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© © All Rights Reserved
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SOP10: Standard Operating Procedure for
Project Management
Authorship tear: John Willams & Anne Seagrove for Joint SOP Group on Tal
Processes (viz Alex Nicholson, Leanne Quinn, Jemma Hughes, lan Russell)
Approved by WWORTH JMG (lan Russell in chair) on 13 March 2009
Signature, Date.
0 Version Record
Version number | Effective dato | Reason for change:
0 “6.14 2008 | Creaton
a 18 Ju 2000 | Further amend
oz Ju 2000 [Furth arenas
3S Fthe ahendirte
aa Futter amendriante
05 Further amenarerte
os ‘Rig 000 Furth armenaronts
ar 17 Sep 2008. | Further amends foning ISOPG group
08 ‘2650p. 2000 | Changes scsepted
os 8 Get 2008 | Changes olowng feedback Wom JS05S
a0 25 Nev 2008 [As above
ox ‘G2 sez000 | JG conan
40 (04 Dec 2000 | Approved in prio a JIG
1 ‘Way 2010 | Nino fomatng amendmen
12 180g 2011 | Prepare SOP for JSOPG. NS
43 1508 2011 | Further amendments foting 1SOPS
4a 18 Jan 2072 | Further amends folowing JSOPS.
20 ‘O2ige 2012 | Autherised for use by JEG
24 106 Jun 2013 | Update nesder and formating amendmanis
22 (Hay 2014 [Remove rsinng ig post JSOPG discussion “NSE CS
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1 Table of Contents
0 Version Record
1. Table of Contents
2 Glossary 3
3 Introduction. 3
4 Purpose: ‘
5 Rolos and Responsibilities. 4
8 Proced tn 5
6.1 Flow chart for project management 5
62. Phncipes of Project Management 6
6.3 Development of research proposal 6
64 Project Intiaton 7
65 Project planning 7
65.1.» Esablenmont oho proc aragamontcbuct 8
652. Igeniheaton. development and management of products e
1853. denieabon of proaict dependencies. 8
{854 Development ofa project managomen pan or Gait char. 5
655 _Develonment of budget monay & tm) management system 18
86 Project execution 40
8.7 Montoring and contro! 10
68 Project closure. 40
7 Training Plan.
8 References.
9 Related SOPs...
10. Appendices vornvsnunnnnnnsninnnnnnnnnnnannnnnninnnnnl
Append 1° Example of a Risk Log 43
Appendix 2. Example of@ Gant cat. 14
‘Append 3: Example of a Project Management Structure 45
“Appendix 4 Exarnple proferma of Product Description. 16
‘Append: § Example f Product Desorption fora Final Report 18
Appendix 6: Example ofan Issue Log 20
‘Append: 7: Example proforma forreporing to TMG 2
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2 Glossary
The full Glossary Is in Swansea University H_ drive/Documents/626-
WWORTH/Development Group/Glossary, The terms of particular relevance to
this SOP are:
Product ‘An input or output, whether tangible or intangible, that can
bbe described in advance, created and tested. A product
‘may be tangible like a printed publication or a website, or it
‘may be less concrete ike a training course or some form of
service or approval. It may be part ofthe final outcome or
an intermediate element which is essential tothe work of
delivering a projec. Plans, communications, case report
forms and quality checks are all examples of products,
hich may also comprise a collection of other products (eg
a quality plan may comprise criteria, approval process and
checklists)
Product ‘A Rierarchical structure that breaks down a final product
Breakdown into its constituent sub-products.
Structure
Product ‘When a product is dependent upon the development
Dependency | completion of another product.
Product ‘A structured format of presenting information about a
Description project product consisting of a description ofa product's
purpose, composition, derivation and quality citer. [tis
‘written as part of the planning process, as soon after the
heed for the product is identified to ensure thatthe people
involved know why iis needed, what it wll |ook lke, from
what sources it wil be derived and the quality specication
of the product
Scope Defines the boundaries of a project (what is andis not
expected of a project). The scope of products can also be
defined.
Stakeholder | Anyone who has an inlerest or Involvement in a project
Task ‘Something that needs to be dane to complete a product of
the project. Can be spit into sub-tasks.
3 Introduction
Standard Operating Procedures (SOPs) are succinct formal documents
Gosigned to achieve consistency in specified tial functions by speciying
standard practice in performing those functions (GCP 1.65 & 5.1.1 ~ EMeA,
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2002). While SOPs should cite relevant legislation & regulations, and key
references & evidence, they need not expound theory.
