Vendor Management
UoB QMS reference number: UoB-CLN-VEN-SOP-001
Purpose:
This SOP describes the processes for approving vendors for clinical trials.
Scope:
This SOP defines the processes necessary to select and evaluate current and potential vendors for
clinical trials. Where clinical trials are (co-)sponsored and/or (partially) managed by another institution,
this procedure must be followed as far as possible. This SOP may also be used for any other types of
clinical research projects.
Implementation plan:
 For new clinical trials and for clinical trials in the set-up phase this SOP should be followed in full.
 For clinical trials open to recruitment and in follow-up it is expected that the appropriate
documentation of oversight of vendors is in place and evidenced through documentation. In
addition, this process should be followed in full when sourcing and selecting a new vendor, and
ensuring oversight of the new vendor.
 For clinical trials open to recruitment and where the UoB Procurement processes were
required to be followed for vendor selection it is expected that the appropriate documentation
is in place to show adherence to the procurement processes.
 In all other cases documentation regarding the selection processes should be filed in the TMF
where feasible.
Date of implementation:
01-Jan-2016
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Document code:
UoB-CLN-VEN-SOP-001
Version no:
1.0
Print Date:
13-Jul-17
Page:
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Vendor Management
Background:
Clinical trials may require services from a different institution or commercial entity external to the
University of Birmingham. These are known as a ‘vendor’, or a ‘supplier’ or ‘third party service
provider’. This SOP will refer to ‘vendors’. It is essential that a robust appraisal of vendors is
performed, as the responsibility for oversight of their conduct remains with the Sponsor.
Responsibilities:
Sponsor
 Perform vendor assessment as part of vendor selection
 Set up contracts with vendors explaining the standards the vendors will work to, any activities
undertaken by sponsor and vendor, and communications between the two parties
 Oversight of the vendor’s service delivery.
Further duties are delegated to the Chief Investigator, who may delegate further to a Clinical Trials
Unit (CTU) as appropriate.
It is expected that the UoB Contracts Team, in collaboration with the Research Governance Team
and the Chief Investigator, take on the duties for establishing vendor contracts via their local
processes as specified in UoB-CLN-CTM-SOP-001 Clinical Trial Management.
Chief Investigator
For UoB-sponsored trials the Chief Investigator is delegated the duty for identifying and documenting
what trial functions may need to be delegated to a vendor, arranging for the appropriate contract
agreement to be put into place, and the ongoing monitoring of any vendors involved in a trial
The Chief Investigator (or delegate) should determine and document the method to be used to assess
a vendor’s suitability, conduct the assessment, and report on the assessment.
Procedure:
A number of methods can be used to identify a vendor, and subsequently evaluate/assess the
suitability of a vendor to provide the required product/service.
Identification of products/services to be outsourced
The first step is to identify what functions would be preferred/required to be outsourced to a vendor.
This includes identifying any international standards or regulations that must be complied with by the
vendor when undertaking the functions.
It is essential that the need for a vendor and initial costings for their services is identified early in the
trial design and prior to funding application, as this will ensure that any costs can be incorporated in
the funding application.
The University of Birmingham’s Procurement and Purchasing Procedures must be followed to adhere
to the UoB Financial Rules and Regulations, which includes the fundamental principle:
‘Expenditure of University funds must be administered with the highest level of probity and
transparency’; see References for further information.
Use of UoB-internal team(s) as a collaborative resource
In certain circumstances a UoB internal resource is utilised in the trial e.g. a CTU is providing
statistical support. In this case this should be documented in the protocol, and an appropriate method
of agreement e.g. Memorandum of Understanding or other appropriate agreement should be in place.
Identification of a suitable vendor
For items or services in excess of £501 plus VAT (or £10,000 if using a UoB Approved Supplier) the
UoB Procurement processes must be followed; for more information see:
https://intranet.birmingham.ac.uk/finance/procurement/I-need-help/eps2.aspx#eight
To identify a shortlist of prospective vendors which meet the operational requirements to deliver the
required functions any of the following methods could be applied:
 Previous experience with the vendor (due to positive past experience or upon
recommendation from a trusted source), confirming they worked to appropriate standards
Document code:
UoB-CLN-VEN-SOP-001
Version no:
1.0
Print Date:
13-Jul-17
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Vendor Management
 Approved UoB supplier(s)
 Recommendations from others e.g. Clinical Trial Units
 Recommendations by funding body and/or Sponsor.
Evaluation and selection of vendors
Any of the following methods can be used to assess the suitability of shortlisted vendors to provide
the product/ service according to specification and on time:
 Review of marketing material to explain standards being used by the vendor
 Assessment of CVs and previous experience of key staff members
 Obtaining references to show vendor is suitably set up to deliver the product/service
 Vendor’s confirmed ability to meet the needs of the study and to deliver within the specified
time frame
 Previous experience/knowledge of the vendor
 Successful CE marking completed (for medical devices)
 Confirmation that GCP, GMP and/or GLP standards are adhered to(if applicable)
 Correct licences are in place e.g. MIA(IMP) if applicable
 Review of the vendor’s policies, procedures and Quality Management Systems
 Conducting audits and site visits of the vendor
 Company history and stability
 After sales service including training
 Costs
 Preferred providers list of University/lead NHS Trust; Sponsor and/or Funder.
