leeds teaching hospitals nhs trust - appendices ... · web view2016/12/13 · final. 13.12.2016 2...

Induction Resource forClinical Research

Delivery Staff

Appendices - Printable Resources

All printed copies of this Document are considered 'Uncontrolled Copies'. Printed copies are only valid for the day printed

Induction resource Version 1.0. FINAL. 13.12.2016 1

Appendix I - Induction checklist

Form to be completed by you and your manager.Training/activity Required Date of

trainingEmployee Signature

Managers Signature

Yes NoGood Clinical Practice (GCP) training

Human Tissue Act training

Read Trust Research Governance Policy

Handling and packaging samples for transport (COSHH)

Medical devices training

EDGE training

Informed Consent training

Attend a Clinical Research Forum meeting

Establish a research buddy

Induction registration form completed and returned

Stock ordering training

Completed and returned induction resource feedback form

Electronic database training e.g. PPM/PAS

This list is not exhaustive and there may be other training relevant to your area.PRINTABLE PAGE FOR TRAINING FILE



Appendix II - Induction Resource Registration Form

Name

Job title and band

Area of work/speciality

Managers name and contact details

Contact phone number

Work email address

Start date

Please complete, and return this form during the first week of your employment in your new

post. You will receive notification of receipt as evidence of completion for your induction.

Please return to Research and Innovation via email to [email protected]

http://www.leedsth.nhs.uk/research

Good luck in your new role!



Appendix III- Research CV Template

SUBMISSION OF CURRICULUM VITAE (CV) TO RESEARCH ETHICS COMMITTEES AND NHS R&I OFFICES

Guidance for applicants Your CV needs to demonstrate that you are qualified by education, training and experience to conduct the research. A standard template for an Investigator CV is set out below. This template would be suitable for submission of CVs by: • Chief Investigators (for submission with main REC application) • Local Principal Investigators (for submission with the Site-Specific Information Form to RECs and NHS R&I offices) • Academic supervisors (for submission with student applications).

The template is issued as guidance and is not intended to be prescriptive. Use of the template is not a requirement for a valid application. The National Research Ethics Service (NRES) Standard Operating Procedures state that CVs should be a maximum of 2 pages. This is also guidance and is not an absolute requirement. It is important that experience relevant to the specific research project is fully summarised, but the overall document should be kept concise. It is not necessary to provide a complete record of the applicant’s professional and academic background. In particular, CVs should not include lengthy lists of publications. This template is recommended by NRES and the NHS R&I Forum for applications both for ethical review and R&I approval



Research CVName:

Present appointment: (Job title, department, organisation)

Address: (Full work address)

Telephone number: Email address:

Qualifications:

Professional registration: (Name of body, registration number and date of registration)

Previous and other appointments: (include previous appointments in the last 5 years and other current appointments)

Research experience: (Summary of research experience, including the extent of your involvement. Refer to any specific clinical or research experience relevant to the current application)

Research training: (Details of any relevant training or conduct of research, for example in the Clinical Trials Regulations, Good Clinical Practice, consent or other training appropriate to non-clinical research. Give the date of the training)

Relevant publications: (Give reference to all publications in the last two years plus other publications relevant to the current application)

Signature: Date:



Appendix IV - Example Training File NIHR Leeds CRF Training File

NIHR Leeds Clinical Research Facility

Training File

Name:

Job Title:

Start Date:

Leave Date

Confidential: UNAUTHORISED COPYING PROHIBITED of 21

Quality Assurance Department, NIHR Leeds Clinical Research Facility, St James Institute of Oncology, Level 6 Bexley Wing, Beckett Street, Leeds, LS9 7TF, UK



1 Copy of job description

2 Signed and dated CV(Documented on the NRES CV template. Renewed annually, retain all versions)

3 Membership of professional associations (e.g. NMC, National or local cancer groups, RCN – include copy of official notification of membership/renewal)

4Records of all research specific training (Including GCP certificates)-If not certificated, retain schedule/agenda/hand-outs

5Records of all mandatory Trust specific training. (e.g. health and safety training)-If not certificated, retain schedule/agenda/hand-outs

