Chapter 5 Project Management

5.1 Project management for Clinical trials

5.1.1 What

Project management is the application of processes, methods, knowledge, skills and experience to achieve the project objectives (Warburton_2014, PMBOk_2013).

5.1.2 Why

Given their complexity, Clinical Trials benefit from well-developed project management plans and monitoring processes. In this module we delineate provide guidance for management of funded clinical trial from planning through execution and closeout.

5.1.3 How

Overview of the project management process

For the purposes of management, it is useful to consider explicitly three phases of the trial execution process: a pre-trial phase, characterized by setup activities; the trial execution phase, comprising those activities (enrollment, measurement etc.) that constitute the major trial activities, and relying heavily on study monitoring and evaluation; and a study closeout phase, consisting of activities such activities as creation of final regulatory reports, publication and archiving (Figure 5.1). Investigators should anticipate a heavy investment of resources during the pre-trial phase, but with proper planning this investment will pay dividends during trial execution and closeout.

Figure 5.1 Simplified temporal overview of the management process for an intervention trial

This module will briefly define the requirements and challenges for project management for a clinical trial, and highlight potentially helpful approaches and tools for each. Documentation; human subjects concerns; development and use of a project management plan; management of personnel and interpersonal communications; and diagnosis and correction of problems will be discussed. For each of these, guidelines and useful templates are provided. Given their critical importance, activities embedded in the pre-trial phase are emphasized (see Figure 5.2).

Figure 5.2. Example flowchart depicting high-level summary of Pretrial activities and their order. In bold are the activities covered in this module. For details click on each activity relevant to each trial phase.

Figure 5.3. Example flowchart depicting high-level summary of trial activities

5.2 Management of trial documentation

See Essential Documentations Module

Table 5.1 Project management activities relevant for trial documentation presented by Phase

Trial Document/Activity Pre-trial Execution Closeout
Regulatory Binder Set up; establish location for storage and security Review/update and document changes on key trial documents Complete and archive regulatory binder
Protocol Review and approval by relevant parties Manage and document protocol amendments; obtain relevant approvals Archive all relevant documentation; submit to relevant authorities as necessary
Credentials and competencies Gather research team documentation (i.e., resumes,onflict of interest forms, evidence of completion of required certifications) Maintain study roster, record of competencies, and responsibilities chart Archive
Investigator Brochure/Marketing Develop marketing materials/ investigators brochure Manage and document updates; obtain relevant approvals
Manual of Procedures Develop MOP; test procedures Update and track changes throughout trial; maintain version control Archive
Statistical Analysis Plan Statistical Analytic Protocol Review SAP; generate signoff by relevant parties Update and track changes throughout trial; maintain version control Archive
Data Safety and Monitoring Documents Author charter; recruit DSMB members, assign chairpersonship in partnership with funders Circulate open and closed session reports at previously agreed upon interval prior to meetings. Submit to relevant authorities (e.g. DSMB, IRB, funding agencies) Archive
DSMB Report Develop template report; obtain relevant approvals Update and track changes throughout trial; maintain Develop and disseminate final version control DSMB report; Archive
Meeting Templates Design meeting templates (agendas and minutes) Co-author and maintain meeting records; disseminate key information
Tracking / Monitoring Reports Develop tracking and monitoring templates for enrollment, study visit attendance, protocol adherence, etc. :Maintain record of findings as motivation for process improvement, changes to procedures and protocol amendments
Data Quality Reports Develop reporting of data completeness and quality Maintain record of findings as motivation for process improvement, changes to procedures and protocol amendments
Additional Documentation Develop study logs, documentation of adverse events, tracking of participant disposition, IRB submissions and approvals, etc. Update and track changes throughout trial; maintain version control Maintain and archive record of all relevant reporting

5.3 Management and maintenance of human subject protections and other regualtory interactions.

See Essential Documentations and Human Subject Protection and Research Regulation Modules.

5.4 Management of trials activities during pretrial and execution

5.4.1 Creating a Project Management Plan

5.4.1.1 What

A Project Management Plan is a document that results in a dynamic set of documents that clearly define the goals and provide direction for the project. It articulates the specific deliverables, as well as procedures, timelines, and resources necessary to produce those deliverables, as well as quality measures to meet the required standards. The plan should be based on the scope of the project as defined in the protocol. The following tasks are critical to creating a project management plan:

  1. Define the project goals/deliverables/milestones
  2. Management using outline-based and/or graphical tools for calendars and schedules
  3. Management of internal and external communications
  4. Management of project personnel and responsibilities

5.4.1.2 Why

A well-designed project plan increases the likelihood of successfully managing a clinical trial. It supports coherent organization, effective management, facilitates transparency, and the detection of foreseeable problems/ issues via monitoring of the project’s critical path. The process and subsequent documentation of all the project progress keeps things focused and moving forward.

