The Institute of Clinical Research Disclaimer:
|
|
- Joseph Shelton
- 8 years ago
- Views:
Transcription
1
2 To be internationally recognised as the premier organisation for clinical research respected as a key influencer, promoting knowledge and understanding by engaging the healthcare community and the general public. The Institute of Clinical Research Thames House, Mere Park, Dedmere Road, Marlow, Buckinghamshire SL7 1PB info@instituteofclinicalresearch.org Telephone: Facsimile: Disclaimer: The opinions expressed in this publication are those of the subcommittee, and not necessarily those of The Institute of Clinical Research All rights reserved. No parts of this book may be reproduced by any means or transmitted, or translated into machine language without written permission of the publisher. ISBN Designed by Stretton Graphics To be a CRA 2
3 The leading organisation for clinical research professionals Internationally recognised as the premier organisation for clinical research, respected as a key influencer, promoting knowledge and understanding by engaging the healthcare community and the general public. Raising standards The Institute s professional standards encourage our members to work to the highest standards, enhancing the standards of clinical research and maintaining the professional identity of members The Institute recognises the academic achievement and clinical research experience by awarding designatory letters e.g. MICR to our members. Sharing knowledge The Institute offers a comprehensive range of Information Services and publications, including our journal Clinical Research focus, our publications, online resources, a resource centre and membership helpline. Developing professionals The Institute provides educational courses and training workshops, continuing professional development, academic qualifications and accreditation of training courses. All of these enhance the professional competence of our members. For more information call or visit raising standards sharing knowledge developing professionals
4 Acknowledgement Grateful thanks are extended to members of the CRA Subcommittee past and present for their input. Is this you or could this be you? Are you: Logical, Methodical and Organised? Approachable, friendly whilst being firm? Do you: Enjoy meeting new people? Enjoy travelling? Working both as part of a team, and independently? If so, then read on as a career in clinical research as a Clinical Research Associate (CRA) could be for you! To be a CRA 4
5 Contents Acknowledgement Is this you or could this be you? Contents Introduction The Clinical Research Associate (CRA) Definition Role and Functions Table Education and Training Opportunities Qualifications, Experience and Skills Qualifications: Experience: Essential Skills of a CRA include: Career Development CRA Level I: CRA Level II: CRA Level III or Senior CRA: How do I find a CRA Position? To be a CRA 5
6 The Institute of Clinical Research CRA Subcommittee Would you like to find out more? Drug Research and Development Phases of Clinical Research Organising a Clinical Trial Conclusions Organisations and Websites References Glossary To be a CRA 6
7 Introduction An important objective of clinical research is to ensure that marketed drugs are as safe and effective as possible. When a promising drug is discovered, a pharmaceutical company will plan a clinical development programme involving several phases of clinical research. Each phase will involve at least one clinical trial or trial, sponsored by the pharmaceutical company responsible for the drug to be tested. CRAs are involved in all phases of clinical research and at all stages of a particular trial. Therefore, possible CRA duties include most of the activities required to set up, monitor and complete a clinical trial. A new CRA is most likely to be involved in the initiation, monitoring and close-out of a selected group of investigational sites. Recruitment of CRAs may be directly into a pharmaceutical company or into a Contract Research Organisation (CRO) which can plan, organise and/or conduct clinical trials on behalf of pharmaceutical companies. This booklet aims to provide ideas, information and guidance to those who might be interested in becoming a CRA, either within the Pharmaceutical Industry or within the Pharmaceutical Service Industry. Existing CRAs and colleagues may wish to give this booklet to those who express an interest in the CRA role. Careers Advisors, recruitment and Human Resources may wish to use this booklet to provide information, in a concise and relevant form, to those actively seeking a CRA position. To be a CRA 7
8 The Clinical Research Associate (CRA) Definition Clinical Research Associates are research professionals carrying out activities that may include investigational site selection, set up, initiation, monitoring and close-out, and can be involved in all operational aspects of the clinical phases of drug development. Role and Functions Clinical Research Associates are also known as CRAs, Clinical Research Monitors, Clinical Trial Monitors, Clinical Research Scientists etc. and the titles used vary from company to company. CRAs can be full-time or part-time and based in the field (home based) or in the office, either at the Sponsor/CRO office or at the investigational site. It is quite common to work on 6-12 month contracts with a company rather than as a permanent employee. Some CRAs therefore choose to work freelance for a variety of clients once they have gained enough experience. They may be involved in all phases of clinical research and at all stages of a particular trial, within a variety of therapeutic areas. Although the role and functions of CRAs will vary slightly from company to company, it is likely that a CRA will be involved in all activities required to set up, conduct and complete a clinical trial, including: Investigator identification and selection. Co-ordination of ethics committee and regulatory authority applications and approvals. Pre trial procedures including collation of necessary documentation. This usually involves a visit to the investigational site to assess their suitability to conduct the trial. To be a CRA 8
9 Organisation, attendance and/or presentations at investigator meetings. Initiation, monitoring and close-out of investigational sites (see Table 1). Training of site staff to trial specific and industry standards. Supervision and/or distribution of trial supplies, including the trial drug (investigational medicinal product). Protocol and Case Report Form (CRF) development. Archiving of trial documentation and correspondence. Clinical Trial Report and manuscript for publication (occasional). To be a CRA 9