6Records of all other continuing education –courses/seminars/training sessions.(Include induction programme)

7 Copies of Publications/Presentations

8 Copies of professional and higher educational certificates

9 Departmental SOP log

10 MiscellaneousConfidential: UNAUTHORISED COPYING PROHIBITED

Page 2 of 21



Appendix V - Research acronyms

Acronym DefinitionABPI Association of British Pharmaceutical IndustryACFs Academic Clinical FellowshipADE Adverse Device EffectAE Adverse EventAHC Applied Health Co-operativeAHPs Allied Health ProfessionalsAHSN Academic Health Science NetworkAMRC Association of Medical Research CharitiesAMS Academy of Medical SciencesARSAC Administration of Radioactive Substance Advisory

CommitteeBBSRC Biotechnology & Biological Sciences Research CouncilBIA Bio Industry AssociationBRCs Biomedical Research CentresBRUs Biomedical Research UnitsCATP Clinical Academic Training ProgrammeCCF Central Commissioning FacilityCCG Clinical Commissioning Groups (e.g. GPs)CDA Confidentiality AgreementCI Chief InvestigatorCLAHRC Collaborations for Leadership in Health Research CareCPMS Central Portfolio Management SystemCQC Care Quality CommissionCRA Collaborative Research AgreementCRA Clinical Research Associate (Monitor)CRD Centre of Reviews and DisseminationCRF Case Report FormCRFs Clinical Research Facilities for Experimental MedicineCRN Clinical Research NurseCRN Clinical Research NetworkCRO Clinical Research OrganisationCRUK Cancer Research UKCSP Coordinated System for gaining NHS PermissionCSR Comprehensive Spending ReviewCSU Clinical Support UnitCT Toolkit Clinical Trials Toolkit



CTA Clinical Trials AuthorisationCTA Clinical Trials AssistantCTC Common Toxicity CriteriaCTFs Clinical Trials FellowshipCTIMP Clinical Trials involving Medicinal ProductsCTRUs Clinical Trials Research UnitsCV Curriculum VitaeD4D Devices for DignityDARE Database of Abstracts of Reviews of EffectsDECs Diagnostic Evidence CooperativeDementia TRC Dementia Translational Research CollaborationDH Department of HealthDMC Data Monitoring CommitteeDRFs Doctoral Research FellowshipDSMB Data Safety and Monitoring BoardECMCs Experimental Cancer Medicine CentresEME Efficacy and Mechanism Evaluation ProgrammeEMEA European Medicines Evaluation AgencyEOI Expression Of InterestEORTC European Organisation for Research and Treatment of

CancerEPSRC Engineering & Physical Sciences Research CouncilESRC Economic & Social Research CouncilEudraCT European Drug Regulation Authorities in Clinical TrialsFDA Food and Drug Administration (US)FP Fellowships ProgrammeFT Foundation TrustGCP Good Clinical PracticeGLP Good Laboratory PracticeGMP Good Manufacturing PracticeHCAP Honorary Clinical Associate ProfessorHEE Health Education EnglandHEI Higher Education InstituteHICF Health Innovation Challenge FundHLO High Level Objectives (Clinical Research Network)HRA Health Research AuthorityHRA Health Research AuthorityHS&DR Health Services and Delivery Research ProgrammeHSC Horizon Scanning Centre



HSP Healthcare Scientists ProgrammeHSR Health Service ResearchHSRN Health Services Research NetworkHTA Health Technology Assessment ProgrammeHTCs Healthcare Technology Co-operativesHTMR Hubs for Trials Methodology Researchi4i Innovation for Innovation ProgrammeIAT Integrated Academic Training ProgrammeIB Investigator BrochureICF Informed Consent FormICH GCP International Conference on Harmonisation - Good

