Technology
Acceptable use
The authorized and appropriate utilization of corporate devices in accordance with PVR policy and other corporate guidelines.
HR
Accountable person
Responsible to ensure that a task or an objective (or another activity) is performed and that the results are achieved, but not necessarily for personally taking the relevant action/s
Clinical operations
Adverse event (AE)
Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, symptom, or disease temporally associated with the use of an investigational product, whether or not related to the medicinal (investigational) product.
Clinical operations
Agreement
A written, dated, and signed agreement between two or more involved parties that sets out any arrangements on delegation and distribution of tasks and obligations and, if appropriate, on financial matters. The protocol may serve as the basis of a contract.
Quality
Agreement (AGRMNT)
A standard wording for various contracts/agreements such as confidentiality agreements, service agreements, quality agreements. The wording may be changed through negotiations with the third party. If applicable ensure that legal is involved.
Patient service operations
AHN
At home nursing.
Legal and Compliance
Applicable laws
All applicable anti-bribery laws, including the FCPA, the UKBA, and the local laws in every country in which PVR does business. Bribery is prohibited in all countries with operations. These laws generally prohibit both bribery of government officials and private sector (commercial) bribery.
Patient service operations
At home nursing project
Any project whereby healthcare is the dominant service.
Quality
Approver
An employee with the final authority to approve the QMS document. The approver's signature allows the QMS document to come into effect when the effective date is reached.
HR
Assigned employees
Responsible to ensure that a task or an objective (or another activity) is performed and that the results are achieved, but not necessarily for personally taking the relevantThe employees who have been assigned to complete the training and, if applicable, the knowledge assessment. action/s
Quality
Author
An employee who is the main developer of the QMS document. Any employee whom writing is delegated to by the owner, based on thorough experience and knowledge of the business function.
Legal and Compliance
Automated Decision-Making (ADM)
When a decision is made which is based solely on Automated processing (including profiling) which produces legal effects or significantly affects an individual. The UK GDPR prohibits Automated Decision-Making (unless certain conditions are met) but not Automated processing.
Technology
Backup copy
Any copy of the data that has no other purpose than to provide a restoration capability if the original operational version of the data was damaged or lost.
Quality
BD
Business development.
Clinical operations
Biological samples (Biosamples)
Blood, fluid and/or tissue samples collected from trial subjects as may be outlined in the Protocol and tangible materials directly or indirectly derived from such samples.
Clinical operations
Blinding
A procedure in which one or more parties involved in the conduct of a clinical trial are unaware of the treatment assignment(s).
Patient service operations
Booking initiator
Retrieving data. Wait a few seconds and try to cut or copy again.
Patient service operations
Booking request
The request provided by the principal investigator manually or through a system used by the client/sponsor.
Patient service operations
Booking request
The request provided by the principal investigator manually or through a system used by the client/sponsor.
Marketing
Brand book
A document that delineates a company's brand identity guidelines, standards, and specifications. Its purpose lies in fostering uniformity and cohesion in how the company portrays itself visually and through its messaging to the public.
Marketing
Brief
A document that outlines the objectives, scope, and requirements of a marketing research project and helps ensure that the research is focused, and aligned with the initiator's goals and objectives.
Quality
Business area
A separate organizational location in PVR which has its own distinct set of processes.
Patient service operations
Business development
Any PVR employee who receive a request for new project start-up.
Quality
Business function
The set of processes performed within a specific business area. A function shall have the same name as the business area where it is performed.
Finance
Business trip
Travel that is undertaken for business purposes by an employee during a designated period to another locality to complete a specific business objective(s) and responsibilities according to the job description, away from the permanent job location.
Quality
CAO
Chief administrative officer
Quality
CAPA
Corrective- and preventive action
Clinical operations
Case report form (CRF)
A printed, optical, or electronic document designed to record all of the protocol-required information to be reported to the sponsor on each trial subject.
Patient service operations
Central laboratory
Facility that conducts the analysis or evaluation of samples collected as part of a clinical trial or treatment scheme; such analysis or evaluation may include the generation of pharmacokinetic data, safety data, primary efficacy data, histopathology data or data used to support any other stated end point. Laboratories may be: independent laboratory or of contract research organizations, part of the sponsor’s organization or part of a hospital or academic institution.
Legal and Compliance
CEO
Chief executive officer
Patient service operations
Central laboratory
Facility that conducts the analysis or evaluation of samples collected as part of a clinical trial or treatment scheme; such analysis or evaluation may include the generation of pharmacokinetic data, safety data, primary efficacy data, histopathology data or data used to support any other stated end point. Laboratories may be: independent laboratory or of contract research organizations, part of the sponsor’s organization or part of a hospital or academic institution.
Clinical operations
Certified translator
The company employee or contractor whose language capabilities are demonstrated by possession of a certificate, diploma or university degree in a language other than their native language. A copy of the relevant certificate or diploma, or the translator’s CV which documents these academic qualifications, should be obtained, and filed.
