ADR: Adverse Drug Reaction: Any noxious and unintended response.
AE: Adverse Event: Any unintended response.
ALC: Adults Lacking Capacity.
Amendment: A change made to the terms of a regulatory application, the protocol or any other supporting documentation.
Annual Safety Report: A report which must be submitted annually to the MHRA detailing SUSARs and SAEs which have occurred in the past year in studies involving an Investigational Medicinal Product.
Appointing Authority: The body responsible for the establishment and support of Research Ethics Committees (RECs) and Confidentiality Advisory Group.
APR: Annual Progress Report: A report to the Research Ethics Committee detailing recruitment and adverse event.
ARSAC: (Administration of Radioactive Substances Advisory Committee). Advises and issues licences to Health Departments to permit the use of specific radioactive medicinal products for diagnostic, therapeutic and research use.
Arm: A clinical trial can have one or more arms e.g. treatment arm and a placebo arm. The study participants are assigned to one arm.
Audit: A systematic and independent examination of study related activities and documentation to determine whether the study was conducted in accordance with the protocol, the sponsor’s Standard Operating Procedures, Good Clinical Practice (GCP) and the relevant regulatory requirements.
ASR: Annual Safety Report (see also DSUR)
BBSRC: Biotechnology and Biological Sciences Research Council.
BMA: British Medical Association.
BMJ: British Medical Journal.
Bodily Material: Human tissue which contains human cells. This excludes any material which has been rendered acellular.
BPI: Association of the British Pharmaceutical Industry: A trade association for pharmaceutical companies in the United Kingdom.
Blind: Occurs in randomised controlled trials. A trial is ‘Single-Blind’ if either the participants or the research team know which treatment arm the participants are receiving. ‘Double-Blind’ is where neither the participants nor the researchers know which treatment arm the participants are receiving.
CAG: The Confidentiality Advisory Group: Provides independent expert advice to the HRA (for research applications) and the Secretary of State for Health (for non-research applications) on whether applications to access patient information without consent should or should not be approved under the Health Service (Control of Patient Information) Regulations 2002.
CAG Specific Conditions of Support: Conditions from the Confidentiality Advisory Group to be met or accepted by the applicant before support can be given.
CAG Standard Conditions of Support: Conditions attached to all approved applications under the Health Service (Control of Patient Information) Regulations 2002.
Caldicott Guardian: A Caldicott Guardian is a senior person within an NHS organisation responsible for protecting the confidentiality of patient and service-user information and enabling appropriate information-sharing.
Care Organisation: The organisation(s) responsible for providing care to patients and/or users and carers participating in the study. Care organisations remain liable for the quality of care, and for their duty towards anyone who might be harmed by a study.
Care Team: The clinical care team refers to health professionals involved in the diagnosis, treatment or care of a patient. This includes pathology and radiology staff whose activities directly support the care of the patient even though usually they have no contact with the patient.
CAS: Central Allocation System.
CCGs: Clinical Commissioning Groups.
CE Mark: Conformité Européenne – European mark of approval for medical devices.
CF: Consent Form.
CHMP: Committee for Medicinal Products for Human Use.
CHM: Commission on Human Medicines.
CI: Chief Investigator, the investigator with overall responsibility for the research. In a multi-site study the CI has co-ordinating responsibility for research at all sites.
CIOMS: Council for International Organisations of Medical Sciences.
Clinical Audit: seeks to answer the question 'Does this service reach a pre-determined (published) standard?'
CTA: Clinical Trial Authorisation: The MHRA regulatory approval letter for clinical trials of investigational medicinal products.
CTA: Clinical Trial Assistant.
Clinical Trials Regulations: The Medicines for Human Use (Clinical Trials Regulations 2004).
Clock: The period allowed for the Research Ethics Committee's review of a new application or substantial amendment. The clock starts on receipt of a valid application. For new applications, the clock may stop once to request further information (provisional opinion) from the applicant. The period of the clock depends on the type of study. For substantial amendments, a 35 day clock applies in all cases and the clock does not stop.
Collaboration and Development Steering Group: A UK wide steering group that advises and supports the HRA to implement a unified approval process for research projects in the UK.
Competent Authority (CA): The regulatory body charged with monitoring compliance with the national statute and regulations of the European Member States.