Clinical PracticeICR Institute of Clinical ResearchIMP Investigational Medicinal ProductINVOLVE INVOLVE Patient Involvement national advisory groupIP Intellectual PropertyIRAS Integrated Research Application SystemIRMER Ionising Radiation Medical Exposure RegulationsIS Information Systems ProgrammeISR Independent Scientific ReviewKMFs Knowledge Mobilisation FellowshipKPI Key Performance IndicatorKSF Knowledge and Skills FrameworkLMBRU Leeds Musculoskeletal Biomedical Research UnitLS&DP Leadership Support & Development ProgrammeLTHT Leeds Teaching Hospitals NHS TrustmCIA model Clinical Investigation AgreementmCTA model Clinical Trial AgreementMEDTECH Medical Technology CompaniesMHRA Medicines and Healthcare Products Regulatory

AgencyMoU Memorandum of UnderstandingMRC Medical Research CouncilMRC-NIHR NPC MRC-NIHR National Phenome CentreMRP Methodology Research ProgrammeNDA Non-Disclosure AgreementNETS CC NIHR Evaluation, Trials and Studies Coordinating

CentreNGO Non-Governmental Organisation



NHS National Health ServiceNHS E NHS EnglandNHS EED NHS Economic Evaluation DatabaseNICE National Institute for Health & Care ExcellenceNIHR National Institute for Health ResearchNIHR BRC NIHR Biomedical Research CentresNIHR BRU NIHR Research Biomedical Research UnitsNIHR CCF NIHR Central Commissioning FacilityNIHR DEC NIHR Diagnostic Evidence Co-operativeNIHR HTA NIHR Health Technology AssessmentNIHR PGfAR NIHR Programme Grants for Applied ResearchNIHR RDS NIHR Research Design ServiceNIHR RfPB NIHR Research for Patient BenefitNIHR TCC NIHR Trainees CoordinatingNOCRI NIHR Office for Clinical Research InfrastructureNRES National Research Ethics ServiceODP Open Data PlatformOGD Other Government DepartmentOSCHR Office for Strategic Co-ordination of Health ResearchPAS Patient Administration SystemPCPIE Patient, Carer & Public Involvement & EngagementPDAs Product Development AwardsPDGs Programme Development GrantsPHARMA Pharmaceutical companiesPHE Public Health EnglandPHR Public Health Research ProgrammePI Principal InvestigatorPID Performance in Initiation & DeliveryPIS Patient Information SheetPIS Patient Information SheetPPI Patient and Public InvolvementPPM Patient Pathway Management (system)PRA Patient Research AmbassadorsPROSPERO Database of Prospectively Registered Systematic

ReviewsPRP Policy Research Programme (DH)PSTRC Patient Safety Translational Research CentreQA Quality AssuranceR&D Research and Development



R&I Research & InnovationRCD Research Capacity DevelopmentRCF Research Capability FundingRCGP Royal College of General PractitionersRCN Royal College of NursingRCT Randomised Controlled TrialsRDS Research Design ServiceREC Research Ethics CommitteeREF Research Excellence FrameworkRET Research, Education and Training CommitteeRFPB Research For Patient Benefit ProgrammeRM&G Research Management and GovernanceRMP Research Methods ProgrammeRP Research PassportRSS Research Support ServiceRTT Recruitment to Time & TargetSAE Serious Adverse EventSAR Serious Adverse ReactionSLA Service Level AgreementSME Small, Medium EnterpriseSOP Standard Operating ProcedureSSA Site Specific AssessmentSTRF Science & Technologies Facilities Research CouncilSUSAR Suspected Unexpected Serious Adverse ReactionsTARs Technology Assessment ReviewsTCC Trainees Coordinating CentreTMF Trial Master FileTRFs Transitional Research FellowshipsTRPs Translational Research PartnershipTSF Trial Site FileUK CRGs UK Cochrane Review GroupsUK CTG UK Clinical Trials GatewayUKCC UK Cochrane CentreUKCRC UK Clinical Research CollaborationUKTI UK Trade and InvestmentUoL University of LeedsYH Yorkshire and Humber



Appendix VI - Glossary

Adverse Reactions Also known as side effects, adverse reactions include any undesired actions or effects of the experimental drug or treatment. Experimental treatments must be evaluated for both immediate and long-term side effects.

Arm Any of the treatment groups in a clinical trial. Most randomised trials have two “arms”, or even more.