Quality
Change
Any modification of a validated/an approved procedure, or system, that may affect the quality and/or safety due to the changes.
Quality
Change control
A process that is used to ensure that changes are managed in a controlled and coordinated manner. Changes shall be identified, documented, be authorized and evaluated after implementation.
Quality
Change control implementer
An employee who shall manage the performance of the activities as per the implementation plan.
Patient service operations
Client
Is a person or company that receives agreed services from PVR according to signed agreement between the parties in return for payment.
Clinical operations
Clinical investigator manual
Includes procedures, instructions and guidelines for the investigators and clinical trial site personnel.
Patient service operations
Clinical trial site outreach
Introduce PVR to the clinical trial sites and invite for training
Clinical operations
Clinical research associate (CRA)
Part of the PVR quality team. Ensure compliance with the regulations, GCP and SOPs, by monitoring clinical trials. The CRA shall be the main contact with the site.
Clinical operations
Clinical trial
Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational product(s) with the object of ascertaining its safety and/or efficacy. The terms clinical trial and clinical study are synonymous.
Clinical operations
Clinical trial authorization (CTA)
Authorization to conduct a clinical trial granted by the competent authority.
Clinical operations
Clinical trial site
The location(s) where trial-related activities are conducted.
Clinical operations
Clinical trial data
Information as numerical or text values found within paper and electronic records (including images and sound) e.g. trial reports, case report forms, faxed documents, emails and attachments, trial databases, photographs and x-rays.
Clinical operations
Clinical trial samples
Any biological sample collected from a participant of a clinical trial as required by the protocol. Samples may include but are not limited to: blood, plasma, serum, urine, faeces, tissues and cells.
Clinical operations
Clinical trial site manual
Capture trial documents that are related to the protocol, key subject documentation such as the ICF, questionnaire, diary, participation card and other patient documents.
Clinical operations
Clinical trial site identification
Trial site number which is allocated by project manager or sponsor.
Clinical operations
Clinical trial site personnel
Personnel employed or contracted by the principal investigator and listed on the clinical trial personnel delegation log who are performing clinical trial related activities.
Legal and Compliance
Commercial bribery
Giving, promising, offering, or providing corrupt payments and other advantages to or accepting the same from private (non-government) persons and entities, including kickbacks.
Quality
Company personnel
All employees, workers, contractors, agency workers, consultants, directors, members, and others.
Quality
Complaints
A non-conformity reported by an external party/client
Clinical operations
Compliance (in relation to clinical trials)
Adherence to all the clinical trial-related requirements, Good Clinical Practice (GCP) requirements and the applicable regulatory requirements.
Clinical operations
Confidentiality (in relation to clinical trials)
Prevention of disclosure, to other than authorized individuals, of a sponsor's proprietary information or a subject's identity.
Legal and Compliance
Conflict of interest
A situation in which a person or organization is involved in multiple interests, financial or otherwise, and serving one interest could involve working against another.
Clinical operations
Contract research organization (CRO)
A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor's trial-related duties and functions.
Legal and Compliance
Controller
The person or organisation that determines when, why and how to process personal data. It is responsible for establishing practices and policies in line with the UK GDPR. We are the controller of all personal data relating to our Company Personnel and personal data used in our business for our own commercial purposes.
Patient service operations
Coordination
A set of activities carried out by the patient service coordinator shortly after receiving a booking. Such activities include communicating with the vendor/s and placing proper orders for the purpose of organizing of biosamples logistics and export procesess.
Patient service operations
Coordination activities
Activities include communicating with the subject and the approved vendor/s to deliver appropriate service as per service requests and support the subjects for the proper fulfilment of the booking request. Contacting the subject throughout the trip on pre-defined milestones is also an integral part of coordination, if applicable.
Technology
Corporate devices
Any electronic devices provided by the PVR for work-related purposes, including but not limited to laptops, desktop computers, mobile phones, tablets, and other portable devices.
Marketing
Corporate language
American English
Quality
Corrective action
Retrieving data. Wait a few seconds and try to cut or copy again.
Legal and Compliance
Counterparty
The client or the vendor who sign the document with PVR.
Patient service operations
Courier/approved vendor
Approved local vendor for shipments delivery (refer to approved vendor list FORM-PSOPS-018, "Vendor catalog")
Legal and Compliance
Criminal convictions data
Personal data relating to criminal convictions and offences, including personal data relating to criminal allegations and proceedings.
Clinical operations
CSF
Country specific file.
Quality
CTO
Chief technology officer.
Clinical operations
Curriculum Vitae (CV)
A summary of a person’s education and qualification, professional history, and job qualifications.
Technology
Data encryption
The process of converting data into a form that cannot be easily understood by unauthorized individuals.