Consent: For consent to be valid, it must be given voluntarily by an appropriately informed person who has the capacity to consent to the intervention in question. In specific circumstances the law does allow for a proxy to give consent (e.g. adults not able to consent for themselves and minors).
Control/Control Group: An alternative to the new treatment that is used as a comparator. A control can be a licensed treatment, a placebo or no treatment.
COREC: Central Office for Research Ethics Committees.
CQC: Care Quality Commission.
CRF: Case Report Form: A document (electronic or paper) designed to record all the protocol required information for each trial participant.
CRN: Clinical Research Nurse.
CRO: Contract Research Organisation: An organisation (commercial or academic) contracted to the sponsor to perform one or more of the sponsor’s trail-related duties.
Crossover Trial: A trail in which participants receive both the new treatment and the comparator, sequentially i.e. they receive one treatment for four weeks and then swap to the comparator treatment for four weeks; there is usually a wash out period between the two.
CSP: National Institute for Health Research (NIHR) Coordinated System for Gaining NHS Permission.
CT: Clinical Trial.
CTA: Clinical Trial Authorisation.
CTC: Clinical Trials Co-ordinator.
CTIMP: Clinical Trial of an Investigational Medicinal Product.
EAG: Expert Advisory Group.
ECC: Ethics and Confidentiality Committee, now administered by the CAG.
EFGCP: European Forum for Good Clinical Practice.
Electronic signature: A digitally encrypted signature capable of verification by an independent service provider, in accordance with the Electronic Signatures Regulations 2002.
Eligibility Criteria: The people who can (inclusion criteria) and cannot (exclusion criteria) participate in a trial.
Eligible Studies: Studies which receive external funding from a qualifying charity (one which subscribes to three qualifying standards: 1. strategic direction, 2. Open access, 3. Quality assurance) that are eligible for support from NHS Support for Science funding.
EMEA: European Medicines Agency: A European Union body organisation which has responsibility for the protection and promotion of public health through the evaluation and supervision of medicines for human use.
Employing organisation: An organisation employing the CI, other investigators and/or researchers. The Employer is liable for the work of its employees.
EPSRC: Engineering and Physical Sciences Research Council.
EU Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001: The laws, regulations for the conduct of clinical trials on medicinal products for human use in the European Members States.
EudraCT: The European Clinical Trials Database administered by the European Medicines Agency on behalf of the European Commission. It contains all medicinal and device trials which have commenced in the European Community since 1 May 2004.
EUTCD: European Tissues and Cells Directive.
EVCTM: The Eudravigilance Clinical Trials Module of EudraCT.
Excess Treatment Costs: The difference between the Treatment Costs incurred as a result of a particular research project and the costs which would have been incurred had the participants received standard care. By definition, Excess Treatment Costs only occur when experimental services are being provided or when standard care is being delivered in a different way to routine practice.
Full REC: Meeting at which usually non-Proportionate Review applications are reviewed (which have a 60 day time frame).
Funder: The Institution, Body or Individual(s) providing the funding for a study.
GAfREC: Governance Arrangements for NHS Research Ethics Committees.
GCP: Good Clinical Practice: An international ethics and scientific quality standard for deigning, conducting, recording and reporting trials which involve the participation of human subjects.
Generalisable Research Findings: The extent to which the findings of a clinical study can be reliably extrapolated from the subjects who participated in the study to a broader patient population and a broader range of clinical settings.
GMC: General Medical Council.
GMO: Genetically Modified Organism.
GMP: Good Manufacturing Practice: A quality assurance which ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authority or product specification. GMP relates to both production and quality control.
GPhC: General Pharmaceutical Council.
GTAC: Gene Therapy Advisory Committee.
HRA: Health Research Authority: Its aim is to simplify the process for approval of health research and will supersede CSP. For further information please contact R&D. HRA website: http://www.hra.nhs.uk/
HFEA: Human Fertilisation and Embryology Authority.
HFEA Research Register: Identifiable register of fertility treatments managed by the HFEA.
HSC: Health and Social Care Northern Ireland Gateway; it is the NHS Equivalent in Northern Ireland.
HSCIC: The Health and Social Care Information Centre is an Executive Non Departmental Public Body and has responsibility under the Health and Social Care Act 2012 for the collection, linkage, secure storage and publication of data from across health and social care. The HSCIC has responsibility for developing a Code of Practice for the use of confidential information for those processing confidential patient information.
