1. The term "project" as used in research
This chapter aims to discuss the term "project" and outline some guidelines for facilitating project progression, thereby increasing the likelihood of completing the project. However, the scientific success of the project will also depend on many other factors.

A research project differs from the standard diagnostic and therapeutic tasks of clinical practice in that it is limited in terms of time and resources, as well as being particularly goal-oriented. The unique features of the research work become more apparent if it is defined as a project. The considerable amount of literature on efficient management of a project may prove useful, also in a scientific project. If the most common "project management tools" are employed, a number of pitfalls can hopefully be avoided.

2. Project definition
A project has been defined as "a unique task which leads to a definite result, is limited in time and requires a variety of resources" (Andersen ES, Grude VK and Haug T. Målrettet prosjektstyring. NKI-forlaget 2004). As such, it entails other performance requirements than those usually associated with hospital work.

3. Project Director ("Prosjektansvarlig"), Project Manager ("Prosjektleder") and responsibility sharing
A number of standard terms are used in the field of project work, although their use varies substantially according to context. The Norwegian terms will also be used in the English version of The Research Handbook, since the correct use of the Norwegian terms is essential. There is certainly considerable confusion with respect to the meaning of the terms "Project Manager" ("Prosjektleder") and "Project Director" ("Prosjektansvarlig"). Although this may appear to be a trifling matter, these distinctions must be clarified before the project commences so that all participants agree on their rights and responsibilities.

The sharing of responsibilities in research projects is to some extent determined by the demands of the Norwegian authorities and the institutions involved (see Chapter 10 for details). One example is the definition of the person/entity responsible for data processing ("databehandlingsansvarlig") and the person/entity responsible for biobanks ("ansvarshavende for biobank") in research projects. In general, the formal responsibilities of supervisors with respect to research projects are often poorly defined, even in cases where binding agreements exist between supervisors ("veiledere"), PhD candidates ("stipendiater") and research institutions (see Chapter 9).

Project Director (Prosjektansvarlig)

In a business, the Project Director is often the entity commissioning the work, this being either a company representative or a client. Transferring this to the scientific world at Norwegian hospitals, the person/entity responsible for a project could be:
· A Senior Manager (Overordnet driftsansvarlig) (Director (Direktør)/ Research Director (Forskningsdirektør)/Consultant (Avdelingsoverlege)/ Head of Department (Avdelingsleder), Head of a Research Unit (Leder av forskningsenhet), Head of Research in a Division or a Division Director (Forskningsansvarlig ved divisjonen eller Divisjonsdirektør). This may be the case where research projects require a license (see section on the Data Inspectorate (Datatilsynet) Chapter 10) or where contracts, financial or otherwise, are appropriate However, some funding bodies such as the Research Council of Norway ("Norges forskningsråd") and the Norwegian Foundation for Health and Rehabilitation ("Helse og Rehabilitering"), require that the Project Director ("Prosjektansvarlig") is the senior manager at the institution/department/hospital where the research takes place, whether or not the study is researcher initiated. At many institutions the managing director, research director or a senior manager at a similar level will sign all project applications and hence be the Project Director (Prosjektansvarlig) on behalf of the institution.
· The commissioning entity ("oppdragsgiver") may be the Project Director (Prosjektansvarlig) in the case of commissioned research (oppdragsforskning), although this may vary according to type of contract with the hospital and must therefore be clarified with one's immediate superior, as well as with the Head of Research. In a multi-centre study there may be a Project Director (Prosjektansvarlig) at each institution.
· The Supervisor ("veileder") may be the person responsible for the project in the case of self-initiated research. In many instances, the person responsible for managing the project ("driftsansvarlig") will be someone other than the Supervisor.

Project Manager ("Prosjektleder")

In the business world, a Project Manager is responsible for running the project on a day-to-day basis. A Project Manager reports to a steering group. In the world of research, the term "Project Manager" is, if anything, even more confusing than the term "Project Director" ("Prosjektansvarlig").

· In smaller studies with a PhD candidate and a supervisor, the PhD candidate may be the Project Manager.
· In the case of commissioned research a researcher ("forsker") or principal investigator ("utprøver") will in some cases be the Project Manager within their own institution or at another institution. Both terms - Project Manager and Project Director (Prosjektansvarlig) - are used in contracts for these types of studies.
· In larger studies with several research fellows a superior ("overordnet") or a supervisor ("veileder") will often be the Project Manager for the entire research project, while the research fellow will be responsible for managing a sub-project in relation to his/her employer ("delprosjektleder").
· Being a Project Manager is not synonymous with ownership of data. Intellectual rights with respect to data should be specified in the project description.