Legal and Compliance
Data Privacy Impact Assessment (DPIA)
Tools and assessments used to identify and reduce risks of a data processing activity. A DPIA can be carried out as part of Privacy by Design and should be conducted for all major system or business change programmes involving the processing of personal data.
Data Protection Officer (DPO): either of the following:
a) the person required to be appointed in specific circumstances under the UK GDPR; or
b) where a mandatory DPO has not been appointed, a data privacy manager or other voluntary appointment of a DPO or the Company data privacy team with responsibility for data protection compliance.
Legal and Compliance
Data subject
A living identified or identifiable individual about whom we hold personal data. data subjects may be nationals or residents of any country and may have legal rights regarding their personal data.
Clinical operations
Direct access
Permission to examine, analyze, verify, and reproduce any records and reports that are important to the evaluation of a clinical trial. Any party (e.g., domestic and foreign regulatory authorities, sponsor's monitors and auditors) with direct access should take all reasonable precautions within the constraints of the applicable regulatory requirement(s) to maintain the confidentiality of subjects' identities and sponsor’s proprietary information.
Quality
Direct manager
The employees direct line manager, supervisor, or team leader responsible for the management of the employee, unless an alternative is specified.
Finance
Direct manager
The employee's direct line manager, supervisor or team leader who is responsible for the management of the employee unless an alternative is specified.
HR
Disciplinary
Processes, policies, and actions related to managing employee behavior and performance in accordance with the organization's rules, regulations, and expectations.
Quality
Division
A business area in PVR wA business area in PVR reporting directly to the CEO in the hierarchy.hich is directly below the CEO in the hierarchy.
Legal and Compliance
Document
Any document that shall be signed between PVR and client/vendor/employee and may be contract/agreement/work order/task order/price list/amendment/appendix to an agreement.
Legal and Compliance
Document owner
An employee from LECOMP or QUAL who is responsible for the upload of the document for signature via SignNow/DocuSign and who shall keep a copy of the final signed electronic document and shall request a scanned copy of all wet ink documents for electronic filing.
Administration
Document flow
A process of maintenance of documents within the company.
Clinical operations
Documentation
All records, in any form (including, but not limited to, written, electronic, magnetic, and optical records, and scans, x-rays, and electrocardiograms) that describe or record the methods, conduct, and/or results of a trial, the factors affecting a trial, and the actions taken.
Patient service operations
DFS
Introduce PVR to the clinical trial sites and invite for training.
Patient service operations
DoA
Delegation of authority.
HR
Drugs
A medicine or other substance which has a physiological effect when introduced into the body.
Clinical operations
DSUR
Direct from subject.
HR
Electronic signing system
An electronic system used for electronic signature which is CFR21 part 11, compliant.
Legal and Compliance
Employee
Any person performing a role as per PLCY-EXEC-001.01 " PVR culture" and who is affiliated with PVR via an employment agreement or another agreement that clearly defines the role and related responsibilities.
Patient service operations
ERP
Enterprise resource planning system. A management system used to track booking requests.
Clinical operations
Essential documents
Documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced.
Clinical operations
EudraCT
European Union drug regulating authorities clinical trials database.
Legal and Compliance
Explicit consent
Consent which requires a very clear and specific statement (that is, not just action).
Marketing
External communication
The exchange of information, messages, or data between a company or organization and individuals, entities, or stakeholders outside of its immediate structure.
Quality
External audit
An audit performed by an external party which can be planned or unplanned.
Marketing
External parties
Entities, individuals, or organizations that are not directly part of the internal structure of a company or organization.
Quality
External resource documents
A resource document which is not a PVR QMS document.
Marketing
E-mail correspondence
The written exchange of messages and information between individuals or parties using electronic mail (e-mail).
Finance
Finance person
An employee of a financial unit or person provides outsourced accounting services for PVR.
Quality
Functional responsible party
A responsible party that is a function and not an employee. Mid or high-level processes may include functional responsible parties.
Quality
Form (FORM)
A form is a document which includes various tools, allowing the recording of information that is required when performing a process described in a standard operating procedure or a work instruction. A form shall always be subordinate to a standard operating procedure or a work instruction. Forms shall be available in Excel and Word format for use.
Clinical operations
Food and Drug Administration (FDA)
Agency of the U.S. federal government authorized by Congress to inspect, test, approve, and set safety standards for foods and food additives, drugs, chemicals, cosmetics, and household and medical devices.
Patient service operations
GCP
Good clinical practice.
Legal and Compliance
Global legal document
A document that shall be signed by PEOPLE VALUE RESEARCH LTD (UK company).
Quality
Good Documentation Practice (GDocP)
A set of best practices for documentation and record keeping. It aims to preserve the data integrity of important documents and records and can also serve as guidelines for how to record information and store data appropriately.
Clinical operations
Good Clinical Practice (GCP)
A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that assures that the data and reported results are credible and accurate and that the rights, integrity, and confidentiality of trial subjects are protected.
