How engaged are the stakeholders in your clinical data management projects? As you know that the engagement level of stakeholders play an important role for the success of the clinical trial. The attached article explains the importance and processes of managing stakeholders’ engagement in clinical data management. We hope that you find this useful. Connect with us to hear more from our experts in this area.

1. QED Clinical Services
The Learning House, Winter hill, Snowdon drive, Milton Keynes – MK6 1BP, United Kingdom
www.qed-clinical.com
A project is a temporary endeavour undertaken to create a unique, product or service. The
management of data within a clinical trial is a project as it has a definite beginning date, a
definite end date i.e. Database lock and it creates a unique product i.e. standard and
analysable datasets. Thus, it must apply standard project management practices, including
skills, knowledge, tools and techniques to data management to achieve the project objectives.
One of the important knowledge areas in a Clinical Data Management (CDM) project is project
stakeholder management. It includes the processes required to identify the stakeholders to
analyze their expectations and impact on the project, efforts to achieve their maximum
engagement during the data management and then managing and monitoring their
engagement throughout the project.
Who are stakeholders?
The Project Management Body of Knowledge (PMBOK) from the Project Management
Institute (PMI) defines project stakeholders as the people, groups, or organizations that could
impact or be impacted by the project. In context of the CDM, the list of project stakeholders
includes, but is not limited to project data management team, biostatisticians, programming
team, clinical operations team, site personnel i.e. investigators and site staff, clinical
laboratories, external data vendors, safety team, Electronic Data Capture(EDC) vendor, the
sponsor and the regulatory bodies etc.
As per the PMBOK, the sponsor is a
person or group who provides resources
and support for the project, program, or
portfolio and is accountable for enabling
success. Therefore, the sponsor in a
typical project management setup can be
an executive or member of management
within the organization who pays for the
project and identifies and defines the
project. The project in such setup is
usually not involved in the delivery,
instead the project management team is responsible for the project delivery and meeting the
project objectives.
However, as per the ICH GCP, the sponsor is an individual, company, institution, or
organization which takes responsibility for the initiation, management, and/or financing of a
clinical trial. Therefore, the sponsor in a typical clinical trial is a pharmaceutical company
whose molecule is being tested. The sponsor in this setup works closely with the stakeholders.
Though the sponsor can outsource activities to vendors, such as Contract Research
Organizations (CROs), the ultimate responsibility for the quality and integrity of the trial data
always resides with the sponsor.
Identifying the Stakeholders:
The stakeholders should be identified early in the clinical trial. That helps in obtaining important
information about the stakeholders and their interests and expectations in the project.
Identified stakeholders should be documented in stakeholder register. Identifying the
stakeholders should be an ongoing process, starting in the initial stage of the trial through the
completion. For example, when there are new investigators added to the clinical trials, they
Did you know?
Project stakeholders include all those who
can positively or negatively impact your
project. The list can be quite extensive
and should include all stakeholders, some
of which you probably didn’t think about.
Stakeholder identification is thus an
important process.

2. QED Clinical Services
The Learning House, Winter hill, Snowdon drive, Milton Keynes – MK6 1BP, United Kingdom
www.qed-clinical.com
should be added to the stakeholder register and should be considered for appropriate
stakeholder management processes.
Prioritization and Classification of stakeholders:
Stakeholders should be prioritized as necessary throughout CDM lifecycle. For instance,
stakeholders such as EDC vendor and programmers require higher level of attention in the
setup phase of the trial. However, as the trial progresses towards database closure, their
priority level may be reduced. Similarly, Quality teams and Safety teams may have low priority
in the setup phase, however their priority level will be increased as the trial progresses and
will be highest in the closeout phase.
The project manager in CDM should be able classify the stakeholders as internal or external.
Such as an internal biostatistician would be familiar with organizational CDM procedures and
organizational process assets such as database closure checklist. However, dealing with the
external stakeholders such as sponsors or external clinical operations team may require more
detailed planning and considerations to achieve their engagement and meet the expectations.
The prioritization and classification of the stakeholders help in determining the expected level
of engagement and the efforts required for managing and monitoring the engagement of the
stakeholders.
Stakeholder’s engagement:
The success of any CDM project depends largely on the engagement of the stakeholders. The
clinical data manager should have a plan to establish effective interactions with all
stakeholders. The type and structure of the organization play vital roles in planning and
achieving continuous stakeholder engagements.
The Standard Operating Procedures (SOPs) define several elements of stakeholder
engagement, such as, acquiring sponsor or clinical operations team’s approval on database
specification, getting the designed Case Report Form reviewed by the biostatisticians,
interactive portals allowing sites to responding to generated queries etc. The objective for all
such processes is to develop the approaches to effectively and efficiently involve all
stakeholders in the project as per their requirements, expectations and their subsequent
impact on the project right from the kick-off meeting to the database lock.
Appropriate conflict resolution methods
must be applied. It is important to set the
ground rules as per organizational and
project specific requirements and then the
CDM project manager and the project
team and other stakeholders must adhere
to them. The CDM project manager must
demonstrate interpersonal skills for the
effectively managing and monitoring
stakeholder engagement. This is
important while working with internal as well
as external stakeholders, such as the central
lab. The CDM project manager must setup an agreement with the central lab in the initial stage
of the project, set the expectations and understand their process and requirements which
should then be analysed against the project requirements and organizational SOPs. The
cultural differences should be understood to effectively communicate with internal and external
stakeholders.
The success of any CDM project
depends largely on the engagement of
the stakeholders. The clinical data
manager should have a plan to establish
effective interactions with all
stakeholders. The type and structure of
the organization play vital roles in
planning and achieving continuous
stakeholder engagements.

3. QED Clinical Services
The Learning House, Winter hill, Snowdon drive, Milton Keynes – MK6 1BP, United Kingdom
www.qed-clinical.com
References:
1. PMBOK® Guide and Standards
https://www.pmi.org/pmbok-guide-standards
2. ICH Guidelines for Good Clinical Practice
https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/
E6_R1_Guideline.pdf
Contact Author:
Gajendrasinh Chanchu, PMP®, CSSBBTM
Head, Clinical Data Operations
Tel: +91 79 6611 8029
E-mail: gchanchu@qed-clinical.com
Final Thoughts:
The stakeholders’ resistance and lack of support can be upsetting for the project. It is important
that the CDM project manager maintains and monitors effective communication with the
stakeholders, revisits the requirements and communication plan, identifies issues, changes and
risks throughout the CDM lifecycle.