10 Table 1 Initiation: Monitoring visit: Close-out visit: This is the visit to the investigational site at the very beginning of the trial that is carried out once all the appropriate approvals and paperwork are in place. This involves meeting with all the appropriate departments/site staff within the investigational site (e.g. pharmacy, laboratories, radiology etc) This is to ensure that they are aware of the trial protocol, procedures, ICH GCP and the logistical aspects of running the trial, to name a few. This can involve speaking one to one, or speaking in front of a group about the trial. These usually take place over one to two days at the investigational site approximately every four to six weeks depending on the trial, therapeutic area and the number of subjects taking part. Regular monitoring visits are made by a CRA to verify (SDV) and collect data recorded on CRFs, ensure prompt reporting of adverse events, maintain drug accountability, ensure adherence to the trial protocol, Good Clinical Practice (GCP) and Standard Operating Procedures (SOPs), encourage further subject recruitment, identify and resolve problems. This is the very last visit that is made to an investigational site at the end of the trial once all subjects have finished the trial and the database has been cleaned by data management. This will involve ensuring that 100% Investigational Medicinal Product (IMP) accountability, checking all the paperwork is in place and that any remaining trial supplies have been removed/destroyed. This meeting will always involve a final discussion with the investigator at the investigational site to remind them of their responsibilities for archiving and retaining the trial documents according to ICH GCP. To be a CRA 10
11 Education and Training Opportunities Pharmaceutical companies and CROs provide on-the-job training plus, in some cases, a structured system of internal training courses and access to external training courses. Wide experience is gained by working in different phases of clinical research and different therapeutic areas. External training courses available include: The Institute of Clinical Research offers one day courses such as So you want to be a CRA?, Introduction to Clinical Research, The Proactive CRA. Formal academic qualifications such as a PgCert, a Diploma, an MSc and PhD in Clinical Research are available through the Institute and Cranfield University. There are also other suppliers who will be found on the Institute website from autumn 05. There are training programmes for graduates to become CRAs in a combined environment of training and job placements. ICR is about to launch a Resourcing Forum and later in 2005 the ICR website will list all the suppliers with web links for those interested in comparing opportunities. Contact ICR for the latest information. Qualifications, Experience and Skills Qualifications: Most CRA positions require as a minimum a BSc in biological/life sciences, pharmacy, chemistry or related medical field or a nursing qualification. To be a CRA 11
12 Experience: To get your first job it is essential to do your homework and have knowledge of: The pharmaceutical and services industry. The job role itself and what it might entail. The industry regulations that must be followed (e.g. International Conference on Harmonisation for Good Clinical Practice (ICH GCP), EU Clinical Trials Directive (2001/20/EC), EU Directive on GCP (2005/28/EC). Demonstrate an understanding of the travelling that can be involved in a CRA role. Essential Skills of a CRA include: Organisational skills (including multi-tasking). Methodical and meticulous nature with attention to detail. Administrative and writing skills. Time management. Communication skills. Interpersonal skills. Diplomacy. Ability to motivate and organise others. Flexibility and versatility. IT skills. To be a CRA 12
13 Career Development The CRA role is varied and the career development can vary from company to company. Some CRAs begin their career in data management or as Clinical Trial Administrators (CTAs) before gaining a Junior CRA position. Others may have gained a background in areas involving pre-clinical research. The Institute of Clinical Research offers members an active continuous professional development (CPD) scheme, which is strongly encouraged when you are looking for a career as a CRA and during your career to improve your skills and expertise. A guidance of the career path as a CRA is given below. CRA Level I: Functions may include: Pre-trial procedures including collation of necessary documentation to start a trial. Initiation, monitoring and close-out of investigational sites, usually accompanied by a more experienced CRA for the first few months. (see Table 1) Archiving of trial documentation and correspondence. CRA Level II: Role Investigator identification and selection. Co-ordination of ethics committee and regulatory authority applications and approvals. To be a CRA 13
14 Supervision and/or distribution of trial supplies, including the trial drug (investigational medicinal product). Organisation, attendance and/or presentations at investigator meetings. CRA Level III or Senior CRA: This more senior role may cover any of the above tasks but may also include supervising, training and mentoring junior members of staff, and project management of whole trials within a country/internationally. You may also get involved in protocol and Case Report Form (CRF) development and other medical writing projects. How do I find a CRA Position? Positions can be found via: Advertisements in journals such as Clinical Research focus (the journal of The Institute of Clinical Research). Internet searches. Recruitment Agencies. Recruitment Fairs. Contacts within the contract research or pharmaceutical industries. Speculative application to pharmaceutical or contract research companies. Internal moves from other positions within the same company. To be a CRA 14
15 The Institute of Clinical Research CRA Subcommittee The CRA Subcommittee comprises of volunteers from pharmaceutical companies, CROs and investigational sites. Since it was established in 2004, the CRA Subcommittee has focused on defining and promoting the role of the CRA across clinical research both within the UK and worldwide. Anyone wishing to find out more about the CRA subcommittee, or wishing to join, please contact The Institute of Clinical Research. To be a CRA 15