Quality
Good Manufacturing Practice (GMP)
A set of Is the aspect of quality assurance that ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the product specification.best practices for documentation and record keeping. It aims to preserve the data integrity of important documents and records and can also serve as guidelines for how to record information and store data appropriately.
Legal and Compliance
Government bribery
Giving, promising, offering, or authorizing payment of anything of value to any government official to obtain or retain business, to secure some other improper advantage, or to improperly influence a government official’s actions.
Quality
Guideline (GDLN)
A set of rules or instructions or principles that are given by an official organization guiding employees how to do something, especially something difficult.
Patient service operations
GxP
Good documentation/clinical practices.
Patient service operations
Head of division
An employee performing a role of head of division as per SOP-EXEC-001"Organizational structure and culture" and who is affiliated with PVR via an employment agreement or another agreement that clearly defines the role and related responsibilities.
Patient service operations
HHCP
Home healthcare provider.
HR
HR
Human resource.
Clinical operations
The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use.
ICH
Clinical operations
Identifier
European Medicines Agency, the U.S. Food and Drug Administration or local regulatory authority number.
Clinical operations
Insured
Subject consented to participate in a clinical trial.
HR
HR
Human resource.
Patient service operations
Immediate dismissal
A misconduct that is considered so serious that dismissal is justified without any previous warnings.
Quality
Implementation plan
A plan created by quality and the owner to effectively implement the planned change. It is a combination of strategy, process, and action.
Quality
International Organization for Standardization (ISO)
Is an international standard development organization composed of representatives from the national standards organizations of member countries. Membership requirements are given in Article 3 of the ISO Statutes.
Quality
Internal audit
A plan created by quAn audit performed by the quality division as per internal audit plan, or unplanned, to evaluate the adherence to the QMS system, to add value and improve an organization's operations.ality and the owner to effectively implement the planned change. It is a combination of strategy, process, and action.
Marketing
Internal communication
The sharing of information among members of the organization, and can be vertical, horizontal, or diagonal communication, includes:
• personal contact which includes meetings and training
• telephone conversations
• e-mails
• text messages
• Microsoft Teams messages and calls
Marketing
Internal parties
All employees.
Quality
Incident
Single or a series of unwanted or unexpected events that have a significant probability of compromising the safety of patients/employees or the outcome of the procedure/service.
Clinical operations
Independent Ethics Committee (IEC)
An independent body (a review board or a committee, institutional, regional, national, or supranational), constituted of medical professionals and non-medical members, whose responsibility it is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial and to provide public assurance of that protection, by, among other things, reviewing and approving/providing a favorable opinion on, the trial protocol, the suitability of the investigator(s), facilities, and the methods and material to be used in obtaining and documenting informed consent of the trial subjects.
Clinical operations
Informed consent Form (ICF)
A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject's decision to participate. Informed consent is documented by means of a written, signed and dated informed consent form.
Quality
Initiator
An employee who initiates an activity, e.g., QMS document development, vendor onboarding, change control, non-conformity, etc.
Clinical operations
Institution (medical)
Any public or private entity or agency or medical or dental facility where clinical trials are conducted.
Clinical operations
Institutional review board (IRB)
An independent body constituted of medical, scientific, and non-scientific members, whose responsibility is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial by, among other things, reviewing, approving, and providing a continuing review of the trial protocol and amendments and of the methods and material to be used in obtaining and documenting informed consent of the trial subjects.
Quality
Internal resource document
A PVR QMS document.
Clinical operations
Investigational products (IP)
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 authorization when used or assembled (formulated or packaged) in a way different from the approved form, when used for an unapproved indication, or when used to gain further information about an approved use.
Clinical operations
Investigator
A person who is responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator.
Clinical operations
Investigator site file (ISF)
A standard filing system which allows the effective storage and location of essential documents related to an individual trial site.
Clinical operations
Investigator's brochure (IB)
A compilation of the clinical and nonclinical data on the investigational product(s) which is relevant to the study of the investigational product(s) in human subjects.
Quality
Jira
A software application used that allows tracking, planning, project management and automated workflows.
Patient service operations
Key performance indicators (KPI)
Well-defined criteria that enable the measurement of service level, determining whether performance level expectations per each material step are met or unmet, as well as quantifying the degree of meeting or not meeting such performance-level expectations.
Clinical operations
Laboratory
A facility that conducts the analysis or evaluation of samples collected as part of a clinical trial; such analysis or evaluation may include the generation of pharmacokinetic data, safety data, primary efficacy data, histopathology data or data used to support any other stated end point. Laboratories may be: independent contract research organisations, part of the sponsor’s organisation or part of a hospital or academic institution.
Clinical operations
Laboratory kit (Labkit)
A set of components used to perform laboratory test specifically prepared as per protocol requirements.
Legal and Compliance
Local director
A person who is manager/director according to local corporate document and have authorization to sign the document on behalf of local PVR Company.