HSE: Health & Safety Executive.
HTA: Human Tissue Authority.
IB: Investigator's Brochure, a document containing a summary of the clinical and non-clinical data relating to an investigational medicinal product (IMP) which are relevant to the study of the product in human subjects.
ICH-GCP: International Conference for Harmonisation: A collaboration between regulators and the pharmaceutical industry in Europe, the United States and Japan to establish common standards for clinical trials. ICH GCP is a widely recognised standard for Good Clinical Practice in clinical trials; its aim is to give assurance that the reported results are accurate, credible and that the rights, integrity and confidentiality of all participants have been protected throughout the study.
ICO: The Information Commissioners Office is the UK’s independent public body set up to uphold information rights in the public interest, promoting openness by public bodies and data privacy for individuals.
IGTK: The information Governance Toolkit is a performance tool produced by the Department of Health (DH) and hosted by the Health and Social Care Information Centre (HSCIC).
IMP: Investigational Medicinal Product: A pharmaceutical form of an active substance or placebo being tested or used as a reference in a CTIMP. This includes products which have a marketing authorisation when: 1. Formulated or packaged differently to the authorised form; 2. Used for an unauthorised indication; 3. Used to obtain further information about the authorised form.
IMPD: Investigational Material Product Dosier.
Information/Data custodian: The named individual, in an application to the Confidentiality Advisory Group (CAG), who is responsible for the security arrangements for the confidential patient information requested.
Indemnity: Compensation for damage, loss or injury.
Intellectual Property (IP): The novel or previously undescribed tangible output of any intellectual activity. It has an owner, can be sold, bought or licensed. IP can include inventions, industrial processes, software, data, written material, designs and images.
Intrusive Procedures: Can be defined for England and Wales (there is no Scottish or Irish equivalent) – ‘Intrusive’ research in England and Wales involving adults who lack mental capacity to consent falls under the Mental Capacity Act, which contains specific requirements for the conduct of such research. Intrusive research in this context is described as that where: “if a person taking part had capacity, the researcher would need to get consent to involve them”.
Invasive Procedure: In a research study this can be the insertion of a device, administration of the investigational medicine, administration of a questionnaire.
Investigator File: A compilation of the study’s site essential documents including regulatory documentation.
Ionising Radiation: The following procedures involve ionising radiation: X-rays, CT scans, DXA scans, radiotherapy (including brachytherapy and therapy using unsealed sources), radionuclide imaging (including diagnostic imaging and in vitro measurements). Please note that Magnetic Resonance Imaging (MRI) or ultrasounds do not involve ionising radiation.
IPEM: Institute of Physics and Engineering in Medicine (previously known as the Institute of Physics and Dental Medicine).
IRAS: Integrated Research Application System, the online single application system used to apply for most permissions and approvals required for research in health and social care/community care in the UK
IRAS Project Number: Single common reference to be used by all partners involved in the IRAS application.
IRB: Institutional Review Boards, please see OHRP.
ISO 9001: Internationally Recognised Standard for Quality Management Systems in the UK.
IVRS/IWRS: Interactive Voice/Web Response System.
KTN: Knowledge Transfer Network.
LAS: Local Allocation System, a telephone booking system for applications to a group of Research Ethics Committees supported from a single administrative centre/region.
Lead Site: The site where the Chief Investigator for a multi-centre study is based.
Local Collaborator: Some types of research which do not require a local investigator will nominate a Local Collaborator instead.
Marketing Authorisation: The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for granting marketing authorisations to medicines which meet the standards of safety, quality and efficacy. A marketing authorisation is required before a medicines can be prescribed or sold.
MCA: Mental Capacity Act 2005.
Medical Device: Any instrument, apparatus, appliance material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used on human beings for the purpose of •diagnosis, prevention, monitoring, treatment or alleviation of disease. Its principal mode of action is not pharmacological, immunological nor metabolic.
Meta-analysis: A review of the results of a large number of trials on a similar subject.
MHRA: Medicines and Healthcare products Regulatory Agency. The UK government agency responsible for ensuring that medicines and medical devices are acceptable and safe. It is the competent authority for CTIMPs and medical device trials.
MIA: Manufacturers Authorisation.
Minor amendment: An amendment which is not a substantial amendment; it does not require Research Ethics Committee (REC) review.