16 Would you like to find out more? Below is a brief overview of the drug research and development process. Drug Research and Development The objectives of drug research and development include the production of safe, effective and profitable drugs of high quality for use by the medical profession. The cost of developing a new substance into a licensed medicine is huge (approximately 360 million) and can take between 10 and 12 years. The risk of early failure is great; only 1 new compound in 10,000 discovered will reach the stage where a marketing license is approved. Costs and risks must be covered by sales of the new drug and other drugs in a company s portfolio. The pharmaceutical industry is strictly regulated, with laws limiting prices, profit margins and promotion of products. Regulatory authorities keep a watchful eye on research and on the marketing of new and existing drugs. International research and marketing are also controlled by the authorities in other countries, e.g. the Food and Drug Administration (FDA) in the USA and the European Medicines Evaluation Agency (EMEA) in Europe. In Europe, EFPIA (the European Federation of Pharmaceutical Industries Association) represents the manufacturers of prescription medicines and provides internal regulation of the industry. In the UK this role is played by the ABPI (Association of British Pharmaceutical Industry). To be a CRA 16
17 Phases of Clinical Research An important objective of clinical research is to ensure that marketed drugs are safe and effective. All drugs have side-effects, many of which are undesirable. Some drugs carry a risk of toxic effects. It is important to weigh up the risk to benefit ratio. Unwanted side-effects and a risk of toxicity may be acceptable for a drug used to treat serious, life-threatening diseases such as cancer. The same unwanted effects and risks would be unacceptable to subjects, and therefore to the regulatory authorities, if the drug were to be used to treat a minor illness. Women who are pregnant or lactating, or who are likely to become pregnant, are excluded from most clinical research, so as to avoid the risk of any unknown effects on the child. A pharmaceutical company will take care to plan a clinical research strategy for a new drug, so as to minimise the time and cost of obtaining a Product License. The strategy may involve several phases of clinical research, with at least one trial within each phase: Pre-Clinical Research Prior to initial use in trial subjects, potential new medicines are tested exhaustively to assess mode of action, potential therapeutic benefit and toxic effects at a range of doses. Information is gathered on the absorption, distribution, metabolism and excretion of the compound. Phase I (Human Pharmacology) trials involve the first exposure of a new active compound or new formulation to human subjects. Trials are designed to make a preliminary assessment of safety, pharmacokinetics and pharmacodynamics. Trial subjects are usually healthy volunteers, often young males. Phase II (Therapeutic Exploratory) trials are therapeutic, assessing efficacy and safety in a small number of subjects with the relevant illness or condition. Entry criteria are very To be a CRA 17
18 strict and limited so as to ensure a well-defined trial population. Here the aims are to demonstrate a proof of concept. Phase III (Therapeutic Confirmatory) trials assess short- and long-term safety and efficacy in larger numbers of subjects. Entry criteria are well defined but may be less limiting than in Phase II. Trials usually involve a placebo and/or a competitor drug for comparison, with blinded randomisation of treatment allocation. These trials usually provide the pivotal data needed for a Marketing Authorisation Application. Phase IV (Therapeutic Use) trials are conducted after the Marketing Authorisation Application has been granted and often coincide with the launch of the new drug onto the market. Trials involve large number of subjects; the entry criteria are less limiting so as to encompass a broad selection of subjects. Trials are usually comparative with a competitor drug or occasionally placebo control. The aim is to provide more safety and efficacy information and sometimes to change or expand the indication for use so as to increase market share. Post Marketing Surveillance (PMS) trials involve very large number of subjects from a diverse general population. Important information is collected on subjects to whom the drug is administered. The aim is to continue the monitoring of drug safety and to highlight any rare side-effects which might only come to light after large scale use. Organising a Clinical Trial Once a company has decided on the type of trial required, a trial protocol will be drafted with input from regulatory experts, clinical research personnel, physicians, statisticians and biometricians. A steering committee may be set up to decide on the best trial design To be a CRA 18
19 to provide the necessary information. The trial design may be single-blind or double-blind, with a placebo or active control and parallel or cross-over treatment. The content of the final protocol will be mirrored in the design of the Case Report Forms (CRFs), used by investigators to record the subject data collected during the trial. The protocol and CRF and any later amendments are put through rigorous internal and external approval processes. Investigator sites are carefully chosen and briefed to ensure that each has adequate facilities and enough staff, time and enthusiasm to carry out the trial procedures correctly. The surgery list or hospital population must be such that suitable subjects can be recruited at an acceptable rate. Each site must be provided with adequate trial supplies, including the trial drug and any comparators with correct labeling and procedures for maintaining any blinding and ensuring accurate accountability. The clinical research industry is controlled by strict ethical restrictions. Since 1 st May 2004, the ethics process has undergone major structural and operational changes, to bring the processes into line with the EU Directive 2001/20/EC. All potential clinical trials must be approved by a research ethics committee (REC) before participants can be recruited into the trial. Audits are often performed by Quality Assurance personnel from the sponsor and/ or contract organisation. Trials can also be inspected by the Regulatory Authority at any time before or after a Marketing Authorisation Application has been made. A Regulatory Authority inspection can also take place after the trial has finished and all documents have been archived. To be a CRA 19