HR
Local law
Any applicable law or regulation is in force in the jurisdiction in which the Employee has employment relationships with PVR.
Legal and Compliance
Local PVR company
A company of PVR that is registered in a PVR location.
Clinical operations
Local regulatory authority
Independent governmental body established by legislative act in order to set standards in a specific field of activity, or operations, in the private sector of the economy and then to enforce those standards.
Quality
Management
Employees of the company, whose functions include making decisions about the organizational structure of the company, their objectives, setting objectives, and taking responsibility for the management of the company. The management includes the heads of divisions and units and the CEO.
Marketing
Market research
A document that outlines the objectives, scope, and requirements of a marketing research project and helps ensure that the research is focused, and aligned with the initiator's goals and The process of gathering and analyzing information about a market, including the consumers, competitors, and industry trends. May involve a variety of techniques, such as surveys, focus groups, interviews, and observation, and that can be used to inform decisions related to product development, pricing, promotion, distribution, and other aspects of marketing.
HR
Major misconduct
A conduct that is considered inappropriate to allow the employee to continue to work and the conduct itself is particularly serious or in its consequences. This may result in an immediate dismissal after a disciplinary hearing with the forfeiture of any notice.
HR
Minor misconduct
Minor breach of rules, regulations, and/or duties. It is sufficiently serious to warrant disciplinary action but in the first instance, the disciplinary consequence will be verbal warning. This minor misconduct is related to the standard of conduct or performance and not a repetition of an earlier misconduct.
Clinical operations
Misconduct and fraud (in clinical trials)
The fabrication, falsification plagiarism or deception in proposing, carrying out or reportingresults of research or deliberate, dangerous or negligent deviations from accepted practicesin carrying out research. It includes failure to follow established protocols or adhere toestablished ethical principles, if this failure results in unreasonable harm to human beings,other living organisms or the environment and facilitating of misconduct in research bycollusion in, or concealment of, such action by others. It includes intentional, unauthoriseduse, disclosure or removal of, or damage to, research-related property of another, includingapparatus, materials, writings, data hardware or software or any other substance or devicesused in or produced by the conduct of the clinical trial. It also includes any plan or conspiracy or attempt to do any of the above.
Clinical operations
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), Good Clinical Practice (GCP), and the applicable regulatory requirement(s) (ICH GCP Guidelines).
Clinical operations
Monitoring plan (MP)
A document that describes the strategy, methods, responsibilities, and requirements for monitoring the trial.
Technology
Multi-factor authentication (MFA)
An additional layer of security that requires users to provide multiple forms of authentication to access a system.
Patient service operations
Multiple-time purchase
Purchase of goods or services two or more times from one vendor.
Quality
NC
Non-conformity.
Quality
NCR
Non-conformity report.
Clinical operations
New clinical trial site
This shall be an additional clinical trial site, with a new location, new facilities which was assessed and approved by the sponsor to participate in the clinical trial. This does not refer to a clinical trial site name or address changes or prinicpal investigator change.
Quality
Non-compliance
Failure to adhere to an act or it's regulation.
Quality
Non-conformity
Any failure to meet a requirement, a standard or procedure. This term shall be used throughout the document and shall include non-conformities, incidents, and non-compliances.
Quality
Non-conformity owner
An employee identified by quality and the owner who shall be responsible for the timely investigation, mitigation, and completion of the non-conformity and if applicable CAPA.
Patient service operations
Non-disclosure agreement (NDA)
Confidentiality agreement.
Quality
Non-significant change
A change that considers a low probability to impact the quality and/or safety. and can be implemented without difficulty.
Quality
Non-specific responsible party
A responsible party that can be any employee who meets criteria as defined in a specific process.
Quality
Non-subordinate documents
A document referred to in a QMS document but is a subordinate (child) document to another parent document.
HR
Onboarding
The process of introducing a newly hired employee into the organization.
Patient service operations
One-time purchase
One-time purchase of goods or services with total amount less or equal 500.00 EUR.
Marketing
OoO
Out of office.
Technology
Out-of-cycle backup
An additional layer of security that requires users to provide multiple forms of authentication to access a system.
Quality
Owner
A head of a business function whereby the processes/es described in the QMS document are performed. The owner is accountable for the process/es.
Quality
On-site audit
An audit that is performed at the physical location of the auditee.
Quality
Parent document
A document that is found at the top of a hierarchy containing subordinate documents.
Technology
Password
An additional layer of security that requires users to provideA secret combination of characters used to authenticate each user's identity. multiple forms of authentication to access a system.
Technology
Password complexity
The requirement for passwords to include a mix of uppercase and lowercase letters, numbers, special characters.
Patient service operations
Patient service coordinator (PSC)
An employee who provides coordination activities which includes subject and vendor(s) communication, requests for specific services with clear instructions and use of approved vendors, tracking the activities from start to end, and contacting the subject throughout the trip on pre-defined milestones, if applicable.