Baseline Baseline information is gathered at the beginning of a study from which variations found in the study are measured. Baseline can also be described as a known value or quantity with which an unknown is compared when measured or assessed. Safety and efficacy of a drug are often determined by monitoring changes from the baseline values.

Bias When a point of view prevents impartial judgement on issues relating to the subject of that point of view. In clinical studies, bias is controlled by blinding and randomisation.

Blind, Blinded, or Blinding

A clinical trial is “blinded” if the participants are unaware on whether they are in the experimental or control arm of the study. Blinding may also be extended to the investigators so that their patient observations are less likely to be biased by their awareness of the treatment the patient is receiving.

Case Control Study A scientific study that compares a group of people with a disease to a similar group of people without that disease.

Chief Investigator Researcher in charge of carrying out a clinical trial protocolClinical Research Associate (CRA)

Person employed by the study sponsor or clinical research coordinator to monitor a clinical trial at one or more participating sites. The CRA is responsible for ensuring all clinical studies are conducted according to study protocol, within regulations and ICH guidelines.

Clinical Research Coordinator (CRC)

Site Administrator for the clinical trial who is responsible for coordinating administrative activities between field and home offices staff, such as the collection of essential documents, distribution of supplies and site selection. Also called research study or health care coordinator, data manager, research nurse or protocol nurse.

Clinical Research Organisation (CRO)

A commercial organisation contracted by a research and development organisation to perform one or more research related functions.

Clinical Trial A clinical trial is a research study designed to methodologically answer specific questions about novel therapies, treatment techniques or new ways of using known treatment. Clinical trials (also called medical research and research studies) are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people.

Clinical Trial Authorisation

The authorisation from the MHRA as Competent Authority, in the UK to conduct a clinical trial of an investigational medicinal product (CTIMP).

Clinical Trial of an Investigational Medicinal Product (CTIMP)

Is any investigation in human subjects, other than non-investigational trial, intended to a) discover or verify the clinical, pharmacological or other pharmacodynamics effects of one or more medicinal products; b) to identify any adverse reactions to one or more such products or c) to study absorption, distribution, metabolism and excretion of one or more such products with the object of ascertaining the safety or efficacy of those



products.Clinical Trial Regulations

The Medicines for Human Use (Clinical Trials) Regulations 2004

Cohort In epidemiology, a group of individuals with some characteristics in common.

Community-based Clinical Trial

A method of providing experimental therapeutics prior to final approval for use in humans, this procedure is used with very sick individuals who have no other treatment options. Often approval is on a case-by-case basis.

Complementary and Alternative Therapy

Broad range of healing philosophies, approaches, and therapies that Western (conventional) medicine does not commonly use to promote well-being or treat health conditions.

Confidentiality Regarding Trial Participants

Refers to maintaining the confidentiality of trial participants including their personal identity and all personal medical information. The trial participants consent to the use of their records for data verification purposes should be obtained prior to the trial and assurance must be given that confidentiality will be maintained.

Contraindication A specific circumstance when the use of certain treatments could be harmful.

Control Group The standard by which experimental observations are evaluated. In many clinical trials, one group of patients will be given an experimental drug or treatment, while the control group is given either a standard treatment for the illness or a placebo (See Placebo and Standard Treatment).

Controlled Trials A control is a standard against which experimental observations may be evaluated. In a controlled clinical trial, one group of participants is given an experimental drug, while another group (i.e. the control group) is given either a standard treatment for the disease or a placebo.

Crossover Trials A clinical trial in which all participants receive both treatments, but at different times. At a predetermined point in the study, one group is switched from the experimental treatment to the control treatment (standard treatment), and the other group is switched from the control to the experimental treatment.

Data Safety and Monitoring Board (DSMB)

An independent committee composed of community representatives and clinical research experts that review data while a clinical trial is in progress to ensure that participants are not exposed to undue risk. A DSMB may recommend that a trial be stopped if there are safety concerns or if the trial objectives have been achieved.

Demographic Data The characteristics of participant group or populations. This could include data on race, age, sex and medical history, all of which can be relevant to the clinical trial study findings.

Device An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or other similar or related article, including any component, part or accessory that is used to diagnose, cure, treat or prevent disease. A device does not achieve its intended purpose through chemical action or metabolism in the body.