20 Conclusions If you are enthusiastic, logical, methodical and looking for career variety then the CRA role may offer you a career opportunity within the clinical research industry. It is hoped that this booklet has helped clarifying the role and responsibilities of the CRA. If this could be you and you would like to find more information than what is provided in this booklet, or you wish to become a member of The Institute of Clinical Research, please visit the website of The Institute of Clinical Research: To be a CRA 20
21 Organisations and Websites ICR The Institute of Clinical Research ABPI Association of the British Pharmaceutical Industry: ACDM Association of Clinical Data Management BARQA British Association of Research Quality Assurance. COREC Central Office for Research Ethics committees EFPIA The European Federation of Pharmaceutical Industries and Associations EMEA The European Medicines Agency EUDRA European Commission DG and Enterprise Eur-Lex European Union legislation MRC Medical Research Council To be a CRA 21
22 MHRA Medicines and Healthcare products Regulatory Agency NHS R&D Department of Health Research & Development TOPRA The Organisation for Professionals in Regulatory Affairs To be a CRA 22
23 References Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. Official Journal of the European Communities L121/34-44 Commission Directive 2005/28/EC on the laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products. European Commission, Official Journal of the European Communities L91/13-19 ICH Harmonised Tripartite Guideline for Good Clinical Practice, ICH Secretariat, 1996 World Medical Association Declaration of Helsinki Ethical Principles for Medical Research Involving Human Subjects, South Africa, World Medical Association Declaration of Helsinki Ethical Principles for Medical Research Involving Human Subjects, Edinburgh, World Health Organisation, No. 850, Annex 3, WHO Technical Report Series: Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products, WHO, 1993 To be a CRA 23
24 Glossary Active control An active, as opposed to dummy, treatment allocated to one group of subjects to act as a reference for comparison with the trial drug. Adverse event Any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Archiving The long term storage and retrieval of trial documentation. Audit A systematic and independent examination of trial related activities and documents to determine whether the evaluated trial related activities were conducted, and the data were recorded, analysed and accurately reported according to the protocol, sponsor s standard operating procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s). To be a CRA 24
25 Case Report Form (CRF) A printed or electronic document designed to record all of the information required by the protocol to be reported to the sponsor on each trial subject. Centre (or Site) The location(s) where the trial-related activities are actually conducted. Trials may be at one site or multisite. Comparator trial A trial in which subjects are allocated to more than one alternative active treatment and the alternatives are then compared. Competitor drug An alternate treatment, which is used for the same indication as that proposed for the trial drug and would therefore, compete for market share. Clinical Trial Application (CTA) The application form for applying for regulatory approval, required prior to the start of any trial, in line with the EU Directive Clinical Trial Administrator (CTA) Someone who administers, maintains and co-ordinates the logistical aspects of clinical trials according to Good Clinical Practice and relevant SOPs and acts as a pivotal point of contact for the clinical trial team To be a CRA 25
26 Clinical Research Clinical research is the design, management, conduct and reporting of an evaluation of the impact of a therapeutic intervention. Clinical research aims to specifically answer a question about treating a disease through human participation, records based trials, clinical samples or in technology development for clinical use. It conducts the research, within the confines of current legislation and medical ethics, according to good clinical practice. Human participation: trials which require the intervention to be tested using direct contact with human participants (clinical trial). Records based trials: require access to personal data on health or lifestyle without direct contact (health economic trials or health services research). Clinical samples: trials which involve laboratory trials on human material. Technology development for clinical use: instrument development for diagnostic or surgical use or new techniques. Clinical Research Associate Clinical Research Associates are research professionals carrying out activities that may include investigational site selection, set up, initiation, monitoring and close-out, and can be involved in all operational aspects of the clinical phases of drug development Clinical Research Organisation (CRO) A person or an organisation (commercial, academic or other) contracted by the sponsor to perform one or more of a sponsor s trial related duties and functions. To be a CRA 26
27 Clinical Trial A type of research trial that tests an investigational new drug or method to see how well it works on people. Continuous Professional Development (CPD) The planned acquisition of knowledge, experience and skills and the development of personal qualities for the execution of professional duties and for career management throughout working life. Cross-over trial A trial in which subjects receive one treatment followed by another, the treatments often being separated by a washout period when the subjects receive no treatment or placebo. Data management All procedures for handling and processing data collected during a trial. Double-blind A system to ensure that the treatment allocated is unknown to both theinvestigator and the subject. Entry criteria Rules to ensure that suitable subjects are selected for entry into a trial. Inclusion criteria describe subjects who are suitable in terms of age, sex, disease. Exclusion criteria describe subjects who should not be selected, so as to avoid various health risks and to maximise the validity of the trial results. To be a CRA 27