Patient service operations
Patient support service
A customizable subject support service intended for subjects who take part in clinical trials. This service includes the organization, coordination, and administrative activities related to any of the service components.
Legal and Compliance
Personal data
Any information identifying a data subject or information relating to a data subject that we can identify (directly or indirectly) from that data alone or in combination with other identifiers we possess or can reasonably access. personal data includes special categories of personal data and Pseudonymised personal data but excludes anonymous data or data that has had the identity of an individual permanently removed. Personal data can be factual (for example, a name, email address, location or date of birth) or an opinion about that person's actions or behaviour and other data according to the legislation.
Legal and Compliance
Personal data breach
Any act or omission that compromises the security, confidentiality, integrity or availability of personal data or the physical, technical, administrative or organisational safeguards that we or our third-party service providers put in place to protect it. The loss, or unauthorised access, disclosure, or acquisition, of personal data is a personal data breach.
Patient service operations
PI
Principal investigator.
Quality
Policy (PLCY)
A policy is a strategic document and shall be declarative and include a high-level overall plan and specifying objectives. A policy shall demonstrate PVR’s compliance with laws, regulations, and industry standards. Policies shall be created in Word, portrait. The chief executive officer shall be the owner and approver of all policies.
Quality
Position
Refers to a status assigned to an individual in the organizational chart.
Quality
Preventive action
Action to eliminate the cause of a potential non-conformity or other potential undesirable situations and to prevent occurrence of non-conformity.
Patient service operations
Principal investigator/clinical trial site personnel
A person who is responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator.
Legal and Compliance
Privacy by design
Implementing appropriate technical and organisational measures in an effective manner to ensure compliance with the UK GDPR.
Legal and Compliance
Privacy guidelines
The Company privacy and UK GDPR-related guidelines provided to assist in interpreting and implementing this “Data Protection Policy” and Related Policies, available from your line manager from QMS.
Legal and Compliance
Privacy notices (also referred to as Fair processing Notices) or Privacy policies
Separate notices setting out information that may be provided to data subjects when the Company collects information about them. These notices may take the form of:
a) general privacy statements applicable to a specific group of individuals (for example, “Employee privacy notices” or the website privacy policy);or
b) stand-alone, one-time privacy statements covering processing related to a specific purpose.
Quality
Procedure
A comprehensive description of a process which includes framework, standards, principles, and guidelines as well as the process.
Quality
Process
Is a series of activities that produce an outcome.
HR
Process owner
The employee who is accountable for maintaining and improving (e.g., new vendor request) a particular process and is responsible for the outcomes of the process.
Patient service operations
Process owner
An employee who initiates a process / request of new vendor onboarding, orders services and directly communicates with the relevant vendor.
Quality
Process flow
A list of activities that:
•Constitute a process
•Arranged chronologically
•Specifies the responsible party for each activity.
Quality
Process step
Each activity within a process flow.
Quality
Process step class
There shall be two process step classes indicated in italic blue if applicable:
• Parallel
• Either/or
Legal and Compliance
Processing or process
Any activity that involves the use of personal data it includes obtaining, recording, or holding the data, or carrying out any operation or set of operations on the data including organising, amending, retrieving, using, disclosing, erasing or destroying it. processing also includes transmitting or transferring personal data to third parties.
Patient service operations
Project at PVR
Order/request by a client to provide extended services for a project/clinical trial such as patient support, at home nursing, bio samples logistics.
Patient service operations
Project manager, Patient service operations (PM)
An employee who is responsible for the coordination and organization of multiple aspects of patient support projects - from setup to closeout - ensuring high-quality delivery and meeting industry standards, budgets and deadlines, all whilst complying with international and national regulations and the requirements of the PVR quality management system.
Clinical operations
Project manager (PM)
Project manager, clinical research.
Patient service operations
Project instruction
Detailed, written instruction of activities/responsibilities of the PVR project team and client/sponsor within the project. Also can be provided by the client/sponsor with a different reference.
Patient service operations
Project instruction PSOPS
Order/reDetailed, written instruction of activities/responsibilities of the PVR project team and client/sponsor within the project. Also can be provided by the client/sponsor with a different reference.quest by a client to provide extended services for a project/clinical trial such as patient support, at home nursing, bio samples logistics.
Patient service operations
Project registry
A computerized system for storing, cataloging, and accessing the project information and documents.
Patient service operations
Project team
A computerInclude but not limited to business development responsible party, head of patient service operations, project manager, patient service coordinator.ized system for storing, cataloging, and accessing the project information and documents.
Clinical operations
Protocol
A document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial. The protocol usually also gives the background and rationale for the trial, but these could be provided in other protocol-referenced documents.
Quality
Protocol (PRTCL)
A protocol shall describe a procedure which includes a specific and defined aim (e.g., validation of a computerized system). It shall include the methodology and tools to achieve that aim, a process flow and a final report. Appendices may be included. A protocol shall not have subordinate documents. Protocols are available in Word/Excel format for use. Excel only to be used if necessary.
