Dictionary domainTrack E
Research lifecycle stages and project metadata
RAiD-anchored project lifecycle, phases, milestones.
For implementers
Operational deployment checklist for Research lifecycle stages and project metadata: prerequisites, five deploy steps, integration notes for Pure, Symplectic Elements, Worktribe, DSpace, and more, plus the pitfalls that recur in the field.
Terms in this domain
60 terms
Research Support Services
Research support services are the institutional functions -- sponsored-programs (pre- and post-award) administration, core research facilities and shared instrumentation, research data management and IT infrastructure, regulatory and compliance support (IRB, IACUC, biosafety), research development and grant-writing assistance, and technology transfer -- that a university, hospital, or research institute provides centrally or departmentally so individual researchers do not have to build each capability themselves. The term is used both internally (an institution's own research-support-services office or division) and externally, in procurement, where an institution contracts a third-party vendor to provide one of these functions.
Retrospective Study
A retrospective study is an observational research design in which investigators identify subjects, exposures, and outcomes that have already occurred and reconstruct the exposure-outcome relationship from data recorded before the study began -- most often clinical records, administrative/claims data, registries, or prior test results -- rather than measuring events as they unfold going forward. What makes a study retrospective is not its statistical method but the timing relationship between the start of the study and the events under analysis: if the outcome had already happened before subjects were identified and data collection began, the study is retrospective, regardless of whether it is framed as a cohort, case-control, or case-series design. Because the data were typically generated for clinical care, billing, or another purpose unrelated to the study's hypothesis, retrospective studies trade weaker control over data quality and measurement consistency for speed, lower cost, and the ability to study rare outcomes or long latency periods that a forward-looking design could not practically capture.
Pilot Study
A small-scale study that runs a scaled-down but methodologically faithful version of a planned future study’s actual protocol — same recruitment approach, same intervention delivery, same outcome measures and data-collection procedures — in order to test whether the full-scale study is workable, refine its methods and instruments, and generate preliminary parameter estimates (recruitment rate, adherence, rough effect size or outcome variance) before committing to the definitive study. A pilot study is one specific subtype of feasibility study — the one that tests feasibility by actually running the intended methods, rather than assessing feasibility through other means (surveys, record review, capacity audits). It is not designed to formally test whether an intervention works, and it is a distinct concept from a Phase I clinical trial, which is a defined stage in the drug-development regulatory pathway rather than a general research-methodology device.
Delimitations
Delimitations are the boundaries a researcher deliberately sets on the scope of a study during its design -- the population, timeframe, geography, variables, and theoretical framework chosen to include or exclude so the study stays focused and answerable. A factor qualifies as a delimitation, not a limitation, when it was a choice the researcher made rather than a constraint imposed on them: narrowing a survey to one country, one age range, one industry, or one time period are all delimitations because the researcher could have drawn the boundary differently but chose not to for reasons of focus, relevance, or feasibility. Delimitations are stated in the methods or scope section, in the first person and past tense of intentional design ('this study was delimited to...'), and they define what the study's conclusions can legitimately be generalized to.
Cross-Sectional Study
A cross-sectional study is an observational research design in which exposure and outcome (or any set of variables) are measured on a defined sample at a single point in time, rather than by following participants forward or reconstructing their history backward. Participants are selected on inclusion/exclusion criteria for the population of interest, not on their exposure or outcome status -- that selection rule is what separates a cross-sectional design from a cohort study (selected on exposure, followed forward) or a case-control study (selected on outcome, examined retrospectively). Because everything is captured in a single snapshot, a cross-sectional design can describe prevalence and association but cannot, on its own, establish temporal sequence or causation.
Sponsor-Investigator
A sponsor-investigator is a specific FDA regulatory designation (21 CFR 312.3 for drugs/biologics; 21 CFR 812.3 for devices) for an individual -- never an institution, company, or group -- who both initiates a clinical investigation and actually conducts it, personally directing the administration, dispensing, or use of the investigational product to subjects. Because one person occupies both roles, that individual must independently satisfy the full set of sponsor obligations (21 CFR 312.50-312.59) and the full set of investigator obligations (21 CFR 312.60-312.70) under the same IND or IDE -- there is no reduced or merged standard for holding both roles at once.
