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Glossary of Terms

A   B   C   D   E   F   G   H   I   J   K   L   M   N   O   P   Q   R   S   T   U   V   W   X   Y   Z  

 A

  
Definition
Administering Research Governance (RG) Office

​The RG Office that is nominated by the CPI to process the Create Project form.  This RG Office should be responsible for a site where the CPI intends to conduct the project.

Adverse Device Effect (ADE)

​Adverse event related to the use of an investigational medical device.

Adverse Event (AE)

IMP: ​Any untoward medical occurrence in a patient or clinical trial participant administered a medicinal product and that does not necessarily have a causal relationship with this treatment.

IMD: Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in participants, users or other persons, whether or not related to the investigational medical device.

Adverse Reaction (AR)

​Any untoward and unintended response to an investigational medicinal product related to any dose administered.

Alternative Review Committee (ARC)

​A subcommittee or alternative review process constituted under the Human Research Ethics Committee (HREC) to expedite the review of low and negligible risk research.

Amendment

A written description of a change(s) to or formal clarification of a protocol or research project.

Application Closing Date (ACD)

​The last date that the Ethics Office will accept the submission of ethics applications for review at the next Human Research Ethics Committee (or subcommittee) meeting.

Approval Decision Date

In the Forms & Documents tab: in Ethics Approval, this is the ethics approval date. In Site Authorisation, this is the site authorisation date.

Associate Investigator (AI)

An Associate Investigator at a site who is not the PI but is a named investigator on the research project. The AI is also known as the Assistant Investigator, Sub-investigator, Co-investigator/Researcher.

 B

  
Definition
Biobank

​An organised collection of human biological material and any related information stored for one or more purposes.

Biological

​An item made from, or containing, human cells or human tissues, and that is used to treat or prevent disease or injury, diagnose a condition of a person, alter the physiological processes of a person, test the susceptibility of a person to disease, replace or modify a person's body part(s).

Business Manager (BM)

Person responsible for the financial managment of the research department. Reviews the budget to ensure that the costs that impact on the site is accurately reflected and funding for services and resources are identified and agreed to.

 C

  
Definition
Certified Human Research Ethics Committee (HREC)

​A HREC hosted by an insitution which has had its processes assessed and certified under the National Health and Medical Research Council (NHMRC) National Certification Scheme.

Chief Executive (CE)

A person that is the Chief Executive of the organisation or has delegated authority. The CE decides whether site authorisation should be given to a project, based on the HREC and research governance reviews, at a site to which they have responsibility.

Clinical Trial

​Any research project that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.

Clinical Trial - Phase 0

​Includes exploratory, first-in-human trials. Phase 0, as a category for clinical trials, has become increasingly common and described research studies also referred to as pilot studies or exploratory investigational drug (IND) studies.

Phase 0 trials are also known as human micro-dosing studies and are designed to speed up the development of promising drugs or imaging agents by establishing very early on whether the drug or agent behaves in human subjects as was anticipated from preclinical studies. Exploratory trials are conducted before traditional dose escalation and safety studies and gives no data on safety or efficacy, being by definition a dose too low to cause any therapeutic effect.

Clinical Trial - Phase 1

Includes initial study to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients. Trials are often dose ranging/escalating trials, which are done to determine the maximum dose of a new medication that can be safely given to a patient.

Clinical Trial - Phase II

Once the initial safety of the study drug has been confirmed in Phase I trials, Phase II trials are performed on larger groups (20-300) and are designed to assess how well the drug works, as well as to continue Phase I safety assessments in a larger group of volunteers and patients. When the development process for a new drug fails, this usually occurs during Phase II trials when the drug is discovered not to work as planned, or to have toxic effects.

Some trials combine Phase I and Phase II, and test both efficacy and toxicity.

Clinical Trial - Phase III

​Phase III trials include expanded controlled and uncontrolled trials after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of a new drug/medication or intervention, including possible adverse reactions.

It is also to provide an adequate basis for physician labelling.

Clinical Trial - Phase IV

Post-marketing study sometimes required by a drug safety agency (e.g. the TGA or US FDA). Phase IV trials are done to monitor the toxicity, risks, utility, benefits and optimal use after the efficacy of the drug/medication or intervention has been proven.