MODREC: Ministry of Defence Research Ethics Committee: Research Ethics Committee (REC) established by the Ministry of Defence to review research involving the British Armed Forces. MODREC has recognition from the United Kingdom Ethics Committee Authority (UKECA) to review Phase 1 clinical trials in healthy volunteers.
Monitoring: The process of over-seeing a research study to ensure that is conducted, recorded and reported in accordance with the protocol, standard operating procedures (SOPs), Good Clinical Practice (GCP) and the appropriate regulatory requirements.
MoU: Memorandum of Understanding.
MRC: Medical Research Council.
Multi-Centre Study/Trial: A study conducted at more than one site but with one protocol.
NHS: National Health Service.
NIBSC: National Institute for Biological Standards and Control.
NICE: National Institute of Clinical Excellence.
NIGB: National Information Governance Board for Health and Social Care. The NIGB was abolished at the end of March 2013 when responsibilities were transferred to Confidentiality Advisory Group (CAG).
NIHR: National Institute for Health Research.
NIMP: Non-Investigational Medicinal Product.
NISCHR: National Institute for Social Care and Health Research.
NISCHR PCU: National Institute for Social Care and Health Research Permission Coördinating Unit. It coördinates NHS permission in Wales.
No Opinion of a Research Study: A proportionate review application which has been referred to a full REC meeting for further review after being reviewed at a proportionate review meeting.
NOMS: National Offender Management Service; the Ministry of Justice high-level policy arm for prison and probation services in England and Wales, which reviews certain applications for research in the prison and probation service.
Non-CTIMP: Any research study that is not a clinical trial of an investigational medicinal product.
Notice of No Objection: Medicines and Healthcare products Regulatory Agency (MHRA) approval letter for CTIMPs and Device trials.
NPSA: National Patient Safety Agency; now abolished.
NRES: National Research Ethics Service; now part of the HRA.
NRS: NHS Research Scotland. NHS permission system for multicentre research in Scotland.
Observational Study: A study where the researcher is observing behaviours or outcomes. No attempt is made to affect the outcome e.g. no experimental treatment is administered.
OHRN: Offender Health Research Network (formerly known as Prison Health Research).
OHRP: Office for Human Research Protections, a unit within the US DHHS responsible for implementing Federal Regulations relating to research funded by the DHHS or its agencies. This includes registration of Independent Ethics Committees / Institutional Review Boards and the Federal Wide Assurance (FWA) scheme for organisations hosting research.
PALS: Patient Advice and Liaison Service.
Participant: Patient, service user, carer, relative of the deceased, professional carer, other employee, or member of the public, who consents to take part in a study. Under the Clinical Trials Regulations, participants in Clinical trial of an investigational medicinal product (CTIMP) are referred to as “subjects”.
Pharmacovigilance: The pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects of medicines.
Phase 1 Trial: The initial introduction of an investigational new drug into Humans. Phase 1 studies are closely monitored and may be conducted in patients or healthy volunteers.
Phase 2 Trial: Controlled clinical studies conducted to evaluate the effectiveness and to identify the short-term side-effects of a drug for a particular indication or indications in patients with the disease or the condition being studied. They are conducted in a relatively small number of subjects usually no more than several hundred.
Phase 2a Trial: A controlled clinical study that occurs after the completion of Phase 1 and Phase 2 studies and before Phase 3 studies.
Phase 3 Trial: Controlled and uncontrolled trials which are conducted after evidence from the earlier phases have been obtained suggesting that the drug is efficacious. The purpose of Phase 3 trials is to obtain additional further information about the efficacy and safety which is required to evaluate the overall benefit-risk ratio of the drug/intervention.
Phase 3B Trial: A subcategory of a phase 3 trial, conducted to elicit further findings and safety data: may be required for marketing approval.
Phase 4 Trial: Post marketing studies, requested by the marketing authorities, to obtain additional information about the drug's benefits, risks and optimal use which might be the regulatory authorities might request for marketing approval.
Phase 5 Trial: Sometimes called Post Marketing Surveillance. A phase 5 trial is concerned with financial costs, healthcare resource usage, and quality of life.
PI: Principal Investigator: The researcher who takes local responsibility for the conduct of a research study at his/her own site.
PIAG: Public Health England, and executive agency of the Department of Health.
PIS: Patient Information Sheet.