Diagnostic Trials Refers to trials that are conducted to find better tests or procedures for diagnosing a particular disease or condition. Diagnostic trials usually include people who have signs or symptoms of the disease or illness being studied.

Dose-ranging Study A clinical trial in which two or more doses of an agent (such as a drug) are tested against each other to determine which dose works best and is least



harmful.Double-Blind Study A clinical trial design in which neither the participating individuals nor the

study staff knows which participants are receiving the experimental drug and which are receiving the placebo (or another therapy). Double-blind trials are thought to produce objective results, since the expectations of the doctor and the participants about the experimental drug do not affect the outcome (See Blind, Single-Blind Study and Placebo).

Drug-Drug Interaction A modification of the effect of a drug when administered with another drug, the effect may be an increase or a decrease in the action of either substance, or it may be an adverse effect that is not normally associated with either drug.

Efficacy The maximum ability of a drug or treatment to produce a result regardless of dosage. A drug passes efficacy trials if it is effective at the dose tested and against the illness for which it is prescribed.

Eligibility Criteria Summary criteria for participant selected; includes inclusion and exclusion criteria (See Inclusion and Exclusion Criteria).

Empirical Based on observation or experience, not experimental data.Endpoint Overall outcome that the protocol is designed to evaluate.Epidemiology The branch or medical science that deals with the study of incidence,

distribution and control of a disease in a population.Ethics Committee (or Institutional Review Board)

A committee of doctors, statisticians, researchers, community advocates and others that ensure that the rights of study participants are protected. Every institution that conducts or supports biomedical or behavioural research involving human participants must, by federal regulation have an ethics committee (IRB) that approves and periodically reviews the research in order to protect the rights of human participants.

EU Directive Directive 2001/20 EC of the European Parliament and the Council of the European Union relating to the implementation of good clinical practice in the conduct of the clinical trials of medicinal products for human use.

Expanded Access Refers to the distribution of experimental drugs to participants who are failing on currently available treatments for their condition and who are also unable to participate in on-going clinical trials.

Food and Drug Administration (FDA)

The US Department of Health and Human Services agency responsible for ensuring the safety and effectiveness of all drugs, biologics, vaccines and medical devices, including those used in the diagnosis, treatment and prevention of HIV infection, AIDS and AIDS-related opportunistic infections. The FDA also works with the blood banking industry to safeguard the US national blood supply.

Health Research Authority (HRA)

The HRA works closely with the MHRA and NIHR creating a unified approval process and to promote proportionate standards for compliance and inspection within a consistent national system of research governance

Hypothesis A supposition or assumption advanced as a basis for reasoning or argument, or as a guide to experimental investigation.

Inclusion/Exclusion Criteria

The medical or social standards determining whether a person may or may not be allowed to enter a clinical trial, these criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. It is important to note that inclusion and exclusion criteria are used to identify appropriate participants and keep them safe.



Informed Consent The process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the whole of the study to provide information to participants. To help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study.

Informed Consent Document

The process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the whole of the study to provide information to participants. To help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study.

Intent to Treat Analysis of clinical trial results that include all data from participants in the groups to which they were randomised even if they never received the treatment.

Interventions Primary experimental treatments being studied. Types of treatments may include drug, gene transfer, vaccine, behaviour, device or procedure.

Investigational Medicinal Product (IMP)

A pharmaceutical form of an active substance or placebo being tested, or to be tested, or used, or to be used, as a reference in a clinical trial and includes a medicinal product which has a marketing authorisation but is, for the purposes of the trial:a) Used to be assembled (formulated or packaged) in a different way from

the form of the product authorised under the authorisation;b) Used for an indication not included in the summary of product

characteristics under the authorisation for that product;c) Used to gain further information about the form of that product as

authorised under the authorisationInvestigator’s Brochure (IB)

A document containing a summary of the clinical and non-clinical data relating to an investigational medicinal product which are relevant to the study of the product in human subjects.

IN VITRO Testing or action outside an organism (e.g. inside a test tube or culture dish).