Commercial Trial

​A commercial trial is one that is funded and sponsored by a commercial company, where the company designs the protocol and owns the results and intellectual property rights arising from the trial.

Committee Member (CM)

Role allocated to a person that has been appointed to a position on a WA Health HREC or their affiliated subcommittees.

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 D

  
Definition
Data Safety Monitoring Board (DSMB)

​A multidisciplinary group established by the trial sponsor to review, at intervals, accumulating trial data, in order to monitor the progress of a clinical trial.

Declaration of Confidentiality (DoC)

​A declaration form that is signed by non-WA Health employees when they are invited to be a project member to ensure WA Health participants and their data is kept confidential.

Department

​The area within a site that is either conducting the research or providing support services. Departments usually operate under the authority of a Head of Department. 

Deviation

​Any divergence or departure from the requirements of Good Clinical Practice or the clinical trial protocol.

Device Deficiencies

​Inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety or performance.

Division

​A group of departments within a site, that operates under the authority of a Divisional Director.

Divisional Director (DD)

A person with responsibility for the Division intending to conduct a research project. Responsible for reviewing the project to ensure that the services and resources are adequate to conduct the research project within the Division. Also know as Co-Director.

Documents

​Ethics (e.g. participant consent form) or Governance (e.g. contracts) PDF or DOC/DOCX (Word) documents are part of the ethics or governance application. They are usually associated with an ethics (e.g. WAHEAF) or governance (e.g. SSA) application form.

 E

  
Definition
Ethics Executive Officer (EEO)

A person that has been appointed to an administrative position within a WA Health Ethics Office. The person provides administrative support and advice on the HREC, its subcommittees and the sponsoring institution's processes for ethical review of research projects conducted under the HREC's approval.

 F

  
Definition
Finish Date
The date when no further contact with participants/data source is foreseen including the data analysis and reporting period.
First Participant Recruited

​The date the first eligible participant is consented to the research project.

Forms

​Ethics (e.g. WAHEAF) or Governance (e.g. SSA) forms which are part of the ethics or governance application. They are usually supported by additional ethics (e.g. participant consent form) and governance (e.g. contracts) documents.

 G

  
Definition
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 H

  
Definition
Head of Research Department (HoD)

A person that is the Head of Department within an organisation where the research project will be conducted i.e. the department which is spearheading the project at a site. Responsible for reviewing the project's feasibility to be conducted it within their department based on the resources, services, costs and funding outlined in the budget.

Head of Supporting Department (HoSD)

A person that is the Head of a Supporting Department within an organisation where the project will be conducted i.e. the department which is providing resources or services to support the project. Responsible for providing information and estimated costs in the budget, for their department to provide resources and/or services required for the conduct of the project.

Health Service Provider

​Health Service Provider means a health service provider established under s. 32 of the Health Services Act 2016 and may include North Metropolitan Health Service (NMHS), South Metropolitan Health Service (SMHS), Child and Adolescent Health Service (CAHS), WA Country Health Service (WACHS), East Metropolitan Health Service (EMHS), Quadriplegic Centre and Health Support Services (HSS).

Hospital Administrator (HA)

A person, who is appointed to, or acting in, a position within the organisation that has to decide whether to provide resources or services to support a research project; or authorise the commencement of a project at a site. This may involve one or more of the following: 

  • Provision of information, including quotes, for departmental resources and/or services to enable the development of a budget for a project.
  • Provision of either an authorisation or decline decision to provide departmental resources and/or services for a project on the governance application and budget.
  • Review and decide whether to provide authorisation to conduct a project within a department or at a site.

This person can be a Data Custodian, Data Steward, Head of Research Department (HoD), Head of Supporting Department (HoSD), Business Manager (BM), Divisional Director (DD), Regional Director (RD ) or Chief Executive (CE).

Human Research Ethics Committee (HREC)

​An institutional body (committee) that has been established in accordance with the NHMRC National Statement on Ethical Conduct in Human Research and conducts the scientific and ethical review of research.