WWORTH SOPs should accord with all relevant regulations, including the
European Union Clinical Trial Directive, ICH Good Clinical Practice (GCP) and
the current NHS Research Governance Framework, They will seek to
clatingulsh between regulations for CTIMPs and for other research,
This document forms part ofthe set of Standard Operating Procedures (SOPs)
of the West Wales Organisation for Rigorous Teals in Health (WWORTH) an
escribes the roles, responsibilties and actions necessary for the effective
management of randomised trials and other rigorously designed studies.
4 Purpose
‘The purpose ofthis SOP is to describe the principles of project management
and ‘give an example of process "(parly derived ftom the project
management methodology, PRINCE2) for managing a. clinical tial which
Covers project inition, planning, execution, monitoring, contol and closure of
Studies’ undertaken with the suppor of WWORTH, and the actions and
responsibiltes required Yo undertake these steps. For the purpose of this
‘SOP, the term ‘project’ encompasses all trials and studies adopted by
WWORTH,
5 Roles and Responsibilities
‘The Chief Investigator is responsible for the overall delivery of the project,
and for the effective implementation of this SOP, with the support of the
TMITC. All members of the project team are require to follow the processes
and procedures set out in the SOP.
Trial Manager'Trial Coordinator is responsible for day-to-day project
management.
AAll members of the trial team are responsible for effective application of
project management principles.
Trial Administrator is responsible for maintaining appropriate systems for the
effective application of project management princes.
WWORTH Manager is responsible for supporting the Cl to establish project
management principles before the appointment of a TM/TC and to support the
TTMITC in working with those principles,
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6 Procedure
6.1 Flow chart for project management
t
gece eee eon
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62
63
Principles of Project Management
Project Management (PM) Is the discipine of planning, organising and
‘managing resources to bring about the successful completion of spectic
project goals and objectives. The primary challenge of PM is to achieve
All of the project goals and objectives, while honouring. the project
Constraints, which typically are time, budget, quality and scope. A
successful project will be completed on time, on budget and with specified
quality measures.
Etfective project management should
‘© Clarity what has to be achieved
Clarify roles and responsiilties
Focus on shared goals
Pan, monitar and conttol the budget
Plan, monitor and manage of co-ordinate human resources
necessary for project completion
Minimise risk
‘Communicate to all involved
Manage change
Ensure that dependencies are identiied and completed
Ensure that original project objectives are met and planned outputs
delivered OR are renegotiated and amended with the project
‘commissioner and then met, with amended outputs delivered
Within WWORTH, the person responsible for implementing PM wil usualy
be the TM and where possible this person should be involved at the
earliest stages of project planning
Development of research proposal
When a research proposal is conceived, a protocol is developed and bid
for funding drawn up (see WORTH SOP13 Protocol Development)
Project management issues should be identified and the funding applied
for should include adequate resources for PM.
{risk assessment should form part of this process (see WWORTH SOP31
‘Sponsorship and Adoption) which should include:
‘+ Identification ofthe sources of risk (Appendix 1)
‘+ Assessment ofthe likelihood of risk
‘+ Assessment ofthe magnitude of risk
‘© Development of a response
‘+ Documentation ofthe process
At this stage, all stakeholders should be Identified and their roles and
‘expectations clarified and agreed,
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64
65
The research proposal wil also include an estimate of timescales. These
should be estimated realistically taking into account major dependencies
and presented as a high level Gantt chart (see Appendix 2).
Project Initiation
Once resources have been agreed, the project intation stage can start.
This stage ensures that the scope of the project is clarified and the
resources reviewed 0 that the final contract agreed with the funder Is
appropriate to ensure that the project is effectively delivered, The roles
land responsbiltes of the Cl and TM/TC with respect to project
‘management should be explicitly formulated at this stage. A TM may not
be in place at this stage; the WWORTH Manager may work with the Cl
‘and other stat as appropriate in the meantime.
Key aspects of project initiation include:
‘© Contracting and subcontracting
‘+ Recruitment of stat
+ R&D & information governance and ethics processes and
regulatory processes if appropriate (WWORTH SOPI4 Ethics
Approval, WORTH SOP15 MHRA Approval)
+ Support or approval of professional bodies
Project planning
The following sections outline a recommended approach to project
management, Project planning should ideally star before the contractual
start date, It will include:
‘+ Establishment ofthe project management structure (Appendix 3)
‘+ Identification, development and management of products
(Appendices 4 & 5) (including issue and risk logs - Appendices 1 &
8)
‘+ Identification of product dependencies
‘+ Development of a project management plan or Gantt chart
‘+ Development of budget (money & time) management system
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6.5.1 Establishment of the project management structure
The independent Trial Steering Committee (TSC) will oversee the overall
direction ofthe project (see WWORTH SOP17 Monitoring).