Several funding bodies require the Project Manager to have at least a PhD or equivalent research background

Conclusion:
The researchers' rights and responsibilities in a research project with respect to data, biological samples, practical work and funding must be clarified in advance. A clear and common understanding of the terms Project Manager and Project Director (Prosjektansvarlig) must be sought from the outset of project planning.

4. Goal directed project management ("prosjektstyring")
Goal directed project management may by some be associated with management tasks without particular relevance to research projects. However, it may be helpful to make use of the experience and academic insights of project management to ensure an efficiently run research project. Project management involves running a project in accordance with agreed standards of quality, within the agreed period of time and using the resources available.

Projects are divided into phases in order to clarify what should be done when, using which resources. The phases in a project are typically start-up, planning, implementation, winding down and termination. Although it may seem time-consuming to plan each of these phases, it cannot be overemphasized that thorough planning will save time and frustration. As Eisenhower famously said: "A plan is nothing, planning is everything".

According to project management theory, the Project Manager is responsible for:
· planning, working out a progress schedule
· what is to be done, how and when
· who is to do what (does everyone agree?)
· acquiring sufficient resources for the project (others will often help, but this should be clarified in advance.)
· designing a follow-up and information system for the project
· organizing and following up the implementation of the project
· ensuring that the tasks are carried out according to plan and in the correct manner
· ensuring adequate follow-up and information to all parties involved (progress reports, superiors, steering groups etc.)
· evaluating the project at its conclusion (publications or reports, as required)

5. Aims or objectives
· One of the first, and most important tasks, is to define specific aims and objectives. Without clear objectives, it is unlikely that the protocol, the grant application, the methods or the publication will be very good. The aims of the project must be outlined when applying for a license or notifying The Data Inspectorate ("Datatilsynet") /the Data Protection Officer ("personvernombud", see Chapter 10). The aims provide a framework for, and restrict the use of data.
· Objectives (or overall aims) can be relatively wide-ranging. 
· Aims must be verifiable. In research terms, this means stating hypotheses which can lead to yes/no answers. In scientific terms, however, it is the null hypothesis which is to be disproved or confirmed.

6. Implementation, activity plan or milestone
· An activity plan is a plan showing what is to be done when. This is of particular relevance in grant applications, since the likelihood of the project success is evaluated according to how realistic the implementation of the plan appears to be.
· Milestones are "checkpoints" en route with allotted dates (for example, when a questionnaire on lifestyle factors is validated and approved for printing). A milestone plan provides a useful means of checking if the research project is on schedule. If this is not the case, the consequences must be assessed.

The topic of project work may be further studied on several websites, including:
BI: www.bi.no
Norwegian Centre of Project Management (Norsk senter for prosjektledelse): www.nsp.ntnu.no

Local suggestions and advice at UUS
Each division at UUS has its own research committee ("Forskningsutvalg") whose chairman (employed by UUS in addition to employment at UiO as professors) attend the hospital's main research committee. The function of Secretariat is fulfilled by the Secretary of the Research Committee. Contact the research committee ("Forskningsutvalg") or the person responsible for research in the relevant division/department for advice and assistance in planning research projects. The central staff of some clinics also includes a research adviser. At UUS the Managing Director is responsible for all research ("Forskningsansvarlig"). All applications to external sponsors (for example, to The Norwegian Research Council (NFR, "Norges forskningsråd") or The South-Eastern Region Health Authority ("Helse Sør-Øst RHF") must therefore be signed by the Research and Education Director who acts on behalf of the Managing Director.

In grant applications to "Helse Sør-Øst RHF", the Project Manager must usually have a PhD (or equivalent research experience). See Chapter 10 regarding which local bodies to contact in connection with research projects at UUS.

Local suggestions and advice at Helse Bergen
The Managing Director (on behalf of Helse Bergen) has delegated expert responsibility for individual projects to the relevant operative units. New research projects are to be submitted for approval to the Head of Department/Clinic (Level 2 Manager) at the planning stage. Where appropriate, the relevant department of Bergen University is to be informed about the project.

All applications to external sponsors (e.g. "NFR", "Helse og Rehabilitering", "Helse Vest" etc.) are to be approved by the administration, by a Head of Clinic/Department (Level 2 Manager). The same applies to applications for formal approval of projects by external organizations ("NSD", "Datatilsynet", "REK", "SLV", "HOD", "Helsedirektoratet" etc.).