Research Data
Research data is the recorded, factual material generated or collected in the course of a research project that is needed to validate, reproduce, or build on that project's findings — raw measurements, observations, instrument readings, survey responses, code outputs, and other structured or unstructured records, regardless of medium or discipline. In U.S. federally funded research specifically, the term carries a narrower, load-bearing regulatory meaning under 2 CFR § 200.315(e)(3) (the Uniform Guidance, which consolidated and replaced the older OMB Circular A-110 in 2014): research data means 'the recorded factual material commonly accepted in the scientific community as necessary to validate research findings.' That specific definition is what determines what a federal award recipient must make available in response to a Freedom of Information Act (FOIA) request, and it is the baseline many institutions use to scope what a data management plan (DMP) is actually obligated to describe. Distinguishing 'research data' in this operational sense from the much larger set of everything a researcher produces during a project — drafts, correspondence, physical samples, unfinished analysis — is the first practical step in scoping a DMP, a repository deposit, or a records-retention schedule, and underpins research data management (RDM) practice generally.
Knowledge-to-Action (KTA) Framework
The Knowledge-to-Action (KTA) Framework is a specific conceptual model for how research evidence moves into practice, developed by Ian Graham and colleagues (2006). A project, program, or funder policy is 'using the KTA Framework' when it explicitly structures knowledge translation work around the model's two linked components: (1) a Knowledge Creation funnel of three phases -- knowledge inquiry, knowledge synthesis, and the creation of knowledge tools/products, each stage distilling and tailoring the evidence further -- and (2) a seven-phase Action Cycle -- identify the problem (or identify/select/review knowledge), adapt knowledge to the local context, assess barriers to knowledge use, select/tailor/implement interventions, monitor knowledge use, evaluate outcomes, and sustain knowledge use. The phases are not strictly sequential: they are dynamic and can proceed simultaneously or iterate, and a given initiative rarely needs all seven Action Cycle phases to count as KTA-based, though 'identify the problem' and 'sustain knowledge use' anchor the cycle's start and end. It is a narrower, named instance of the broader knowledge translation concept, not a synonym for it.
Investigator-Initiated Study (IIS)
An investigator-initiated study (IIS), also called an investigator-initiated trial (IIT), is a clinical trial that an individual investigator -- not a pharmaceutical or device company -- designs, initiates, and holds primary regulatory responsibility for conducting. The distinguishing test is not whether an academic clinician is involved (nearly every clinical trial has one), but who originates the protocol and holds the regulatory authorization to conduct it: the Investigational New Drug (IND) application for a US drug/biologic trial, or the Investigational Device Exemption (IDE) for a device trial. Under 21 CFR 312.3, an individual who both initiates and conducts an investigation, and under whose immediate direction the investigational drug is administered, is a "sponsor-investigator" -- a single person who simultaneously carries the regulatory obligations FDA assigns to a sponsor (21 CFR 312 Subpart D, sections 312.50-312.59) and those assigned to an investigator (sections 312.60-312.69). 21 CFR 812.3 defines the equivalent role for device studies conducted under an IDE. This is what distinguishes an IIS from a physician serving only as a participating-site principal investigator in an industry-sponsored multi-site trial, where a company holds the IND/IDE and remains sponsor of record.
Clinical Trials Unit (CTU)
A unit is a Clinical Trials Unit (CTU) when it is a centralized institutional infrastructure -- organizationally part of the same academic medical center, hospital, or university as the investigators it serves, not a separately contracted external entity -- that provides shared, reusable operational services (regulatory support, data management, monitoring, biostatistics, and/or budgeting) to more than one investigator or study across the institution, so no individual Principal Investigator has to build that infrastructure from scratch for a single trial. Investigators engage a CTU internally, through a service agreement, cost-recovery charge, or institutional mandate for certain trial types -- not through a Clinical Trial Agreement the way an external sponsor engages a Contract Research Organization (CRO).
