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
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 <em>'the recorded factual material commonly accepted in the scientific community as necessary to validate research findings.'</em> 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 <a href='/dictionary/term/data-management-plan-dmp'>data management plan (DMP)</a> 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 <a href='/pillar/rdm'>research data management (RDM)</a> 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
A revised version of the original project plan, reflecting approved changes to scope, work packages, milestones, deliverables, budget, or timeline, typically produced after a project pivot, change request, or extension.
Project plan
The structured document, typically created in the proposal or award-acceptance phase, describing the project's objectives, methods, work packages, tasks, milestones, deliverables, timeline, budget, team, and risks.
Project metadata
The structured descriptive data about a research project, including title, abstract, dates, funder, award number, PI, contributors, institutions, scope, keywords, outputs, and identifiers (RAiD, ORCID, ROR, DOI), used for discovery, reporting, and linkage.
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
The explicit planning, typically conducted late in execution and at closeout, for the long-term stewardship, accessibility, and re-use of project outputs (data, software, publications, prototypes, networks) beyond the project's funded lifetime.
Post-project sustainability
The planning and provision for ongoing maintenance, hosting, support, or further development of project outputs (software, datasets, networks, services, communities) after the funded project has formally ended.
Lessons learned
A structured retrospective summary of what worked well, what did not, and what the project team would do differently, captured at major lifecycle milestones (especially 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.
Offboarding (project)
The structured process of transitioning a team member out of a project, including knowledge transfer, data and code hand-off, access revocation, exit interview, and documentation of outstanding items.
Onboarding (project)
The structured process of integrating a new team member, partner, or contributor into a project, including orientation to scope, methods, tools, data, governance, and team norms.
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 formal determination, typically at the end of a reporting period, of whether to continue funding the next budget period of a multi-year grant, based on satisfactory progress and continued funding availability.
Suspension (grant)
The temporary halting of a grant's activities, typically initiated by the sponsor in response to a concern (compliance, ethical, or financial), during which new obligations cannot be incurred against the award and previously incurred costs may be at risk.
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)
A formal extension of the project's period of performance beyond the original end date, with no additional sponsor funds, used to complete the funded scope when execution has been delayed or remaining funds support continued work.
Change request (project)
A formal request submitted to a sponsor to amend an aspect of an awarded project, such as scope, budget allocation, personnel, equipment, or timeline, typically requiring sponsor review and approval before the change takes effect.
Project pivot
A substantive change in the direction, methods, scope, or objectives of a research project, motivated by new findings, external developments, technical obstacles, or strategic re-evaluation, typically requiring formal sponsor approval.
End-of-project review
A formal review held at or near the end of the project's period of performance, assessing overall achievement of objectives, deliverables produced, impact, and lessons learned.
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 scheduled formal review of project progress conducted at a defined intermediate point in the project lifecycle, typically combining sponsor, consortium, and (sometimes) independent expert evaluation.
Annual report (grant)
A scheduled interim report submitted to the sponsor once per project year, summarising progress, deliverables, expenditure, personnel, and any deviations, supporting continuation decisions for multi-year awards.
Archive phase
The post-closeout lifecycle phase during which project records, datasets, code, and documentation are deposited in appropriate repositories for long-term preservation, access, and possible re-use.
Reporting phase
The lifecycle phase or sub-phase during which scheduled progress and financial reports are prepared and submitted to the sponsor, typically overlapping with later execution and closeout.
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 lifecycle phase between sponsor decision to fund and start of the period of performance, covering notification, negotiation of terms, contracting, ethics and other compliance approvals, and project mobilisation.
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 complete sequence of phases through which a research project progresses from initial idea through proposal, award, execution, reporting, closeout, and post-project legacy.
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.
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.
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 can be discovered, accessed and reused by those other than the author(s); often defined or clarified by means of permissions, terms and conditions, or a license.
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
Date the work is made available to the public by a publisher.
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.