Clinical operations
Protocol amendment
A written description of a change(s) to or formal clarification of a protocol.
Clinical operations
Protocol number
Sponsor's protocol short name.
Clinical operations
Protocol title
Sponsor's protocol full name.
Legal and Compliance
Pseudonymisation or pseudonymised
Replacing information that directly or indirectly identifies an individual with one or more artificial identifiers or pseudonyms so that the person to whom the data relates cannot be identified without the use of additional information which is meant to be kept separately and secure.
Patient service operations
PSSD
Patient specific visit source document.
Legal and Compliance
PVR partner
Another commercial enterprise or a natural person with whom PVR has strategic business relations.
Quality
Process step class
There shall be three process step classes:
· Regular
· Parallel
· Either/or
HR
Serious misconduct
A serious breach of rules, regulations, and/or duties may lead to a final written warning being issued irrespective of previous warnings given to the employee concerned. In the case where an employee had previous written warnings with no improvement or repetition of written warnings, this may lead to a final written warning. After a final written warning with continuous repetition, this may result in dismissal.
Quality
QMS document approval
The signatures of the developers listed in section "Document developers" also indicate the approval of the QMS document.
Quality
QMS document development
A continuous and cyclical process whereby:
· New QMS documents are initiated, created, reviewed, and approved.
· Existing QMS documents are maintained: reviewed, updated, revised, and approved.
Quality
QMS registry
A computerized system for storing, cataloging, and accessing the QMS documents.
Patient service operations
Qualified person
The licensed pharmacist, responsible for ensuring the quality of medicines, compliance with pharmaceutical regulations (GxP Compliance) in manufacturing, wholesale, import and export.
Clinical operations
Qualified translator
The company employee who is considered to have sufficient ability in one or more languages other than their native language to perform translations. They shall be familiar with medical and clinical trial terminology.
Patient service operations
Quality agreement
Is a comprehensive document that outlines both specific quality parameters for services and which party is responsible for the execution of those parameters.
Quality
Quality management system
Policies and procedures which include process flows with a clear allocation of responsibilities.
A quality management system is:
· Detailed in a set of formal documents.
· Designed to enable the achievement of the quality policy and objectives.
Quality
Quality reviewer
An employee of the quality division authorized by the head of quality to act as reviewer. One quality reviewer shall always be assigned.
Clinical operations
Randomization
The process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments to reduce bias.
Finance
Responsible for budget
A member of an organization who is in charge of the financial decisions within their respective area of responsibility. This person is responsible for making sure that the budget plan is followed and ensures that everyone adheres to the rules set forth.
Clinical operations
Regulatory authorities (RA)
Bodies which have the power to regulate. In the ICH GCP guideline the expression Regulatory authorities includes the authorities that review submitted clinical data and those that conduct inspections.
Legal and Compliance
Related policies
Replacing information that directly or indirectly identifies an individual with one or more artificial identifiers or pseudonyms so that the person to whom the data relates cannot be identified without the use of additional information which is meant to be kept separately and secure.
Technology
Remote access
The ability to connect to PVR resources or networks from outside the corporate premises.
Quality
Remote audit
An e-audit that uses electronic means to remotely obtain audit evidence and evaluate it objectively in order to determine the extent of conformity to the audit criteria.
Marketing
Research plan
A plan outlining the approach, methodology, and objectives of a market research project to guide the study and provide useful insights into the target market.
Quality
Resource document
A document which is referenced in a PVR QMS document.
Quality
Reviewer
An employee who actively participates in writing the QMS document, by providing feedback and suggesting improvements and corrections. A reviewer shall be assigned by the process owner in collaboration with the author. At least one reviewer shall be assigned.
Quality
Role
A prescribed or expected behavior associated with a particular position.
Clinical operations
Serious adverse event (SAE)
Any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization and results in persistent or significant disability/incapacity.
Clinical operations
Serious breach (in clinical trials)
A breach of the protocol or the conditions and principles of GCP is defined as serious if it significantly affects the safety, physical or mental integrity of the clinical trial subjects or the scientific validity of the trial.
Patient service operations
Service components
A distinguishable and identifiable part of the service.
Patient service operations
Service registry
A registry that displays list of all services performed by PVR.
Quality
Significant change
A change that considers a high probability to impact the quality and/or safety.
Marketing
SMART
A goal-setting technique that helps to create specific, measurable, achievable, relevant, and time-bound goals.
Clinical operations
Source data
All information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Source data are contained in source documents (original records or certified copies).
Clinical operations
Source documents
Original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, subjects' diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions certified after verification as being accurate copies, microfiches, photographic negatives, microfilm or magnetic media, x-rays, subject files, and records kept at the pharmacy, at the laboratories and medico-technical departments involved in the clinical trial).