IN VIVO Testing or action inside an organism, such as a human subject or patient.Lead Site In the case of a multi-site study, the site for which the Chief Investigator is

also the Principal Investigator.Medicines and Healthcare products Regulatory Agency (MHRA)

Is the competent authority for the UK in relation to the EU Directive and the Clinical Trials Regulations. MHRA (Devices) is the competent authority for the UK in relation to the Medical Devices Regulations 2002.

Meta-Analysis Systematic methods that use statistical techniques for combining results from similar studies to obtain a quantitative estimate of the overall effect of a particular intervention or variable on a defined outcome. This type of analysis is typically hypothesis generating.

Multi-Centre Trial Clinical trial conducted according to a single protocol but at more than one site and therefore carried out by more than one investigator.

National Research Ethics Centre

Directorate within the National Patient Safety Agency that provides help and leadership for RECs by co-ordinating the development of operational and infrastructure arrangements in support of their work. This includes implementing standards to ensure national consistency, providing training for REC members and Co-ordinators, identifying IT solutions for procedural management and establishing regional REC centres to manage RECs.



Observational Study An epidemiological study that does not involve any intervention, experimental or otherwise. Such a study may be one in which nature is allowed to take its course, with changes in one characteristic being studied in relation to changes in other characteristics. Analytical epidemiologic methods such as case-control and cohort study designs are properly called observational epidemiology because the investigator is observing without intervention other than to record, classify, count and statistically analyse results.

Off-Label Use A drug prescribed for conditions other than those approved by a country’s regulatory agency.

Open Label Trial A clinical trial in which doctors and participants know which drug or treatment is being administrated.

Outcome Trial/Study An outcomes trial evaluates the effects of a treatment on patients. Treatments may include changes in disease status, morbidity or mortality.

P-Value A p-value demonstrates the likelihood that sample data do not adequately represent the population from which they were drawn. The accepted standard for a statistically significant p-value is <0.05 meaning that the likelihood that the result could occur by random chance is less than 5 in a hundred.

Parallel Study A parallel designed clinical trial compares the results of a treatment on two separate groups of patients. The sample size calculated for a parallel design can be used for any study where two groups are being compared.

Peer Review Review of a clinical trial by experts chosen by the study sponsors. These experts review the trial for scientific merit, participant safety and ethical considerations.

Pharmacology The study of how drugs interact with living organisms to produce a change in function. Pharmacology deals with how drugs interact within biological systems to affect function.

Pharmacokinetics The process of absorption, distribution, metabolism and excretion of a drug or vaccine.

Pharmacovigilance The science of collecting, monitoring ,researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications, biological products, herbalism and traditional medicines with a view to identify new information about hazards associated with medicines and preventing harm to patients.

Pivotal Study A study, usually phase three, which represents the data used by regulatory agencies to decide whether to approve a drug. A pivotal study will generally be well-controlled, randomised and whenever possible double- blind.

Placebo A placebo is an inactive pill, liquid, or powder that has no treatment value. In clinical trials, experimental treatments are often compared with placebos to assess the treatments effectiveness.

Placebo Controlled Study

A method of investigation of drugs in which an active substance is given to one group of patients, while the drug that is being tested is given to another group. The results obtained in the two groups are then compared to see if the investigational treatment is more effective in treating the condition.

Placebo Effect A physical or emotional change occurring after an inactive substance is taken or administered that is not the result of any special property of the substance. The change may be beneficial reflecting the expectations of



the participant and often the expectations of the person giving the substance.

Preclinical Trials Experiments performed in the laboratory and in animals to study a drug before it is tested in humans.

Prevention Trials Conducted to find better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vitamins, vaccines, minerals, or lifestyle changes.

Principal Investigator (PI)

The investigator responsible for the research site where the study involves specified procedures requiring site-specific assessment. There should be one PI for each research site. In the case of a single-site study, the CI and the PI will normally be the same person.

Prospective Study A prospective study identifies subjects, applies a treatment and follows them over time to measure their progress/outcomes relative to a predetermined set of criteria or endpoints.

Protocol A document that describes the objectives, design, methodology, statistical considerations (or other methods of data analysis) and organisation of a research study.