R33 (NIH Exploratory/Developmental Grant)
An NIH R-series research grant activity code that funds the second, expanded-development phase of a milestone-driven, two-phase award — typically paired with an R21 or R61 exploratory first phase (as "R21/R33" or "R61/R33") — where transition into R33 funding depends on NIH confirming predefined go/no-go milestones were met, rather than a new competing application.
Technology Readiness Level (TRL)
A rating on a standardized 1-9 scale describing how mature a specific technology is, from basic scientific principles observed and reported (TRL 1) through an actual system proven through successful operations in its real deployment environment (TRL 9). Originally developed at NASA in the 1970s and formalized as a nine-level scale in the early 1990s, TRL (used interchangeably with the phrasing "technical readiness level") is assigned to a technology based on demonstrated physical/functional maturity alone -- what has actually been built and tested, and under what conditions -- independent of funding source, patent status, or commercial promise. The U.S. Department of Defense, the Department of Energy, the European Commission (Horizon Europe), and university technology transfer offices (TTOs) all use the same nine-level scale, with only minor wording differences at the upper levels.
Updated project plan
The revised project-planning document -- updated work packages, timeline, budget allocation, or personnel roles -- issued after a sponsor has approved a change request. It is the downstream artefact of an approved change, not the change request itself and not the underlying pivot that prompted it.
Project plan
The project plan is the operational blueprint approved as part of a funded award — the document that sets out what work will happen, in what sequence, against what timeline, using what resources, and by whom. It is the reference an institution and a sponsor both compare actual progress against during interim and final reporting across the project lifecycle . Funder-specific forms The project plan doesn't have one universal template; it takes the form a given funder's application process produces. For Horizon Europe projects, Annex 1 of the Grant Agreement (the "description of action
Project metadata
The structured descriptive and administrative fields -- title, PI, funder, award identifier, project period, budget -- that identify a funded research project within a CRIS, grants system, or funder database.
Project ID (RAiD-anchored)
A persistent, machine-actionable identifier for a research project, typically issued under the Research Activity Identifier (RAiD) standard ISO 23527, used to unambiguously identify the project across systems, funders, institutions, and outputs.
Output legacy planning
Planning, undertaken before or during a project's final phase, for what happens to its outputs, deliverables, and communities of practice once dedicated funding ends -- preservation and licensing of data, software, or other outputs, and succession arrangements for networks or infrastructure the project created. Distinct from project closure documentation, which records what was done, not what should happen next.
Post-project sustainability
Post-project sustainability is the broader planning question a funder increasingly expects an applicant to answer: what continues, and how, once dedicated project funding stops? It sits at proposal and reporting stage as a distinct planning requirement in its own right — Horizon Europe's sustainability plans, NIH's data-management and sharing expectations, and UKRI's exploitation plans are the most commonly cited funder-specific forms it takes. The questions it typically has to answer Who will maintain project-built software once the grant ends and dedicated developer time disappears; ho
Lessons learned
A structured retrospective summary of what worked well, what did not, and what the project team would do differently, capturable at any major lifecycle milestone, not only at closeout, to inform future projects.
Project closure documentation
The set of documents produced at project closeout to record final outcomes, lessons learned, deliverables submitted, data archived, equipment disposition, and outstanding obligations, providing an auditable trail for future reference -- the output of the closeout phase, not the process itself.
Offboarding (project)
The structured process of transitioning a team member, or an entire project, out of active involvement, including knowledge transfer, data and code hand-off, access revocation, exit interview, and documentation of outstanding items -- distinct from the award-level closeout phase.
Onboarding (project)
The structured process of bringing a new member -- or, for a consortium partner, an entire new organisation -- into active, compliant participation in an already-running project: provisioning access, delivering mandatory training, and formally accepting the newcomer into the project's governance documents.