5.4.1.3 How

5.4.1.3.1 Define project goals/ deliverables/ milestones

The project goals, deliverables and milestones are described in the trial protocol. The protocol should be taken as the essential and controlling guide implicating the relevant protocol management activities.

5.4.1.3.2 Organizing structure

Project managers should be guided by an overarching structure. For instance, in a large and complex trial with a large number of deliverables, investigators and managers may utilize a formal Work Breakdown Structure (WBS). The WBS is a hierarchical decomposition list of necessary tasks, with each descending level representing an increasing detailed definition of the work. Importantly, the WBS is designed to be focused on generation of deliverables, i.e. tangible work-product such as protocols, procedures and study reports. The WBS provides a mechanism to parse deliverables into smaller manageable components; the duration and cost of each step in the process can thus be better established at a granular level.

For a smaller project, it may not be the case that a formal WBS is necessary or efficient, but the detailed breakdown of specific tasks, along with resources required, is almost never wasted effort. Thus the following sections outline a system that is almost always relevant to project management, but that may be adopted more or less formally as circumstances dictate. The WBS can be developed using calendaring, graphical and outlining tools.

5.4.2 Management using outline-based calendars and schedules

A key component of the project’s success is the management of its schedule. The project manager should:

  • Define all activities required to produce each of the project’s deliverables.
  • Define the order or sequence in which the activities must happen and the relationship between them.
  • Establish the resources (both human and material) necessary to accomplish each activity.
  • Estimate the activity duration.

These items may be applied both at the high level of the project – where, for instance, “develop protocol” might be a single task – as well as at the detailed level, where many tasks necessary to protocol development may be broken out in detail. While the latter is a substantial outlay of resources, it is important to note that the scope of a task and the resources required are more easily estimated for smaller sub-tasks. Accordingly the work invested in breaking out tasks in detail may well be worth it in a complex project.

An example of a simplified schedule specific to protocol development is given in Table 5.2; task start and end dates, human resources, and other materials would typically be added to this.

Table 5.2 Example of a schedule specific to protocol development

Activity Code Activity/ Deliverable Duration (days) Predecessor / Prerequisite
A Draft Protocol 30
B Circulate Protocol Draft for Feedback and Input 14 A
C Integrate changes 18 B
D Circulate Draft Protocol for final Feedback and Input 14 C
E Finalize Protocol 8 D

In the above example, the activities occur in a linear fashion where one must precede the next. Other activities and tasks may more easily and efficiently proceed along multiple, parallel tracks.

5.4.2.1 Management using Graphical Tools

Other management tools that may be helpful in creating the project timeline or process maps include flowcharts, Gantt Charts, and network diagrams. We present some examples of the use of these tools below.

Flowcharts - are graphical depictions of the process flow corresponding to the outline format exemplified by Table 5.3. A flowchart replicating Table 5.3 would consist of a series of boxes laid out in boringly linear fashion and would therefore be of limited utility. For more complex development along parallel tracks, by contrast, a graphical depiction offers considerable advantages, as shown in Figures 5.2 and 5.3. These flowcharts depict pretrial, execution and closeout activities at a high level. Once again, each of the components of the activities depicted here could itself be the subject of a detailed tabular or graphical breakdown. A key strength of these organizing tools is their applicability at the level of granular detail and high-level project overview, simultaneously.

The Network Diagram is an enhanced flowchart that associates each task with a duration and, potential, anticipated resource expenditures. This is particularly useful in helping the investigative team understand the impact of delays in any task on the overall timeline. Because many tasks have prerequisites while others may be worked on in parallel, it is not the case that delays in different tasks will have similar impact.
A useful concept, therefore, is the critical path of the project. This is defined as the longest sequence of tasks stretching from project start to finish. It has the feature that account for the fact that in delays in any of the activities along the path will lead delay completion of the project, unless this delay can be made up elsewhere along the critical path. These concepts are illustrated in Figure 5.4.

Figure 5.4. The project critical path is outline in orange; any delays along this path imply an elongation of the total project duration.

Management of internal and external communications

Key elements of the communications plan include:

5.4.2.2 Opportunities for communication

The management team should assist in developing a schedule of interactions between members of the investigative team, as well as with internal and external stakeholders. This should include transmission of formal reports, and also the times, locations, duration, and attendees of meetings and other interactions.