 I

  
Definition
Investigational Medical Device (IMD)

​Medical device being assessed for safety or performance in a clinical investigation.

Investigational Medicinal Product (IMP)

​A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorisation when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, a new patient group or when used to gain further information about an approved use.

Investigator Brochure (IB)

​IMD: Compilation of the current clinical and non-clinical information on the investigational medical device(s) relevant to the clinical investigation.

IMP: The document containing a summary of the clinical and non-clinical data relating to an investigational medicinal product that are relevant to the study of the product in humans.

 J

  
Definition
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 K

  
Definition
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 L

  
Definition
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 M

  
Definition
Medical Device

Any instrument, apparatus, implement, machine, appliance, implant, software, material or other similar or related article:

a. intended, by the person under whose name it is or is to be supplied, to be used for human beings for the purpose of one or more of the following:

diagnosis, prevention, monitoring, treatment or alleviation of disease; diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap; investigation, replacement or modification of the anatomy or of a physiological process; supporting or sustaining life; control of conception; disinfection of medical devices, and

b. that does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but that may be assisted in its intended function by such means.

Monitoring

​The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), GCP, and the applicable regulatory requirement(s).

 N

  
Definition
Non-Commercial Trial

​A non-commercial trial is one where a non-commercial (not for profit) organisation retains control of the protocol and is the trial sponsor. Non-commercial trials are usually publically funded (e.g. by government/charities), but may also be funded/supported by a commercial company.

 O

  
Definition
Overhead Charge

​This charge should be applied in accordance with the Financial Managment Manual to research department salary costs. The overhead charge cover indirect costs to the specialty/organisation including rent, building maintenance & utilities, support personnel and departmental charges, equipment maintenance & IT infrastructure.

 P

  
Definition
Principal Investigator (PI)

The person responsible, individually or as a leader of the research team at a site, for the conduct, management and reporting related to the research project for that site and reports to the CPI. In a single centre project, the PI may also be the CPI.

Product Information

​The approved Australian summary of the scientific information relevant to the safe and effective use of a prescription medicine.

Note: In a trial in which the IMP is an approved product, the Product Information may replace the investigator's brochure. If the conditions of use differ from those authorised, the Product Information should be supplemented with a summary of relevant clinical and non-clinical data that supports the use of the IMP in the trial. The Australian Product Information should be used where available for each trial IMP adopted across Australian sites.

Protocol

​A document that describes the objective(s), design, methodology, statistical considerations, and organisation of a project. The protocol usually also gives the background and rationale for the project, but these could be provided in other protocol referenced documents.

Public Health Organisation (PHO)

​In Western Australia this is the WA health system. The WA health system is comprised of the Department of Health, Health Service Providers (NMHS, SMHS, CAHS, WACHS, EMHS, Quadriplegic Centre and HSS) and to the extent that contracted health entities provide health services to the State, the contracted health entities.

 Q

  
Definition
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 R

  
Definition
Reference Safety Information (RSI)

​The information contained in either an investigator's brochure or an approved Australian Product Information (or another country's equivalent) that contains the information used to determine what adverse reactions are to be considered 'expected adverse reactions' and on the frequency and nature of those adverse reactions.

Regional Director (RD)

A person that has is a Regional Director, within WA Country Health Services (WACHS), with responsibility for the site(s) where the research project will be conducted. Responsible for reviewing the project to ensure that the services and resources are adequate to conduct the research project within the Region.

Research Department

The department in which the research project will be conducted i.e. the department which is spearheading the project at a site. 

Research Governance

​A process used by an organisation for the oversight, assessment, authorisation and monitoring of research conducted at one or more of its sites or under its auspices. A research governance framework includes good research culture and practice, organisational strategy, role definition and accountabilities, risk, resource and financial assessment and management, compliance with legal, regulatory and contractual requirements, competencies and training of personnel, site assessment, scientific review, ethical review and approval, site authorisation, monitoring of research, and management of conflicts of interest, complaints and allegations of research misconduct.

Research Governance Office (RG Office)

​An office within a public health organisation established to undertake research governance on behalf of sites within the public health organisation. 

