The purpose of a Project Management Plan (PMP) in business is to define the scope, outline responsibilities and provide guidance on a specific project, task or undertaking with the actual ‘plan’ being a formal document that has been approved for use to direct both project execution and project control.
If we look at each study or protocol as an individual project, then a formalised, documented project management tool for sites to use to approach these protocols seems like a reasonable fit to manage such a process.
For a research business, we can use reliable project management principles to highlight both site and collaborative stakeholder accountability, not only in regards to Good Clinical Practice and Human Research Ethics, but fundamental aspects of quality business management such as customer satisfaction (Sponsor, CRO, participant), consistency in service delivery, improved organisational efficiency and enhanced confidence in your sites capacity to achieve a diverse range of scientific, professional or commercial goals.
A site can develop a standard, succinct template to achieve this quality project management by following the normal structure of a PMP but with application to any clinical trial.
For a site a PMP template is a business tool, designed to be a dynamic document, amenable to change, version controlled and completely transparent, it needs to be shared with all of the stakeholders within the study excepting participants. Studies change, stakeholders vary and an investigation must respond to progressive data analyses so you may need to update the PMP several times over the course of a trial. Provision of this documented plan to the sponsor, investigative team, 3rd party providers and your co-workers can set you apart from other sites and provides direct evidence of your organisation’s commitment to the clinical trial agreement and acknowledgement of obvious risks to your business. If you can empathise with every stakeholder involved in the trial process than you can begin to anticipate problems, apply appropriate risk management and corrective action and ensure your study management service is consistent by cultivating a business application to clinical trials that is focused on quality planning, quality assurance, quality control and quality improvement. Your project management plan is focused not only on protocol adherence, participant care and service quality, but also on the means to achieve it.
Project Management Plan Template Inclusions:
1. PROJECT OBJECTIVES
Outline your research business objectives in undertaking the study. For example, you may want to:
- Understand, identify and manage risk working in new relationships with new Investigators, new clinical indications and new support staff
- Provide optimal and efficient recruitment of trial participants
- Provide appropriate and timely compensation and reimbursement for services
By establishing your business objectives, you have created qualifiable standards to which you must now hold yourself against. (You have to follow through with what you have documented you are going to now)
2. BACKGROUND AND STRATEGIC CONTEXT
Document some background and strategic context for internal business reference this can help provide a foundation for the decisions you have made during the feasibility and start-up phase of a study. This also allows you to formulate a starting point from which the remainder of you plan extends from.
Our company and investigators Dr ______were identified by Sponsor, to consider conducting the tasks associated with managing the above mentioned clinical trial. Dr ________ had been approached by CRO on behalf of Sponsor due to his medical specialty and access to a suitable population for which the intervention under investigation could be applied.
Informal initial discussions regarding start up negotiations and standard practices were undertaken, mainly based on establishing:
- a) Principal Investigator commitment to the proposed project,
- b) Establishment of a Sub-Investigators
- c) That a recruitable population for this treatment did exist, and that the treatment offered benefit to potential participants, and that
- d) COMPANY was suitably qualified and resourced to achieve all the support requirements for the study.
It was deemed the project was worthwhile pursuing. Investigator-specific standard costs ranges were discussed formally, based on COMPANY’S standard Investigator fees and fair market value. These values as well as site start-up, study management and participant support were incorporated into initial budget negotiations that commenced in early January 2016. Final Sponsor approval on the study budget was received in April 2016. All start-up tasks including ethics submissions have were undertaken concurrent to these negotiations.
3. STUDY GOVERNANCE
By outlining each role in the study and then documenting specific key contacts for each including phone numbers, emails and availability, each person in the process now has a clear responsibility and accountability and reporting pathway. As we intend to distribute this to everyone involved, all delegates now know who the Sponsor, CRO, Site and vendor team members are, encouraging open communications and facilitation of complaints management systems and human resource allocations.
- Project client/Owner (Director/PI/etc.)
- Project Sponsor
- Project Manager (Clinical Research Manager/Lead CTC)
- Study Manager (Lead CTC)
- Project Management Team members (Admin/Clinical/Contractors)
- Steering Committee (Key personnel)
4. STAKEHOLDER MANGEMENT PLAN
How are you going to manage each stakeholder? How will you foster meaningful collaboration over the course of a clinical trial? How can you avoid problems associated with interactions between them and you site?
These may include as an example some of the following:
- Weekly email regarding study progress
- Provision of as much notice as possible for impending study tasks and/or meetings
- Consultation on any new developments that may affect study progression, including safety events
- Provide 7 day a week/24hr a day availability for enquires, safety concerns, study questions
- Provide flexible and efficient assessment, appointments and completion of study tasks
- Provide specialist clinical oversight and management as well as supporting physicians in case of emergency
- Provide efficient and concise completion of all start-up and regulatory documentation including insurances and Budget negotiations
- Provide availability during business hours to answer enquires
- Provide a link to Investigation team
- Provide quality data and timely reporting
- Make appropriate time available for meetings, correspondence and study related tasks.
4.4 SITE RESEARCH STAFF
- Provide suitable training, time and resources to achieve intended project outcomes
- Maintain a quality management approach to study and site management including regular internal audits, safety checks and risk assessments.
- Provide weekly study meetings to discuss study progress and generate innovation
- Provide documented recruitment plans to achieve recruitment goals.
4.5 HUMAN RESEARCH ETHICS COMMITTEE
- Provide initial HREC submission with accompanying regulatory documentation to an exceptional standard
- Provide annual reports
- Create site-specific, version-controlled study documentation
- Provide safety reports when required
If you can explore each and develop a management method to address any barriers related to the stakeholders you have identified, you are again creating a documented accountability that provides evidence of consideration for all collaborators involved and highlights the roles each team member will have to undertake to ensure these professional relationships are positively sustained.
What are the assumptions involved in relation to your role in the study, with reference to the protocol? E.g.:
- COMPANY will design, develop, test, and deploy the PMP for the study.
- Five staff will be working at dedicated times for the study.
- Staff working hours occur on an 8:00am-5:00pm schedule. Availability and on-call after hours
- Availability of Investigators at reasonable, agreed times
- Study specific documentation will be completed within reasonable time frames
- Availability of 3rd party vendors at reasonable, agreed times (imaging, pathology)
- COMPANY Research equipment and facilities are in good working order
What are the constraints and how are you going to manage each? E.g.:
What are your necessary priorities to actually execute the study? Plan dates for completion so that they get done. E.g.:
- Perform protocol feasibility assessment
- Facilitation of training and education for study authorities and responsibilities including arrangement of Investigators meeting
- Facilitation of PMP Documentation, appropriate service agreement, clinical trial agreement (CTA) and codes of conduct.
- Complete feasibility processes, ethics submission, budget negotiation, recruitment and PMP.
- Facilitation of study and Investigator reimbursement tracking systems to account for all work performed
6. PROJECT RISK ASSESSMENT
What are your main risks involved? How are you going to prevent them? How will you manage them if they arise? Being prepared is an obvious necessity. If the risks profile is unacceptable, why are you doing the study?
- Study Cancellation/Withdrawal from site
- No participant enrolment
- Slow participant enrolment
- Scheduling difficulties
- Protocol violations
- Protocol deviations