The method used for assessing the suitability of a vendor will vary depending on the risk associated
with the tasks being delegated and previous experience/ knowledge of the vendor, and the chosen
methods should be documented in the TMF.
Contracts
Once a vendor has been selected an appropriate contract between the Sponsor and the vendor must
be negotiated and put in place prior to the start of any delegated tasks. For UoB-sponsored trials it is
expected that this is a collaboration between, and drawing on the experience of, the UoB Contracts
Team, Research Governance Team and the Chief Investigator.
The contracts should clearly define the following information:
 The delegated tasks, duties, functions and responsibilities agreed between the parties,
including contact points, exception management, timelines and an end date
 The required standards of service (i.e. which applicable laws, guidance and procedures to be
adhered to) and how these will be measured (e.g. by receipt of update reports)
 The flow of relevant safety information and how this will be provided (e.g. from IMP suppliers
to the Sponsor)
 Procedure for informing the Sponsor of any protocol non compliances/ Serious Breaches
 Procedure for informing the Sponsor of any routine statutory inspections
A copy of this contract must be filed in the Trial Master File.
Vendor Oversight
There should be documented oversight of the vendor’s activities to ensure compliance with the terms
of the contract, the study protocol, GCP and the applicable regulations. This can take the form of any
of the suggested methods below:
 Monitoring the service provider
 Regular communications with the vendor (e.g. teleconferences or regular meetings). A formal
communication plan can be developed to define the level and frequency of communication
between parties
 Periodic review of the standard of work completed to date (e.g. via audit) including frequency
of review
 Review of specific activities
Document code:
UoB-CLN-VEN-SOP-001
Version no:
1.0
Print Date:
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 Regular documented update reports from the vendor
 Being one of the authorised signatories on key trial documents (e.g. data management/
statistical analysis plans)
 Developing an escalation plan for reporting significant non-compliance issues. This should
also be reflected in the contract between the Sponsor and vendor.
It is expected that the oversight of the vendor is planned prior to the commencement of the service
being provided and that evidence of the selection process and subsequent review required is filed in
the TMF.
Related documents:
 UoB-CLN-CTM-SOP-001 Clinical Trial Management
References:
 MHRA Good Clinical Practice Guide, (UK: The Stationary Office, 2012) Chapter 1 Sponsor
Oversight, 1.3
 The Medicines for Human Use (Clinical Trials) Regulations 2004, Part 4,
http://www.legislation.gov.uk/uksi/2004/1031/pdfs/uksi_20041031_en.pdf
 The Medicines for Human Use (Clinical Trials) Regulations 2004, Sponsor Schedule 1,
http://www.legislation.gov.uk/uksi/2004/1031/schedule/1/part/2/made
 University of Birmingham: Procurement and Purchasing Procedures (revised November 2015)
https://intranet.birmingham.ac.uk/finance/documents/public/Procurement-Procedures.pdf
Abbreviations and Definitions:
Term
Description
CI
Chief Investigator
Chief Investigator
The person who takes overall responsibility for the design, conduct and
reporting of a study if it is at one site; or if the study involves researchers at
more than one site, the person who takes primary responsibility for the
design, conduct and reporting of the study, whether or not that person is an
investigator at any particular site.
Note that for CTIMPs the Chief Investigator must be an authorised health
professional.
MHRA
Medicines and Healthcare products Regulatory Agency; the Competent
Authority in the UK
REC
Research Ethics Committee
Vendor
All the various type of UoB-external providers a Sponsor may delegate their
functions to (e.g. Contract Research Organisation, Laboratory, Consultant,
Freelancer/ Contractor) excluding Research Collaborators and Clinical Trial
Sites.
See also Glossary of Terms.
Document code:
UoB-CLN-VEN-SOP-001
Version no:
1.0
Print Date:
13-Jul-17
Page:
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Vendor Management
Development summary:
Author:
Name:
Conor McGoldrick
Signature:
Function:
Clinical Trials Compliance Officer
Date:
See original copy
Reviewed by:
Wilma van Riel, Clinical Trials Quality Assurance Manager
Razia Meer-Baloch, Quality Assurance Manager, PC-CRTU
Cara Lax-Williams, Quality Assurance Manager, CRCTU
Margaret Grant, Operations Manager, BCTU
Sarah Bowden, Director of Operations, CRCTU
See original copy
Authorised by:
Name:
Prof. Julian Bion
Function:
Chair, Clinical Trials Oversight Committee
Date:
See original copy
Name:
Wilma van Riel
Function:
Clinical Trials Quality Assurance Manager
Date:
See original copy
Issue date:
08-Dec-2015
Signature:
See original copy
Signature:
See original copy
Supersedes:
N/A
Reason for update:
N/A
Review of final version:
Date:
Reviewed by:
Signature:
Outcome:
N/A
Document code:
UoB-CLN-VEN-SOP-001
Version no:
1.0
Print Date:
13-Jul-17
Page:
5 of 5