Placebo: A 'dummy' medicine that resembles the study medicine in appearance but has no physical effect on the participant. A study drug is often compared with a placebo as a means of obtaining more reliable efficacy data.
Protocol: A document that describes the objectives, design, methodology, data analysis and organisation of a research study.
Prospective Study: A study in which a group of participants is identified and then studies from that point forward in time. The opposite is a retrospective study.
Provisional opinion: A decision reached by a Research Ethics Committee (REC) on an application, subject to the receipt of further information or clarification from the applicant. The 60 day (for non-PRS application) or 14 day (for a proportionate review application) clock is suspended until the information is received.
Provisional opinion pending consultation with a referee: A written request for further information (provisional opinion) may be made following receipt of advice from a referee post full Research Ethics Committee meeting.
PRS: Proportionate review service for Research Ethics Committee applications.
PTF: Pharmacy Trial File.
QA: Quality Assurance: The planned and systematic actions that are established to ensure that the trial is conducted in its entirety in accordance with the applicable regulatory requirements.
QC: Quality Control: The operational activities which are conducted within the quality assurance to verify the requirements for quality of the research related activities.
QP: Qualified Person: The QP is the quality assurance professional for medicines defined by British law, based upon European Union directives. The QP ensures that every batch released to the market complies with its specification and has been made according to good manufacturing practice. Medicines from outside the EU also often have to be analysed and assessed as suitable for use by EU patients.
R&D: Research & Development.
RCT: Randomised Controlled Trial: The study participants are randomly allocated to receive (or not receive) a particular intervention (this could be two different treatments or one treatment and a placebo). Randomised controlled trials can avoid bias, if large enough, and meet criteria for statistical tests – other design options may not.
REC: Research Ethics Committee: An organisation that checks that ensures that research projects are ethical.
REC Reference Number: Reference number assiged by the REC accepting the application for review. This includes a REC local identifier, specific project number and year.
Receiving REC: The Research Ethics Committee (REC) that first receives an application, whether or not it is then transferred to another REC for review.
Recognised REC: A Research Ethics Committee (REC) legally recognised by United Kingdom Ethics Committee Authority (UKECA) to give an opinion on the ethical implications of a Clinical trial of an investigational medicinal product (CTIMP) to be undertaken anywhere in the UK.
RED: The Research Ethics Database, used by the REC system.
Regulatory Authorities: Organisations which ensure research is conducted in accordance with legal requirements e.g. Human Tissue Authority, MHRA.
Relevant Material: Defined by the HT Act as material other than gametes, which consists of, or includes, human cells. In the HT Act, references to relevant material from a human body do not include: (a) embryos outside the human body, or (b) hair and nail from the body of a living person.
Research Governance: A generic term to encompass the Research Framework standards and principles including all the relevant regulatory requirements.
Research Site: The organisation or unit responsible for conducting any of the research procedures in a study at a particular locality.
Resubmission: The submission of a previously unsupported application to Confidentiality Advisory Group (CAG) which includes amendments or further evidence to address those issues raised by the initial CAG review.
Retrospective Study: Research in which a group of participants is identified and then studied from that point backwards in time usually from medical notes and interviews. The opposite is a prospective study.
Revision of a Research Application: Any changes made to the terms of an application at the request of the REC following the meeting or, following issue of an opinion, before the research has started. Revision is not permitted prior to the REC meeting once the application has been validated.
RGPAS: Research Governance Project Approval System: A Papworth Hospital NHS Foudnation Trust committee which reviews all research studies which ae seeking Trust approval.
RMEG: Regenerative Medicine Expert Group (this group is supported by Department of Health in England).
RMG: Risk Management Group.
RNN: Risk Rating Number: a number indicating the relative risks of a study to the Participants, the Trust and the Study.
SACGM (CU): Scientific Advisory Committee on Genetically Modified Organisms (Contained Use) (Committee within the HSE).
SAE: Serious Adverse Event: An untoward occurrence that results in an unplanned hospitalisation, prolongation of hospitalisation, persistent or significant disability, a congenital abnormality, death or incapacity consists of a congenital anomaly or birth defect.
SAP: Statistical Analysis Plan.
SCIE: Social Care Institute for Excellence, which is the appointing authority for the Social Care Research Ethics Committee.