28 Generic The non-branded compound and name by which it is commonly known. Genetic engineering The science, which, includes the mass production of useful biological substances by modification and transplant of genetic material. Good Clinical Practice (GCP) A standard for the design, conduct performance, monitoring auditing recording analyses and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate and that the rights, integrity and confidentiality of trial subjects are protected. Institute of Clinical Research, The (ICR) The premier organisation for professionals in all aspects of clinical research. International Conference on Harmonisation (ICH) The ICH GCP guideline was developed to provide a unified standard for the European Union, Japan and United States, as well as those of Australia, Canada, the Nordic countries and the World Health Organisation (WHO). Indication The condition or disease for which a licensed or trial treatment is to be used. To be a CRA 28
29 Informed consent 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. Investigational Medicinal Product (IMP) A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorisation when used or assembled in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use. Investigator A person 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. 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). New Chemical Entity A newly developed compound. To be a CRA 29
30 Parallel trial A trial in which two or more separate groups of subjects are used to compare two or more treatments; each group receives a different, single treatment, usually allocated randomly. Patent protection The exclusive right to produce a particular compound or formulation, such that no other company can produce a copy. Pharmacology The trial of drugs. Pharmacodynamics The effects of a drug on the physiology of the body. Pharmacokinetics The trial of Absorption, Distribution, Metabolism and Excretion (ADME) of drugs when administered to humans or animals. Pivotal trial A trial conducted to GCP Guidelines and providing crucial efficacy and safety data to Regulatory Authorities. Placebo An inactive substance, usually formulated to be identical to the trial treatment, used to provide reference data, which controls psychosomatic effects and designed to minimise investigator and/or subject bias towards a treatment. To be a CRA 30
31 Product License Regulatory approval needed to market, advertise, sell and supply medicinal products. Protocol A document that describes the objective(s), design, methodology, statistical considerations, and organisation 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. Randomisation The unpredictable allocation of subjects to different treatments to minimise the possibility of bias. Receptors Chemical groupings/molecular structures, within or on the surface of a body cell, to which other specific chemical groupings/molecular structures can attach to produce a particular effect. Safety/Tolerability A lack of adverse events, serious events, toxicity associated with a treatment. Shelf life The period for which a product is confirmed as being fit for its purpose. Side-effects Effects other than those intended to treat the indication. To be a CRA 31
32 Single-blind A system to ensure that the treatment allocated is unknown to the subject. In this case the investigator does know which treatment the subject is taking. Source Data Verification (SDV) Verifying that all information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial are accurately reported in the Case Report Form (CRF). Sponsor An individual, company, institution, or organisation which takes responsibility for the initiation, management, and/or financing of a clinical trial. Standard Operating Procedure A detailed written description of how a unit executes a particular procedure or method. It is intended to standardize the performance of the procedure. Comprehensive and controlled documents, generally covered under the company s quality system and thus kept fully up to date. Steering committee A group of medical and research experts, who review, discuss and advise on the development of the trial protocol and/or aspects of the ongoing trial. Subject A subject is an individual who participates in a clinical trial who could be a healthy volunteer or a patient being treated in a GP surgery or hospital. To be a CRA 32
33 Toxicology The trial of poisonous effects of chemicals on the body. Trial Master File (TMF) The file (s) containing all the essential documentation for a trial. To be a CRA 33
34 About ICR Publishing The Institute of Clinical Research (ICR) is committed to developing information resources, and encouraging information sharing, amongst the profession and related areas in research and development. ICR Publishing produces the ICR Reports, booklets and the Monograph series. Our publications are written by key people in the field who want to share their knowledge with others involved in research and development. About the publications The ICR is responsible for publishing a wide range of material: The Monograph series offers in depth information on issues in clinical research Smaller booklets providing advice on careers, roles and regulations in the industry The ICR Reports, which are available free to download from the website. These reports offer up to date guidance on issues to anyone interested in this sector About The Institute of Clinical Research ICR has been in existence since 1978 and our vision is To be internationally recognised as the premier organisation for clinical research, respected as a key influencer, promoting knowledge and understanding by engaging the healthcare community and the general public.
Sheffield Kidney Institute. Planning a Clinical Trial
Planning a Clinical Trial Clinical Trials Testing a new drug Ethical Issues Liability and Indemnity Trial Design Trial Protocol Statistical analysis Clinical Trials Phase I: Phase II: Phase III: Phase
More informationEU DIRECTIVE ON GOOD CLINICAL PRACTICE IN CLINICAL TRIALS DH & MHRA BRIEFING NOTE
EU DIRECTIVE ON GOOD CLINICAL PRACTICE IN CLINICAL TRIALS DH & MHRA BRIEFING NOTE Purpose 1. The Clinical Trials Directive 2001/20/EC heralds certain additional responsibilities for the Medicines and Healthcare
More informationIntroduction 2. 1. The Role of Pharmacy Within a NHS Trust 3. 2. Pharmacy Staff 4. 3. Pharmacy Facilities 5. 4. Pharmacy and Resources 6
Index Index Section Page Introduction 2 1. The Role of Pharmacy Within a NHS Trust 3 2. Pharmacy Staff 4 3. Pharmacy Facilities 5 4. Pharmacy and Resources 6 5. Prescription Charges 7 6. Communication