The independent Data Monitoring and Ethics Committee (OMEC) wil have
responsbilly for monitoring data quality and patient safety, reporting tothe
TSC (see WWORTH SOP17 Monitoring and WWORTH SOPO9 User
Inclusion),
The management of the tial will be overseen by a Trlal Management
Group (TMG), usually chaired by the Chief Investigator (CI). The TMG.
should include team leads, e.g. lead statistician, qualtaive lead, outcomes
lead, The TMG should meet at regular intervals and receive structured
reports on progress (Appendix 7) from team leads. The TMG will report to
the TSC. See Appendix 3 for an example of @ project management
structure although the exact stricture will vay ftom project to project.
Advisors, external reference groups and stakeholders should all be
included in the planning process.
6.5.2 Identification, development and management of products
The starting point for managing @ project effectively is to have a clear
Understanding of what you ate trying to achieve, This ean be thought
about in terms of products. Products are what are created to achieve a
project and can be final or intermediate. An example of a final product Is
the ‘Final Report; an example of an intermediate product is Ethical
approval obtained” A starting point would be forthe project to define what
the desired products are. This requires ‘staring with an end in mind’ and
should focus the project planning,
At an early stage all the necessary products of the project should be
Identified. This can be achieved by bringing members of the project
together to use brainstorming processes. ‘Postif notes can be used to
tecord the products. The ‘Postit! notes can then be used to create a
product breakdown structure -a structure that breaks down a final product
Into its constituent sub-praducts. This helps to ciany al necessary work
taachieve the final product
The products to be developed should be project plans addressing
communication, documentation (see WWORTH SOPO1b Document
Control), financial procedures, quality (see WWORTH SOP1Ga Quality
Management) and analysis, followed by specific products to meet the
needs of the study from start to finish, including publication plans (see
WWORTH S0P29 Trial Reporting)
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Products should be described in a Product Description (a proforma,
Appendix 4 and an example, Appendix 6 are attached,), including
purpose, scope, composition, derivation, format, presentation and quailty
assessment. The author of a Product Description should be the person
responsible forthe product and it should be agreed by the TMG.
Project documentation will be kept in accordance with WWORTH SOPO1b
Document Control. From the project management perspective it will
Include project plans, product descriptions, roles and responsibilties of
research team, agendas and minutes of meetings, reports, issue and risk
logs.
Separate Risk and Issue Logs should be established (see examples
Appendix 1 and 6) to recard risks to the effective completion of the project
{and issues which need to be addressed (see WWORTH SOP3t
‘Sponsorship and Adoption and WWWORTH SOP32 Misconduct). The Risk
Log should be derives from the inal risk assessment undertaken during
project development (see WWORTH SOP31 Sponsorship and Adoption).
Each isk and issue should be allocated @ unique number, dated,
described, accorded an appropriate status (e.g. Issue ~ High, Medium,
Low. Risk’ closed, reducing, increasing, imminent, no change). The Logs
should be reviewed at each TMG and TSC. Details of risks and Issues
that have been closed must be retained but can be moved to a separate
spreadsheet
6.5.3 Identification of product dependencies
The product breakdown structure can be used to determine the sequence
in which products should be produced and the interdependencies between
them. Flowehans are an effective way of ilustrating these
Interdependencies using arrows flowing In the appropriate drection(s) to
and from products.
Identification of product dependencies wil enable time-scales to be
clarified and ensure essential pieces of work are not omitted. For
‘example, research activity at a Wal site Is dependent on local approvals
local approvals ate dependent on approval from REC (see WORTH
‘SOP{4 Ethics RG Approval) and MHRA (see WWORTH SOP15 MHRA
Approval) the later are dependent on a study protocol being submitted to
REC and MHRA for approval
6.5.4 Development of a project management plan or Gantt chart
(Once products have been described and their dependencies identfied, the
tasks needed to achieve the products can be identified and the duration of
these can be estimated. A detailed Gantt chart can then be developed
(see example Appendix 2). Projects should be divided into phases with
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clear completion dates of each phase, at which progress should be
reviewed by the TSC.
6.5.5 Development of budget (money & time) management system
Inaddition to the TSC, DMEC and TMG, PM controls should be developed
that are consistent with the risk and complexity of the project. These
should include mechanisms to monitor project finances and resources and
a process to manage change (see 6.7).