Research Governance Officer (RGO)

A person that has been appointed to an administrative position within a WA Health RG Office. This person is responsible for reviewing the forms and supporting documents related to governance applications and administers site authorisation documentation. The RGO provides recommendation for site authorisation to the CE or Delegate.

Research Governance Service (RGS)

RGS supports the research governance framework for all human research conducted within WA Health or accessing WA Health participants, their tissue or data.

The RGS is a centralised IT system for investigators, project members, sponsors, Hospital Administrators/sites, Human Research Ethics Committees & Research Governance Offices to complete, submit, administer, track and report on ethics and governance documentation throughout the lifecycle of a project, including authorisation, monitoring, closure and publications.

Research Group Member (RGM)

​This is default membership given to anyone invited to the project as a Project Member who has not been given a project specific role.  Within RGS they can provide information and edit project forms and upload supporting documents to which the y are assigned according to their security and access rights.

Review Decision Date

​The date the HREC or RGO makes a decision on their review of the valid ethics or governance application respectively.  

RGS Administrator

​This is a business administrative role within RGS to assist users with business support, including user managment and organisational structures. The person may hold additional administrative roles within RGS at the same time, such as EEO or RGO.

 S

  
Definition
Safety Critical Adverse Events

​Adverse events and/or laboratory abnormalities identified in the protocol as critical to safety evaluation that should be reported to the sponsor according to the reporting requirements specified in the protocol.

Serious Adverse Device Effect (SADE)

​An adverse device effect that has resulted in any of the consequences characteristic of a serious adverse event.

Serious Adverse Event (SAE) for IMD

​Adverse event that:

a. led to death

b. led to serious deterioration in the health of the participant, that either resulted in: a life-threatening illness or injury; or a permanent impairment of a body structure or a body function; or in-patient or prolonged hospitalization; or medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function

c. led to foetal distress, foetal death or a congenital abnormality or birth defect.

Serious Adverse Event (SAE)/Serious Adverse Reaction (SAR) for IMP

​Any adverse event/adverse reaction that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect.

Serious Breach

​A breach that is likely to affect to a significant degree:

  • The safety or rights of a  participant
  • The reliability and robustness of the data generated in the project.
Significant Safety Issue (SSI)

​A safety issue that could adversely affect the safety of participants or materially impact on the continued ethical acceptability or conduct of the trial.

Site

The location(s) where reserch project-related activities are actually conducted. Where the research will be conducted at more than one location within the same institution, this should normally be considered as a single site. Interchangeably termed as 'Organisation'.​

Sponsor

​This is the designated representative of an entity that provides funding for a research project. The sponsoring organisation may be a pharmaceutical/technology company, a Contract Research Organisation (CRO), collaborative research group, a higher education institution, a research institute, or the health or medical organisation where the research is to take place.  The Sponsor can assist with the completion of the ethics application forms and supporting documents. 

Start Date

​The first point of recruitment i.e. the date when the advertising or screening for participants can begin.

Subcommittee (SC)

A committee constituted under the Human Research Ethics Committee (HREC) that is responsible for the scientific or expedited review of projects on behalf of the HREC.

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 T

  
Definition
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 U

  
Definition
Unanticipated Serious Adverse Device Effect (USADE)

​Serious adverse device effect which by its nature, incidence, severity or outcome has not been identified in the current version of the risk analysis report

Note: Anticipated serious adverse device effect (ASADE) is an effect which by its nature, incidence, severity or outcome has been identified in the risk analysis report.

Unexpected Adverse Reaction (UAR)

​An adverse reaction, the nature or severity of which is not consistent with the Reference Safety Information (RSI).

Urgent Safety Measure (USM)

​A measure required to be taken in order to eliminate an immediate hazard to a participant's health or safety.

Note: This type of significant safety issue can be instigated by either the investigator or sponsor and can be implemented before seeking approval from HRECs or institutions.

 V

  
Definition
Validation Date

​The date the EEO or RGO validates the ethics or governance application respectively following submission. Validation checks that the submitted forms and documents are correct prior to review by a HREC or RGO.

 W

  
Definition
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 X

  
Definition
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 Y

  
Definition
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 Z

  
Definition
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