More informationHistory and Principles of Good Clinical Practice
History and Principles of Good Clinical Practice Cristina E. Torres, Ph.D. Social Science Professor, UPM-NIH FERCAP Coordinator ICH: International Conference on Harmonization GCP: Good Clinical Practices
More informationTRIAL MASTER FILE- SPONSORED
gsop-06-04 - Management of TMF for ENHT/ WHHT Sponsored CTIMPs Page 1 of 16 Hertfordshire Hospitals R&D Consortium Incorporating West Herts Hospitals NHS Trust and East & North Herts NHS Trust TRIAL MASTER
More informationCLINICAL TRIALS WITH MEDICINES IN EUROPE
CLINICAL TRIALS WITH MEDICINES IN EUROPE REGULATORY FRAMEWORK FOR CLINICAL TRIALS WITH MEDICINES IN EUROPE The pharmaceutical industry is the most highly regulated sector in Europe. The Commission has
More informationJob Profile Clinical Research Associate III (CRA)
PART 1 - PROFILE You are an experienced CRA with a strong background in Clinical Research who is passionate about drug development and are seeking a challenging and rewarding career in a quality focussed
More informationCONTROLLED DOCUMENT- DO NOT COPY STANDARD OPERATING PROCEDURE. STH Investigator
Research Department STANDARD OPERATING PROCEDURE STH Investigator Archiving of Essential Documentation Generated During Clinical Research SOP Number A127 Version Number V1.3 Effective Date Author Zoe Whiteley
More informationHealth Care Job Information Sheet #20. Clinical Research
Health Care Job Information Sheet #20 Clinical Research A. Background B. Occupations 1) Clinical Research Associate (Study Monitor) 2) Clinical Research Coordinator 3) Other positions in the field C. Labour
More informationManaging & Validating Research Data
Research Management Standard Operating Procedure ISOP-H02 VERSION / REVISION: 2.0 EFFECTIVE DATE: 01 03 12 REVIEW DATE: 01 03 14 AUTHOR(S): CONTROLLER(S): APPROVED BY: Information Officer; NBT Clinical
More informationICH CRA Certification Guide March 2009
ICH CRA Certification Guide March 2009 ICH CRA CERTIFICATION GUIDE... 1 GENERAL INFORMATION... 2 BENEFITS OF CERTIFICATION... 2 INDUSTRY RECOGNITION... 2 ABOUT THE EXAM... 2 CRA DEFINITION... 2 REQUIREMENTS
More informationArchiving of Research Documentation
Suspension, Termination & Completion Standard Operating Procedure VERSION / REVISION: 2.0 EFFECTIVE DATE: 28 05 12 REVIEW DATE: 28 05 14 AUTHOR(S): CONTROLLER: APPROVED BY: Clinical Trials Manager; Recruitment
More informationA responsible approach to clinical trials. Bioethics in action
A responsible approach to clinical trials Bioethics in action What is bioethics? At Novo Nordisk bioethics is the expression used for all ethical issues related to the use of life science technologies
More informationMRC. Clinical Trials. Series MRC GUIDELINES FOR GOOD CLINICAL PRACTICE IN CLINICAL TRIALS. Medical Research Council
MRC Clinical Trials Series MRC GUIDELINES FOR GOOD CLINICAL PRACTICE IN CLINICAL TRIALS 1998 Medical Research Council MRC GUIDELINES FOR GOOD CLINICAL PRACTICE IN CLINICAL TRIALS 1998 MRC GUIDELINES FOR
More informationThis is a controlled document. The master document is posted on the JRCO website and any print-off of this document will be classed as uncontrolled.
This is a controlled document. The master document is posted on the JRCO website and any print-off of this document will be classed as uncontrolled. Researchers and their teams may print off this document
More informationArchiving of Clinical Trial Data and Essential Documentation JCTO/CT/SOP 4.0. Joint Clinical Trials Office. Stuart Hatcher, JCTO Archivist
Archiving of Clinical Trial Data and Essential Documentation Policy Details Document Type Standard Operating Procedure Document name Change History Date Version Number JCTO/CT/SOP 4.0 Version Final v 2.0-09/11/2010
More informationTo Certify or Not to Certify
To Certify or Not to Certify Sandra Halvorson, BA, CCRP Clinical Research Coordinator II CIBMTR Minneapolis Campus Sue Logan, BS, CCRP Clinical Research Coordinator II CIBMTR Minneapolis Campus November
More informationTo Certify or Not to Certify Sandra Halvorson, BA, CCRP
To Certify or Not to Certify Sandra Halvorson, BA, CCRP Clinical Research Coordinator II CIBMTR Minneapolis Campus Sue Logan, BS, CCRP Clinical Research Coordinator II We have no financial relationships
More informationGENERAL CONSIDERATIONS FOR CLINICAL TRIALS E8
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE GENERAL CONSIDERATIONS FOR CLINICAL TRIALS E8 Current
More informationStandard Operating Procedure. Clinical Trial Authorisation
Standard Operating Procedure for Clinical Trial Authorization Scope This SOP has been written to describe the procedure undertaken to apply for Clinical Trial Authorisation from Competent Authorities in
More informationGlossary of Clinical Trial Terms
Glossary of Clinical Trial Terms ADVERSE REACTION: (Adverse Event): Also known as side effects, adverse reactions include any undesired actions or effects of the experimental drug or treatment. Experimental
More informationEthics and Scientific Oversight for Phase 1 Clinical Trials in Hong Kong. Sydney TANG Chairman, HKU/HA HKW IRB November 21, 2015
Ethics and Scientific Oversight for Phase 1 Clinical Trials in Hong Kong Sydney TANG Chairman, HKU/HA HKW IRB November 21, 2015 Clinical Trials at HKU Phase 1 Phase II Phase III Phase IV Conducted on patient
More informationThe Clinical Trials Process an educated patient s guide
The Clinical Trials Process an educated patient s guide Gwen L. Nichols, MD Site Head, Oncology Roche TCRC, Translational and Clinical Research Center New York DISCLAIMER I am an employee of Hoffmann-
More informationClinical Research Associate (CRA) - A Growing Career Path in Biotechnology / Pharmaceutical Industry
Clinical Research Associate (CRA) - A Growing Career Path in Biotechnology / Pharmaceutical Industry By http://www.clinicalresearchassociate cra.com/studyguide/ A clinical research associate (CRA) is a
More informationUK Implementation of the EU Clinical Trial Directive 2001/20/EC:
UK Implementation of the EU Clinical Trial Directive 2001/20/EC: GCP Aspects. Dr. Colin Wilsher, FRQA. BARQA GCP Committee Chairman; & Pfizer Worldwide Development Quality Assurance. GIQAR, Roma, October
More informationA Guide to Clinical Trials
A Guide to Clinical Trials For young people with cancer and their parents Children s Cancer and Leukaemia Group www.cclg.org.uk Original booklet produced in conjunction with the CCLG Patient Advocacy Committee.