Expenditure should be monitored against planned expenditure and any
discrepancies discussed withthe sponsor or funder.
6.6 Project execution
Execution of the project will use the products (usually processes of some
sort) defined in the planning stage to deliver the final product(s) identitied
in accordance with the project management plan.
6.7 Monitoring and control
Monitoring and control comprises those processes necessary to
Understand how the project and its products are progressing and ensure
that potential problems can be identified in a timely manner and corrective
action taken (see WWORTH SOP17 Monitoring and WWORTH SOP18a
Quality Management
A clear change management policy should be identified for the
assessment and authorisation of any changes to the project. This should
include: a process for recording change requests; a process for accepting
(oF rejecting change requests; methods for preventing unauthorised
changes: a system for informing appropriate stakeholders of changes.
‘Monitoring of products can be done using their Product Description as 2
basis for what was spectied and comparing it to the product actually
developed to determine whether it has deviated outside tolerable levels
(which are stated in the Product Description). An appropriate member of
the TMG, should assess the quality of any product and it should not be the
product owner (see WWORTH SOP{Ga Quality Management).
68 Project closure
The sponsor will be informed of any changes to the end date of the
projec; documentary evidence will be required.
Project closure should not take place before formal acceptance of the final
product by the project funders. The sponsor will be notified about project
fextansion and closure.
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For the majority of projects execution of the publication plan and
dissemination plan will continue after the project funding has finished.
7 Training Plan
AIIWWORTH staff involved with tals must undertake the appropriate generic
{and tril-specifictrining to ensure that they mest with the specific employers
mandatory Vaining requirements and the specific requirements of the tal. For
‘example, for SU stat, all new employees must attend induction, fre and safety
training (as well as role-spectfic traning courses, e.g. laboratory safety). For
‘new staff, additonal taining requirements should be identified alongside the
specific role requirements and the WWORTH Unit Manager should make
provision for the new staff member to attend the necessary courses as soon
after appointment as is practicably possible.
Its the responsibilty of the WWORTH Unit Manager (alongside the Cl or TM)
to identify all the SOPs that ave relevant to a specific Wal and in whieh the new
member of staff should be trained. The WWORTH UM o: the SOP author wll
provide group training for tral staff and/or one-to-one training, as required for
‘new staff in relation to the speciic SOPs identified. Training records should be
filed both by the main employer and the staff member, in accordance with the
specific employer requirements. Trial specific raining should be fled in TMF
or TSF as appropriate and every individual involved in a tral should have an
individual training record (see WWORTH SOPO2 Training)
Where the tasks spectied in the individual SOPs are delegated to WORTH
staff, ClsiPls or TMs, these delegated staff must ensure that they have
attended a training course on GCP and keep up-to-date through attending
Teftesher courses.
Itis the responsibilty of the C/PI to ensure that all staf allocated duties on the
study delegation log template of responsibilites are suitably trained in the
activities linked to those duties (see WWORTH SOP16 Site Setup, Appendix 9
and Appendix 10).
Each trial should maintain a central training log and ensure that WORTH
hhas access to that log, not least to integrate the logs of staff who work on more
than one tal. Similarly tals should ensure that each site maintains a local
training log, not least to integrate the logs of staff who work for more than one
sponsor
Training in this SOP willbe in two stages. First, taining inthe principles of
this SOP will take place during monthly meetings of the JSOPG. Second,
training in using this SOP in practice wil take the form of regular supervision
by one of the authors. The trainer and trainee will sign the Training Log
(Appendix 8) to confirm that taining is complete.
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‘The TMITC should undertake project management training for clinical trials.