5.4.2.3 Means of communications

The management team should assist in procuring, testing and maintaining the means of project communications. These should be chosen such that capabilities correspond to project needs. Ease of use and reliability are additional key features that must be emphasized.

5.4.2.4 Recording of communications and trial progress

The project management team should take an active role in maintenance of the record of communications, including meeting minutes and agendas. Under some scenarios, stakeholders (e.g. funding agencies) may reserve the right to determine the official level of high-level interactions, in which case the management team may contribute as appropriate.

5.4.3 Management of project personnel and responsibilities

The management team should develop a roster of personnel based on the roles and responsibilities of team members. Ideally this will identify the individuals primarily responsible (i.e. those that execute the work) and accountable (i.e. those ultimately answerable for the completion) for each function and task. Teams may additionally elect to identify -those who have secondary responsibilities relating to consulting on, or approval of, specific tasks and functions.

5.5 Supporting plans

5.5.1 Problem assessment and mitigation management plan

Every clinical trial is subject to problems that may impact the normal progress of the project. Fundamental to the trial’s success is the development of a comprehensive issues assessment and mitigation plan. During the planning phase it involves the identification and quantification of potential challenges that can impact (positively or negatively) the trial and/or its progress. Based on the assessment, the manager should develop a response plan. During trial phase the manager is to monitor and control the possible issues. The purpose of a problem assessment during the development stage of the trial is to first improve the study design and to be able to successfully manage both the foreseeable and unforeseeable problems.

5.5.1.1 Problem Management Response Plan

After identifying and evaluating potential problems that may impact the trial, it is advisable to develop a problem management response plan. The purpose is to develop response strategies to reduce the potential of a problem to occur, or minimize its impact if it does. The main components of the plan should include:

  • Issue management scope and objectives
  • The methods to identify, assess, quantify, response, monitor and control the issue/ problem.
  • Personnel involved in the analysis and response processes.
  • The tools assigned to enhance opportunities and reduce threats to the trial’s objectives.
  • Issue/problem prioritization (i.e., the level of impact to the schedule, budget and/or quality of the trial results).
  • A response plan for tracking identified problems, monitoring the residual issues, identifying new problems, and evaluating issues process effectiveness throughout the trial.
  • Communications plan for the distribution of problem update reports.

The key for a successful problem management plan is to maintain a constant monitoring and reevaluation of the potential problems as well as the circumstances in which they emerge. As problems evolve differently during different phases of the trials it is important to be vigilant and be adaptable.

5.5.2 Clinical site management plan

Another essential element of the clinical trial’s execution and its success is the Site Management Plan. Site Management goes beyond simply monitoring a site. It focuses on regular, consistent communication with site stakeholders during the pre-trial, trial, and closeout phases. The first step in the process is to identify a reliable, primary point-of-contact for the site during the course of a trial. Is equally vital that sites understand the importance of maintaining regular communications with the primary study site or study Sponsor, depending on trial type. Sites should also have a solid understanding of whom to contact with questions, issues, and concerns that may arise at any point during the trial.

The Site Management Plan should include a set of expectations, organization, and the establishment of metrics to track performance, and building and strengthen relationships. Table 5.3 provides a list of activities to undertake during the different phases of the trial.

Table 5.3 Site Management Plan during the different phases of the Clinical Trial

Pre-trial Execution Closeout
Define sample size (Krishnankutty_2012) and recruitment strategies Review/ monitor data collection issues Complete final source data verification of Case Report Forms (CRFs/ eCRFs), ensuring protocol adherence, and managing the collection of final safety data
Review site feasibility and qualifications for the study
Define recruitment timeline
Establish Site contact/ develop relationships with sites Keep an updated list of staff turnover for the sites
Create site training and provision of study documents for the in-service presentation (i.e., Introductory letters/ handouts/ brochures/ HIPAA waivers) Re-in-service sites as often as needed (to keep momentum of the trial)
Recruit sites Monitor site (remotely or on-site) according to regulations Ensure all documentation (regulatory correspondence) is filed appropriately and ready for the clinical monitor or Clinical Research Associate (CRA) to review during the close-out visit
Follow-up site with phone calls to administrators and track those communications in a log
Hire/ Train/ Develop field staff
Set meeting schedule for the staff Meet with staff weekly at first to problem solve. Then change to bi-weekly or monthly
Develop site monitoring/Quality Assurance log Update log
Define roles of study field staff vs. sites responsibilities
Inform sites on performance and contractual issues Track problems/ issues and their resolutions
Ensure return or destruction of all study related materials (i.e., unused lab kits and CRFs)

The appropriate level of site management and oversight empowers sites to effectively recruit, treat, and retain subjects, while ensures regulatory compliance, protocol adherence, the protection of subjects’ right, subject safety, and overall management of screened and enrolled subjects. Presenting a clear understanding of the communication flow will often reduce protocol violations and deviation, an address data issues and questions, thereby increasing the quality and integrity of the clinical trial data.