Scientific Officers: Staff appointed by the Health Boards in Scotland to provide expert advice to Research Ethics Committee (REC) and Research & Development (R&D) offices on the review of research proposals and manage REC centres.
SCREC: Social Care Research Ethics Committee (REC), the national REC for research in social care. The appointing authority for SCREC is the Social Care Institute for Excellence (SCIE).
SDBD: Scientific Development Bioethics Division (of Department of Health)
Second REC: The Research Ethics Committee (REC) that reiews an application on appeal following the issue of an unfavourable opinion by the 'first REC'.
Section 251 of the NHS Act 2006: The section of the NHS Act which enables the Secretary of State for Health to lay regulations capable of setting aside the common law duty of confidence for specified medical purposes
Service Evaluation: Service Evaluation: Seeks to the question 'What standard does this service achieve?'
Single Blind: see 'Blind'
Site-Specific Assessor: The body responsible for undertaking a site-specific assessment, either the and R&D office for a NHS site or an appropriate REC for a non-NHS site.
SmPC: Summary of Manufacturers Product Characteristics.
SOPs: Standard Operating Procedures.
Source Documents: Original documents, data and records e.g. medical records, laboratory results, participants’’ diaries, recorded data from automated instruments.
Sponsor: The person or an organisation who has the legal responsibility for the conduct of a clinical trial.
SSAR: Suspected Serious Adverse Reaction.
SSA: Site-specific assessment: An assessment performed to advise the main REC of the suitability of a site, facilities and research staff. An SSA must be completed for each site with a principal investigator.
SSIF: Site Specific Information form: Section of the IRAS which contains questions specific to an individual research site.
Standard Operating Procedure (SOP): Detailed, written instructions to achieve uniformity of the performance of a specific activity/function.
SUSAR: Suspected, Unexpected Serious Adverse Reaction: All suspected adverse reactions adverse reactions which are both unexpected and serious.
TA: Technical Agreement.
TMF: Trial Master File: A composite file held by the sponsor containing all regulatory and key documents for a study.
TOPs: The Over-volunteering Prevention System is a database, free to all UK organisations undertaking phase 1 trials in healthy volunteers, that aims to prevent participants from taking part too often in trials of new medicines. TOPS was run by an independent charity, but in April 2013, its function has come within the remit of HRA.
Transfer of a Research Ethics Application: The transfer of an application by the receiving Research Ethics Committee (REC) to another REC for review.
TSB: Technology Strategy Board.
TSC: Trial Steering Committee.
UKCRC: United Kingdom Clinical Research Collaboration: The UKCRC is a partnership of organisations working to establish the UK as a leader in clinical research in collaboration with the NHS.
UKCRN: UK Clinical Research Network.
UKECA: United Kingdom Ethics Committee Authority.
UKRMP: UK Regenerative Medicine Platform.
UKTI: UK Trade & Investment.
Unexpected Adverse Drug Reaction: AN adverse reaction whose nature, severity, specificity or outcome is inconsistent with the expected adverse reactions detailed in the relevant product information e.g. the Manufacturer’s Summary of Product Characteristics.
Unfavourable Opinion of a Research Ethics Application: An application cannot be approved in its current form, it can be revised and must be submitted as a new application.
Validation of an application to a Research Ethics Committee: An administrative check carried out by a Research Ethics Committee (REC) co-ordinator or Confidentiality Advisory team to verify that an application is complete and may be accepted for review. Decisions on validation should be made within five working days of receipt.
Validation date of an Application to the Research Ethics Committee: This is the date on which a valid application is received by a Research Ethics Committee (REC)/Confidentiality Advisory Group (CAG). It is the working day on which the complete application, including all relevant signatures and all supporting documents, are delivered to the REC/CAG office, either in electronic or paper format. This applies whether or not the co-ordinator or another member of the staff is present to receive the application. If at the point at which the application is booked the applicant refuses the next available meeting, the validation date will be the cut-off date of the REC meeting.
Vulnerable Subjects: Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of expected retaliatory response from senior members of a hierarchy in case of refusal to participate. Other vulnerable subjects include patients with incurable diseases, patients in emergency situations, persons in nursing homes, unemployed or impoverished situations, ethnic minority groups, homeless persons, itinerant persons, refugees, minors and those incapable of giving consent.
Xenotransplantation: The transplantation of live cells, tissues and organs from a non-human animal source into a Human Being.