More informationSubject: No. Page PROTOCOL AND CASE REPORT FORM DEVELOPMENT AND REVIEW Standard Operating Procedure
703 1 of 11 POLICY The Beaumont Research Coordinating Center (BRCC) will provide advice to clinical trial investigators on protocol development, content and format. Upon request, the BRCC will review a
More information1. Study title Is the title self explanatory to a layperson? If not, a simplified title should be included.
These guidelines apply to all research projects where human subjects are involved in the study GUIDELINES FOR RESEARCHERS PATIENT INFORMATION SHEET & CONSENT FORM The guidance, which follows, applies primarily
More information20 & 21 October 2005 Clinical trials Risk issues within a wider Europe. Adrien Collovray Marsh Life Science Conference 2005 Berlin, Germany
20 & 21 October 2005 Clinical trials Risk issues within a wider Europe Adrien Collovray Life Science Conference 2005 Berlin, Germany Clinical trials EC Directive on clinical trials Insurance Requirements
More informationGuidance on Investigational Medicinal Products (IMPs) and other medicinal products used in Clinical Trials
EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL Consumer goods Pharmaceuticals Guidance on Investigational Medicinal Products (IMPs) and other medicinal products used in Clinical Trials
More informationClinical Trial Oversight: Ensuring GCP Compliance, Patient Safety and Data Integrity
Clinical Trial Oversight: Ensuring GCP Compliance, Patient Safety and Data Integrity Michelle Quaye Regulatory Manager, Advanced Therapy Trials University College London Overview The Principles of Good
More informationMedicine Safety Glossary
The following definitions are provided as a resource to supplement the information provided in the Medicine Safety Education section of the Pfizer.com Web site; they are not intended as a comprehensive
More informationManaging Risk in Clinical Research. Dr Martha J Wrigley R&D Manager Senior Visiting Fellow University of Surrey
Managing Risk in Clinical Research Dr Martha J Wrigley R&D Manager Senior Visiting Fellow University of Surrey Aim of the session To explore the risks associated with clinical research and understand how
More informationContents. Project Management: August 2005 Page 2 Clinical Research Operational Standards for Professional Practice for Professional Practice
Project Management: August 2005 Contents Introduction........................................................... 4 About this standard: what is the importance of project management?................. 4
More informationComparative analysis between the possible regulatory approaches to GMP compliance TITOLO PRESENTAZIONE
Comparative analysis between the possible regulatory approaches to GMP compliance TITOLO PRESENTAZIONE Dr. Fulvio CARLOTTI, GNOSIS SpA, Corporate QA Director September 26, 2014 Scope of GMP GMP compliance
More informationThe Management of Pharmaceuticals in the Environment (PIE) FAQ. Key questions and answers. Q: How do pharmaceuticals get into the environment?
The Management of Pharmaceuticals in the Environment (PIE) FAQ Key questions and answers Q: How do pharmaceuticals get into the environment? A: Like many foods and supplements that are consumed by humans
More informationThe Study Site Master File and Essential Documents
The Study Site Master File and Essential Documents Standard Operating Procedure Office of Health and Medical Research Queensland Health SOP reference: 002 Version number: 1 Effective date: 01 June 2010
More informationRECOMMENDATION ON THE CONTENT OF THE TRIAL MASTER FILE AND ARCHIVING
RECOMMENDATION ON THE CONTENT OF THE TRIAL MASTER FILE AND ARCHIVING July 2006 TABLE OF CONTENTS Page 1. Introduction 2 2. Scope 2 3. Documents to be archived 2 4. Quality of essential documents 10 5.