Quality of Life Trials Refers to trials that explore ways to improve comfort and quality of life for individual’s chronic illness.

Randomisation A method by which study participants are assigned to a treatment group. Randomisation minimises the differences among groups by equally distributing people among the trial arms.

Randomised Trial A study in which participants are randomly assigned to one of two or more treatment arms of a clinical trial.

Retrospective Study A study in which investigators select groups of patients that have already been treated and analyse data from the events experienced by these patients. These studies are subject to bias because investigators can select patient groups with known outcomes.

Risk –Benefit Ratio The risk a treatment places on individual participants versus the potential benefits of the treatment.

Screening Trials Refers to trials which test the best way to detect certain diseases or health conditions.

Serious Adverse Event (SAE)

Serious adverse event, an untoward occurrence that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity or consists of a congenital anomaly or birth defect.

Serious Adverse Reaction (SAR)

A serious adverse reaction in a CTIMP that results in death; is life-threatening; requires hospitalisation or prolongation of existing hospitalisation; results in persistent or significant disability or incapacity; or consists of a congenital anomaly or birth defect.



Side Effects Any undesired actions or effects of a drug or treatment. Experimental drugs must be evaluated for both immediate and long term side effects

Single Blind A study in which one party, either the investigator or participant is unaware of what medication the participant is taking.

Site Specific Assessment (SSA)

An assessment of the suitability of the investigator, site and facilities made for any study with a Principal Investigator at each research site.

Sponsor The person who takes on ultimate responsibility for the initiation, management and financing (or arranging the financing) of a clinical trial.

Standard Treatment A treatment currently approved, in wide use and considered to be effective in the treatment of a specific disease or condition.

Statistical Significance The probability that an event or difference occurred by chance alone. In clinical trials, the level of statistical significance depends on the number of participants studied and the observations made as well as the magnitude of the differences observed.

Study Endpoint An outcome used to judge the safety or effectiveness of a treatment.Surrogate Endpoint A biomarker or endpoint that is intended to substitute for a clinical

endpoint. A surrogate endpoint is expected to predict a clinical endpoint or lack thereof.

SuspectedUnexpected Serious Adverse Reaction (SUSAR)

A SUSAR is a CTIMP which is unexpected, meaning that its nature and severity are notconsistent with the information about the medicinal product in question set out:a) In the case of a product with a marketing authorisation, in the

summary of productcharacteristics for that product;b) In the case of any other investigational medicinal product, in the

investigator’s brochure relating to the trial in question.Toxicity A treatment related adverse effect that may be detrimental to the

recipient’s health. The level of toxicity associated with a treatment will vary depending on the attributes of the treatment itself and the condition the drug is being used to treat.



Appendix VII - Evaluation Form

Evaluation FormClinical Research Induction Resource

1. How long have you worked in Clinical Research?

Please tick

1 - 6 Months 6 - 12 Months 1 - 2 years

2 - 4 years 5 - 9 years 10 years +

2. What band are you?

Please tick

Band 2 Band 3 Band 4 Band 5

Band 6 Band 7 Band 8

3. Have you used a formal clinical research induction resource before?

Yes: No

If YES please list:___________________________________

4. What is your overall assessment of the usefulness of the clinical research induction resource?

(1 = insufficient - 5 = excellent) please circle below

1 2 3 4 5

5. Which topics/sections of the clinical research induction resource did you find most interesting or useful?



6. Has the clinical research induction resource helped you and your manager to successfully complete your induction to your new role?

Yes No If no, why?

7. Knowledge and information gained from using the clinical research induction resource?

Met your expectations: Yes No Somewhat

Will be useful /applicable in my work:

Definitely Mostly Somewhat Not at all

8. Do you have any comments or suggestions that would improve this research induction resource?

THANK YOU!

Please email this evaluation to:

[email protected] [email protected] [email protected]

This is an iterative document and links or advice may change. Please consult the R&I website or team for advice as appropriate in the first instance.



mailto:[email protected]



leeds teaching hospitals nhs trust - appendices ... · web view2016/12/13 · final. 13.12.2016 2...

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