5.5.3 Budget management plan

All financial aspects of the trial must be documented in an agreement between the sponsor and the investigator/institution. A budget management plan should aim to monitor the budget continuously as the trial progresses given that delays and/ or changes on the trial’s scope may negatively impact it. Scope creep or the tendency to add requirements to the scope, often results in deliverables being out of schedule and the trial being over budget. For this reason the budget management plan should also include a routine schedule for revisions and updates.

5.5.4 Clinical Data Management Plan

The design of the research data lifecycle should be strategized in the clinical data management plan (CDMP). The exact content of the CDMP will vary on the type of trial, the number of sites involved, and the sponsor’s specifications. Among the recommended items to include are:

  • Clinical data management definition and procedures
    • Systems for data collection and management
    • Data entry procedures
    • Data security procedures
    • Data cleaning and quality control procedures
    • Data import and exports procedures
    • Case Report Forms (CRF)
  • Monitoring of study participants
    • Screening/Recruitment
    • Randomization/Blinding procedures
    • Cessation of Intervention
    • Withdrawals
    • Tracking
  • Reporting
    • Safety
    • Adverse events and Serious Adverse Events
    • Screening and Enrollment
    • Data Quality and Completeness
    • Progress and Final Reports
    • Additional Reports
  • Trial Documents and Data Retention
    • Retention of Trial Documents
    • Data Use Agreements (DUA)

For details see the Data Management Module. Also IFAR’s Sensitive Data Security Policy and Boston Children’s Hospital Guideline for Developing a Manual of Operations.

5.6 Special considerations for older subjects

None

5.7 Common Pitfalls

  • Lack of management follow-up and poor communications systems.
  • Failure to submit amendments or keep up with study documentation updates.
  • Not keeping up with staff certifications.
  • Personnel turnover and a lack of redundancies buildup.
  • Lack of compliance with regulations.
  • Missing reports deadlines due to a lack of organization in the calendar.
  • Research sites closures during the trial collection cycle.
  • Unanticipated scope changes that affect the budget and schedule.
  • Ineffective recruitment.
  • Ineffective mechanism to maintain blinding.
  • Ineffective use of technologies.
  • Failure to update security systems.

5.8 Resources

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@website{HHS_hippa, tittle = {Health Information privacy: The De-identification Standard}, organization = {U.S. Department of Health & Human Services}, usl = {http://www.hhs.gov/hipaa/for-professionals/privacy/special-topics/de-identification/index.html}, }

@website{Catalyst, title = {Harvard Catalyst Regulatory Atlas} organizatin = {The Harvard Clinical and Translational Science Center}, url = {http://connects.catalyst.harvard.edu/regulatoryatlas/?mode=c&id=51} }

@website{BCH_RPG, title = {Research Practive Guidelines} organizatin = {Boston Children’s Hospital}, url = {http://www.childrenshospital.org/research-and-innovation/research/clinical/clinical-research-center/research-practice-guidelines} }

@website{BCH_RPG-05, title = {Guideline for Developing a Manual of Operations (MOO)-RPG-05} organizatin = {Boston Children’s Hospital}, url = {http://www.childrenshospital.org/~/media/research-and-innovation/clinical-research-center/rpg_03_final-12115/rpg052014.ashx?la=en} }

@website{BCH_RPG-07, title = {Guidelines for Research Data Collection-RPG-07} organizatin = {Boston Children’s Hospital}, url = {http://www.childrenshospital.org/~/media/research-and-innovation/clinical-research-center/rpg0711-14-14final.ashx?la=en} }

@website{NIA_NIH_toobox, title = {Clinical Research Study Investigator’s Toolbox} organizatin = {National Institute on Aging}, url = {https://www.nia.nih.gov/research/dgcg/clinical-research-study-investigators-toolbox/startup} }

@website{OpenClinica, title = {Fundamentals Aspects of Electronic Data Capture} organizatin = {Open Clinica}, url = {https://www.openclinica.com/electronic_data_capture/} }