The TDM and clerical staff should receive training in project management
principles at an early stage in the project either from the TM/TC or course
attendance,
‘Swansea University provide PRINCE2 and project management courses,
References
1. PRINCE2 Managing Suocessful Projects with PRINCE2 Manual, 2009,
Office of Government Commerce, The Siationery Office,
2. PRINCE2 website —http:inww.prince2.com
Related SOPs
WWORTH SOP 4b Document Control
WWORTH SOPO7 Trial Closure
WWORTH SOPOB Archiving
WWORTH SOP09 User inclusion
WWORTH S0?13 Protocol Development
WWORTH SOP‘ Ethics Approval
WWORTH SOP15 MHRA Approval
WWORTH SOP17 Monitoring
WWORTH SOP 18a Quality Management
WWORTH S029 Trial Reporting
WWORTH SOP31 Sponsorship and Adoption
\WWORTH SOP32 Detecting and Managing Misconduct, Serious Breaches
‘and, Deviations from GOPIProtocol
Appendices
[Appendix 1 - Example of Risk Log
Appendix 2 - Example of Gantt chart
Appendix 3. - Example ofa project management structure
‘Appendix 4 = Proforma for Product Deseriation
Appendix 5 ~ Example of Product Descripion fora final report
‘Appendix 6 - Example of issue Log
‘Appendix 7. — Proforma for reporting to TMG Capoten ud Cortenn Crea Rear
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Appendix 1: Example of a Risk Log
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Appendix 2: Example of a Gantt chart
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Appendix 3: Example of a Project Management Structure
XOX Project Management Structure
mes }--| nse |
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= L aot
btanooement | =
i
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Appendix 4: Example proforma of Product Description
[ete ot Product Descrption eo)
Author
Document Ref
‘Version number
Date
Revision Hi
‘ate
Dibaton Ste
Date Version creat Disb at
pray is omer aus owe aaa
|*Scanencans]Versen ‘neat —— Rae a oR
samo
Tae Name by which prods kan
purpose Tye rors?
S090 Tre ence cova of prot
CompositionContents | List fhe parts of the product, eg product were a document this would
be ast of he expected chaptrs or sections
Derivation stare the nputfsourees tom when te product is dove, le. where
has the prosucvoutoome coms fom? Ether a document ar another
fiction
Responsiity nos responsible or preparing he complated product?
Format & presentation | Standerd appearance to which ie product must conform
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‘Quality crore
To what stander) dose the product aed to conform and how wil those
inspectingrevaning te ovcame know the standard (ity measures)
have been met? This may be by reference fo ane o more camman
andarae documented esewhore or nerhage uly expaning the
charatense fob sped
‘Quality check method
The process or checking eg fs, review, inspection, 0 be used 0 check
tne qual of inetionaly ofthe product.
Quaiy tolerance
Detaiso ny range nthe quality eres within une the produ would Be
acceptable. This may be accompanied by a sores oF periods during
‘ach the product quaty i requred to improve so tell rai vain
tolrance
‘Quality check skis
required
Ether identification of the people who ere fo check he gual, 2 ndeaton
ofthe shilerequredto doo ora pointer fo uhch aress shoul supply he
Shocking resources.
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Appendix § Example of Product Description for a Final Report
‘Deals of Product Description (PD)
Product name | wae Fil Report
PD Author(s) |
PD Owner oo
PD Filename aoe
PD Filetype | ais word 2008,
a
‘Summary of changes ‘utior Version
Creation of dat report xe Twa toaugzo0e
Distribution date
"9802008 V8 1080
prove cocina requires he bg apa
*Sbeanen go Vesion tame Rae one ore
sory
“Omugz09 | ve het investigatr | 2082008
Te Final Repo
Purpose “To ensure a he prosuebon a the Final Report alle agreement with
unr] to conduct and por onthe esearch project 30.
Sa “The Final Report will clude a ‘formation fom the sud
prc
‘equtedo prowidethe nding body withthe evidence about he two rugs
‘hat are beng compares
Cemposiion/Contorie | Tile page
List of abbroviatinsialossary
Executive summary
(nomere than 1500 words, appear tron of report as unumbored
‘sect, no eferonces, igre of ales)
Introduction
“incising ete background and explanation of alone)
morose
inducing no about pariopants, interventions, objectives, outcomes,
sample size, rancemisaton, birding, statstial metnods, summary of
Sry changes tothe project protocol
‘Section fo inlade quantita, qualtave, scones, FT andoutine
‘sea meine
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Ineeraes orenastontrfoerus alin et ORTH cl ate Untin Sane
eae antane aeg Mason “arse erty Canoe ane
ot cere ber Pe Srowon vi in Sonera Sg Pa
a Pron (12 645 Er.
Racal
Tincusingpartspant fo, erent, baseline data, numbers
snayen,oxtoms ana estmnaon anlar anaes, aovers ats)
‘Seton to lade quantiatve, qualitative, seanories FT and routine
‘tare
Discussion
{incding lnterpretation, geneaissblty, vert evidence)
Conclusions
Tinsuaing impcaione of hsathcare, ecommendatons fr rsoarch
eanoweagrerts
ferences
Append
a de rte a
Sartre saa anaes] ara cays
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Repaid Racers nar Conia oe aoa
Feat an 17 De dacno van alot ater CO ROM WN EHO
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