Legal and Compliance
Special categories of personal data
Information revealing racial or ethnic origin, political opinions, religious or similar beliefs, trade union membership, physical or mental health conditions, sexual life, sexual orientation, biometric or genetic data.
Clinical operations
Sponsor
An individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial.
Quality
Standard operating procedure (SOP)
A standard operating procedure shall include a section describing the framework, standards, principles, or guidelines for PVR's procedures. It shall also include a process flow section. Depending on the on the purpose of the standard operating procedure, only section 3 or 5 maybe completed or both sections 3 and 5. Standard operating procedures shall be created in Word/Excel, landscape. Excel only to be used if necessary. (PVR)Detailed, written instructions to achieve uniformity of the performance of a specific function (ICH GCP Guidelines).
Clinical operations
Standard Operating Procedures (SOPs)
Detailed, written instructions to achieve uniformity in the performance of a specific function.
Patient service operations
Statement of work (SoW)
An agreement between parties that has specification on services, costs, and timelines.
Clinical operations
Sub-investigator
Any individual member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions (e.g., associates, residents, research fellows).
Clinical operations
Subject card
A card given to the subject after randomisation to keep with them incase of an emergency to hand over to medical personnel. This card shall contain the study number and an emergency contact number.
Clinical operations
Subject/trial subject/participant
An individual who participates in a clinical trial, either as a recipient of the investigational product(s) or as a control.
Quality
Subordinate document
An internal resource document (document 1) which is referenced in another PVR QMS document (document 2) and whose exclusive purpose is to support performing the process described in document 2.
Finance
Supporting documents
Any documentation which can support a request/claim e.g. receipts, tickets, accommodation invoice and confirm the expenses
Marketing
System owner
Any employee who is responsible for the availability, maintenance, and proper functioning of the software.
Clinical operations
TMF
Trial master file
Patient service operations
Tender process
Tendering is the process by which an organization who is in need of goods / services invites other parties to submit a proposal or bid to provide these goods / services. This invitation is formally referred to as a Request for Tender.
Quality
Template (TMPLT)
A business A pre-formatted file type that can be used to develop policies, standard operating procedures, protocols, forms, guidelines, and work instructions. Templates are available in Word and Excel format for use.area in PVR which is directly below a division in the hierarchy, and whose function is substantial enough to qualify as a unit in its own.
Legal and Compliance
UK GDPR
The retained EU law version of the General Data Protection Regulation ((EU) 2016/679) as defined in the Data Protection Act 2018. personal data is subject to the legal safeguards specified in the UK GDPR.
Quality
Unit
A business area in PVR which is directly below a division in the hierarchy, and whose function is substantial enough to qualify as a unit in its own.
Patient service operations
USDA
United States Department of Agriculture. USDA approval for import of biosamples to USA shall be provided by client/sponsor/consignee. In case USDA approval is not required, client/sponsor/cpnsignee shall provide with letter that USDA approval is not require for import because biosamples are of human origin and for medical diagnostics only.
Patient service operations
Vendor
Any person or company that is contracted by PVR to provide services or perform activities which are not a role as defined in SOP-EXEC-001 "Organizational structure and culture".
Patient service operations
Vendor coordinator
Company employee responsible for vendor management appointed by head of patient service operations.
Patient service operations
Vendor evaluation group
Include legal employee, finance employee, quality employee, vendor coordinator.
Patient service operations
Vendor evaluation form
Is a form that lists evaluation criteria of possible vendor.
Patient service operations
Vendor management
Structured process that allows to manage PVR's vendors to ensure the goods and services are delivered on time with high quality and meet business objectives at the best value.
Patient service operations
Vendor matrix
Is a grid-style tool used during vendor evaluation process that lists vendors classification/categorization and obligatory documents requirements depending on the vendor type.
Patient service operations
Vendor re-evaluation form
Is a form that list re-evaluation criteria of existing vendor.
Patient service operations
Vendor registry
Is a form that list re-evaluation criteria of existing vendor.
Patient service operations
Vendor performance form
Is a form that used during vendor performance management process that lists criteria of performance evaluation and necessary actions based of result.
Patient service operations
Vendor/tender committee
Head of relevant divisions or appointed employees who take part in tendering process.
Patient service operations
Vendor tendering form
Is a form that used during vendor tendering process that lists evaluation criteria to select the best vendor for company.
Patient service operations
Vendor request
A request from the patient service coordinator to a vendor to deliver specific a service.
Quality
Work instruction (WI)
If a specific standard operating procedure, a process step represents an elaborate process, and if this step is only applicable to this standard operating procedure, then a work instruction shall be written in purpose of describing this specific step. The work instruction shall always include a process flow, section 5, (section 3 might be not applicable) and it shall always be subordinate to the standard operating procedure. Work instructions shall be created in Word/Excel, landscape. Excel only to be used if necessary.