Hand-off (between phases)
The structured transfer of project responsibility, knowledge, and artefacts from one lifecycle phase to the next, or between project teams or roles, to ensure continuity and minimise loss of context.
Project hold
A temporary pause of project activity initiated by the project team, the institution, or a regulatory body, for example pending an ethics re-approval, equipment repair, IRB decision, or while a key team member is on leave.
Continuation decision
The sponsor's programmatic and administrative determination, made after reviewing a periodic or annual report, of whether an already-approved multi-year project may proceed into its next budget period as planned. The decision itself -- satisfactory, satisfactory with comments, or unsatisfactory -- is distinct from the continuation award, which is the funding-release mechanism that follows a satisfactory decision.
Termination (grant)
The formal ending of a grant award before its scheduled end date, initiated by the sponsor or recipient, due to non-performance, mutual agreement, loss of funding, or other defined cause.
No-cost extension (lifecycle context)
In the project-lifecycle sense, a no-cost extension (NCE) is the change-request event that shifts a project's end date -- and with it, the start date of every downstream phase -- without adding funds or changing scope. See the tighter ledger/agreement definition at no-cost extension for the funding-instrument view; this entry covers what an NCE does to phase timing and governance.
Change request (project)
A formal request a recipient submits to the sponsor to amend an already-approved aspect of a funded project -- scope, key personnel, budget category, subaward activity, or timeline -- required whenever the change falls on the sponsor's prior-approval list, most concretely enumerated at 2 CFR 200.308(f) for US federal awards.
Project pivot
A substantive change in a funded project's scientific approach, methodology, or direction, made in response to early results, external circumstances, or a changed environment -- normal and often necessary, but compliant only once it has been assessed against the sponsor's prior-approval rules and, where it changes the project's scope or objective, formalized as a change request.
End-of-project review
A formal evaluative meeting or process held at or near a project's end to assess whether it met its stated objectives against the original plan, typically involving the funder's programme or project officer and, for larger awards, external experts -- distinct from a mid-project interim review, and from the later, broader impact evaluation that may follow independently.
Mid-term review
A formal review conducted at approximately the midpoint of a research project, evaluating progress against aims, resource utilisation, and the realism and feasibility of the plan for the remaining project duration.
Interim project review
A formal, funder-initiated progress check conducted at a defined mid-point of a multi-year project -- assessing whether work is on track against the plan and informing continuation, adjustment, or corrective-action decisions -- distinct from the routine interim report it draws on and from the end-of-project review held at project close.
Annual report (grant)
The reporting deliverable a recipient submits once per year of a multi-year award, combining a narrative account of progress with, where the sponsor requires it, a financial update -- the most common cadence for the interim report in US federal and UK funding, but not itself a synonym for either 'financial report' or 'final report.'
Archive phase
The final lifecycle stage, beginning once closeout reporting is complete, in which a project's outputs -- data, code, documents, and equipment records -- are placed into long-term stewardship: deposited in repositories, registered with persistent identifiers, and retained for whatever period funder policy and 2 CFR 200.334 require. It formalises what happens to a project's outputs after the award itself has formally ended.
Reporting phase
The recurring lifecycle activity during which scheduled progress and financial reports are planned, drafted, internally reviewed, and submitted to the sponsor -- distinct from the reporting period it covers and the interim report it produces.
Execution phase
The main project lifecycle phase during which the planned research activities are carried out, deliverables produced, milestones achieved, and the bulk of grant expenditure occurs.
Award phase
The stage of the research-project lifecycle between formal award issuance and project close-out, covering budget execution, progress reporting, personnel management, and amendments.
Proposal phase
The lifecycle phase covering preparation, drafting, internal review, institutional approval, and submission of a research proposal to a funder, ending with proposal submission.
Idea phase
The earliest phase of the research project lifecycle, in which a researcher identifies a question, surveys the literature, drafts a research concept, and explores potential funders and collaborators before committing to proposal preparation.
