOPs and/or quality manual.
Responsibilities:
Principal Investigator/ UoB Lead / Manager (or delegate)
 Recruit staff members who are appropriately qualified by education and experience to perform
tasks, or who would be able to perform their tasks following further training.
 Ensure staff members within their team are appropriately trained (and that this is
documented); this includes:
o Up to date training on applicable regulations and standards (see also further details in
relevant Quality Manual e.g. for Clinical Trials the Clinical Trials Quality Manual)
o Training on the relevant documents from the UoB QMS
o Training on the relevant activities
o Consider mentorship – see references
 Assess and confirm competency to perform a specific task/activity/procedure, where
applicable
UoB staff members working with the UoB QMS or any QMS referring to the UoB QMS:
 Maintain an up to date version of:
o Curriculum Vitae containing proof of relevant education and experience and a signed Job
Description as this specifies the tasks assigned to the staff member
o Proof of training (and competency where applicable) on relevant legislation, standards,
policies, SOPs and Quality Control Documents (QCDs), e.g. via certificates of attendance,
signed training attendance sheets, training logs and/or the Performance and Development
Review (PDR) report detailing training attended
 In collaboration with the Principal Investigator / UoB Lead / Manager (or delegate), identify
personal training needs and set up training, including:
o Up to date training on applicable regulations and standards
o Training on relevant UoB QMS documents
o Training on the relevant trials/projects
 Attend mandatory training sessions or arrange for an appropriate alternative if attendance is
not feasible
 When changing jobs, ensure a copy of the up to date CV or signed job description and proof
of relevant training is left with the Principal Investigator / UoB Lead / Manager as this provides
proof the staff member was appropriately qualified for the tasks they took on during part of the
trial/project
Document code:
UoB-GEN-TRN-SOP-001
Version no:
1.0 (EAv1.0)
Print Date:
28-Jul-17
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Training of University of Birmingham Staff
QMS development teams:
 Decide on appropriate training plan for documents within the UoB QMS and document the
training plan
 Where possible, advise Principal Investigator / UoB Lead / Manager on available training, for
example for clinical trials GCP training
Document code:
UoB-GEN-TRN-SOP-001
Version no:
1.0 (EAv1.0)
Print Date:
28-Jul-17
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Procedure:
Document code:
UoB-GEN-TRN-SOP-001
Version no:
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Print Date:
28-Jul-17
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* Training methods may include:
 Notification; consider sending policy/SOP/tool via E-mail for information only
 Read and understand: consider sending policy/SOP/tool via E-mail requesting staff member
to confirm on a Training Log that they have read and understood and/or would like further
explanation
 Demonstration; consider plenary session vs. small scale training sessions and use of Training
Attendance Log
 Practice; consider setting up workshops and use of Training Attendance Log
 Apply; consider setting up mentorship
 Staggered training; notification followed by more detailed training at the time the
policy/SOP/tool becomes relevant for the individual
Related documents:
 UoB-GEN-TRN-QCD-001: CV template; see for an example the NRES Guidance on
submission of CV; http://www.nres.npsa.nhs.uk/applications/guidance/guidance-and-goodpractice/?entryid62=66824 at time of writing
 UoB-GEN-TRN-QCD-002: Employee Training Record template
 UoB-GEN-TRN-QCD-003: Training Attendance Log template
References:
 University of Birmingham Code of Practice for Research 2014-15:
o http://www.birmingham.ac.uk/Documents/university/legal/research.pdf
 University of Birmingham mentorship scheme:
o https://intranet.birmingham.ac.uk/hr/development/academic/mentoring.aspx
 Information regarding PDR:
o https://intranet.birmingham.ac.uk/hr/employment/pdr/support.aspx
o https://intranet.birmingham.ac.uk/hr/employment/pdr/support-faq.aspx
o https://intranet.birmingham.ac.uk/hr/employment/pdr/academic-teaching.aspx
Acknowledgements:
The first version of this SOP has been based on the equivalent CRCTU SOP, and aspects of the
equivalent BCTU and PC-CRTU SOPs have been brought into the SOP. We would like to thank all
staff members within the CTUs who have been involved in developing these CTU SOPs for their time
and efforts.
Document code:
UoB-GEN-TRN-SOP-001
Version no:
1.0 (EAv1.0)
Print Date:
28-Jul-17
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Development summary:
Author:
Name:
Jane Steele
Signature: See original copy
Function:
Director, Advanced Therapies Facility
Date:
See original copy
Reviewed by:
Clinical Trials Oversight Committee
Anna Hutton, CRCTU QA Manager
Nicola Fenwick, CRCTU Team Manager
Authorised by:
Name:
Wilma van Riel
Function:
Clinical Trials Quality Assurance Manager
Date:
See original copy
Issue date:
14-Aug-2014
Supersedes:
N/A
Signature: See original copy
Reason for update:
N/A
Review of final version:
Date:
Reviewed by:
Signature:
Outcome:
N/A
Document code:
UoB-GEN-TRN-SOP-001
Version no:
1.0 (EAv1.0)
Print Date:
28-Jul-17
Page:
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Editorial Amendments
Tick box if not applicable
Reason for update:
Administrative update: style and links updated
Date of amendment:
27-Jan-15
Supersedes:
UoB-GEN-TRN-SOP-001 v1.0 28-Aug-14 – Training of University of Birmingham staff
Editor:
Name:
Conor McGoldrick
Function:
Clinical Trials Compliance Officer
Date:
27-Jan-15
Signature:
See original copy
Signature:
See original copy
Authoriser:
Name:
Wilma van Riel
Function:
Clinical Trials Quality Assurance Manager
Date:
Document code:
UoB-GEN-TRN-SOP-001
Version no:
1.0 (EAv1.0)
Print Date:
28-Jul-17
Page:
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