Project lifecycle
The full sequence of stages a research project moves through from first concept to final archival, used as the organising framework for governance, planning, and hand-offs across a project's life: idea, proposal, pre-award, post-award (execution), closeout, and archive. "Project lifecycle" names the whole sequence; "project phase" names any one stage within it.
Subtask
An internal subdivision of a project task, used for detailed planning, effort tracking, and execution management, typically not formally reported to the sponsor but tracked within the consortium or research group -- distinct from a formally reported task.
Task (Horizon Europe)
A subdivision of a Horizon Europe work package, representing a specific activity with defined objectives, contributing partners, person-month allocation, and link to particular deliverables or milestones, defined in the Application Form and Grant Agreement Annex 1.
Work package (Horizon Europe)
A defined sub-component of a Horizon Europe project that groups related tasks, deliverables, and milestones under a single work-package leader, with its own budget allocation and timeline.
Project deliverable
A tangible, verifiable output produced by a project, such as a report, dataset, software release, prototype, or publication, formally documented in the project plan with a due date and responsible work package or partner.
Project milestone
A significant intermediate point in a project, marking achievement of a key activity, completion of a deliverable, or successful transition between phases, used to monitor progress against the project plan.
Project phase
A defined segment of a research project's lifecycle, characterised by a specific objective, set of activities, deliverables, and decision gates, used to structure planning, execution, and reporting.
Sharing
The extent to which a work, such as a publication, dataset, or other research output, can be discovered, accessed, and reused by people other than its author(s).
Document version
During the development of a document there are usually several iterations of the work. There are periods along the authoring process that can be identified as a specific identifiable point where the work can be identified as a specific version of the work.
Deposit
The action of uploading a digital copy of a work into a digital repository or similar service by the author(s) or their agent, together with metadata that, ideally, supports FAIR principles (Findable; Accessible; Interoperable; Re-usable).
Date of start of embargo
The date that an embargo comes into force and from whence the length of the embargo period is counted. The start date of a period during which access to a document or file or record is restricted. This could be: “date of online publication” or “publication date” or “date of online availability” or “date of deposit”. This date and the triggering event to start the embargo are defined by the copyright holder or the repository governance or the law.
Date of publication
The date the work is made available to the public by a publisher, including by means of an electronic retrieval system; the earliest date the final version of record is made available on the publisher's website.
Date of online publication
The date that a work was first published on an online publishing platform. This may be before or after the publication date of the print version.
Date of online availability
The date that a work was first made available online. This may be before or after the publication date.
Date of first open access
The date that a work was first made publicly available on an Open Access (OA) basis. For example, this could be the date that a copy of the work was made live (discoverable) on an OA basis on a repository or may be triggered when an embargo period expires. It could also be when an work was available on a publisher web site, or elsewhere, on an OA basis.
Date of end of embargo
Date after which deposited items become available to read and download on the web. The date of the last day of an embargo period.
Date of deposit
Date on which a copy of a version of a work and its metadata is deposited in a repository (or equivalent). Not necessarily the same as the date that the work becomes discoverable. A period of time may elapse after deposit, but before the record is made publicly available during which the record may be checked for accuracy and compliance by repository administration staff and an embargo may be applied.
Date of compliant deposit
Date on which a copy of a version of a work and its metadata is in a repository (or equivalent) and meets the requirements of a mandate, policy, piece of legislation etc.
Date of acceptance
The day on which the publisher or evaluation institution or committee confirms formally that the article has been received from the author and no substantial changes to the content are required. Also the date on which the publisher tells the author that the article will be published and the article is ready to be processed for publication.
Born open access
Commercial or non-profit publishers established for the sole purpose of publishing Open Access (OA) journals. They normally make use of the Creative Commons Attribution License for their publications. Authors usually retain their copyrights and users are needed to acknowledge and cite the authors in future references.
Access
The continued, available for use, ongoing usability of a digital resource, retaining all qualities of authenticity, accuracy and functionality deemed to be essential for the purposes the digital material was created and/or acquired for. Users who have access can retrieve, manipulate, copy, and store copies on a wide range of hard drives and external devices.