More informationGuidance Notes for Applicants of the Certificate for Clinical Trial on Medical Device
Guidance Notes for Applicants of the Certificate for Clinical Trial on Medical Device List of Contents Page 1. Introduction 1.1 The Medical Device Administrative Control System and the 3 proposed legislation
More informationAdvancing research: a physician s guide to clinical trials
Advancing research: a physician s guide to clinical trials Recruiting and retaining trial participants is one of the greatest obstacles to developing the next generation of Alzheimer s treatments Alzheimer
More informationNATIONAL HEALTH COUNCIL RESOLUTION Nº 251, DATED 7 AUGUST 1997
NATIONAL HEALTH COUNCIL RESOLUTION Nº 251, DATED 7 AUGUST 1997 Plenary of the National Health Council in its 15 th Special Meeting, held on 5 August 1997, in the exercise of its competencies, as set forth
More informationICH Topic E 8 General Considerations for Clinical Trials. Step 5 NOTE FOR GUIDANCE ON GENERAL CONSIDERATIONS FOR CLINICAL TRIALS (CPMP/ICH/291/95)
European Medicines Agency March 1998 CPMP/ICH/291/95 ICH Topic E 8 General Considerations for Clinical Trials Step 5 NOTE FOR GUIDANCE ON GENERAL CONSIDERATIONS FOR CLINICAL TRIALS (CPMP/ICH/291/95) TRANSMISSION
More informationA clinical research organization
A clinical research organization About Us State of art facility. All clinical trials carried out in accordance with ICH GCP guidelines. Quality services within stipulated time period. Team of experienced
More informationEssentials of RESEARCH GOVERNANCE
Promoting Good Practice in Research Essentials of RESEARCH GOVERNANCE Information for Researchers, Students and Support Staff involved in Health & Social Care Research 2005 Reproduced with the permission
More informationNot All Clinical Trials Are Created Equal Understanding the Different Phases
Not All Clinical Trials Are Created Equal Understanding the Different Phases This chapter will help you understand the differences between the various clinical trial phases and how these differences impact
More informationHollie Goddard Sr. IRB Coordinator McKesson Specialty Health
Hollie Goddard Sr. IRB Coordinator McKesson Specialty Health We are responsible for acquiring, analyzing, and protecting medical information vital to providing quality patient care HIM professionals ensure
More informationSTANDARD OPERATING PROCEDURE FOR RESEARCH. Management of Essential Documents and Trial Folders
STANDARD OPERATING PROCEDURE FOR RESEARCH Management of Essential Documents and Trial Folders Author Linda Ward Author s Job Title QA Coordinator Division Department Version number 2 Ref SOP/CLN/001/2
More informationClinical Trials and Safety Surveillance of Drugs in Development
Clinical Trials and Safety Surveillance of Drugs in Development Hoda Eid, M.Sc., Ph.D. Manager, ADR Unit Office of Clinical Trials Therapeutic Products Directorate hoda_eid@hc-sc.gc.ca Overview Clinical
More informationClinical trials regulation
Clinical trials regulation The Proposal for a Regulation of the European Parliament and of the Council on Clinical Trials on Medicinal Products for Human Use and Repealing Directive 2001/20/EC an update
More informationSharon H. Johnson, BS, MS 123 Main Street Capital City, VA 00000 Phone: 434-555-1234 Email: shjohnson@email.com
SAMPLE CRA CV Sharon H. Johnson, BS, MS 123 Main Street Capital City, VA 00000 Phone: 434-555-1234 Email: shjohnson@email.com Education: Masters of Science, Healthcare Administration, Capital City University,
More informationStandard Operating Procedure on Training Requirements for staff participating in CTIMPs Sponsored by UCL
Page 1 of 10 Standard Operating Procedure on Training Requirements for staff participating in CTIMPs Sponsored by UCL SOP ID Number: Effective Date:01/08/2012 Version Number & Date of Authorisation: V02,
More informationQualified Persons in the Pharmaceutical Industry Code of Practice 2009, updated August 2015
Qualified Persons in the Pharmaceutical Industry Code of Practice 2009, updated August 2015 *QP Code of Practice 2008 updated Aug15 Page 1 of 13 Code of Practice for Qualified Persons 1. INTRODUCTION 2.
More informationEssential Documentation and the Creation and Maintenance of Trial Master Files
This is a controlled document. The master document is posted on the JRCO website and any print-off of this document will be classed as uncontrolled. Researchers and their teams may print off this document
More informationLaurie Shaker-Irwin, Ph.D., M.S. Co-Leader, Regulatory Knowledge and Research Ethics UCLA Clinical and Translational Science Institute
Laurie Shaker-Irwin, Ph.D., M.S. Co-Leader, Regulatory Knowledge and Research Ethics UCLA Clinical and Translational Science Institute Understand the protocol completely Recognize institutional polices
More informationGOOD CLINICAL PRACTICE*)
GOOD CLINICAL PRACTICE*) Guideline Title Good Clinical Practice*) Legislative basis Directive 75/318/EEC as amended Date of first adoption July 1990 This version July 1996 Date of entry into January 1997
More informationHaving regard to the Treaty establishing the European Community, and in particular Article 95 thereof,
L 121/34 DIRECTIVE 2001/20/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to
More informationROLES, RESPONSIBILITIES AND DELEGATION OF DUTIES IN CLINICAL TRIALS OF MEDICINAL PRODUCTS
ROLES, RESPONSIBILITIES AND DELEGATION OF DUTIES IN CLINICAL TRIALS OF MEDICINAL PRODUCTS STANDARD OPERATING PROCEDURE NO SOP 09 DATE RATIFIED 4/7/13 NEXT REVIEW DATE 4/7/14 POLICY STATEMENT/KEY OBJECTIVES:
More informationOverview of Drug Development: the Regulatory Process
Overview of Drug Development: the Regulatory Process Roger D. Nolan, PhD Director, Project Operations Calvert Research Institute November, 2006 Adapted from course taught by Cato Research Background: Roger
More informationOperational aspects of a clinical trial
Operational aspects of a clinical trial Carlo Tomino Pharm.D. Coordinator Pre-authorization Department Head of Research and Clinical Trial Italian Medicines Agency Mwanza (Tanzania), June 11, 2012 1 Declaration
More informationFARMAINDUSTRIA S STANDARD CODE ON PERSONAL DATA PROTECTION IN CLINICAL RESEARCH AND PHARMACOVIGILANCE
FARMAINDUSTRIA S STANDARD CODE ON PERSONAL DATA PROTECTION IN CLINICAL RESEARCH AND PHARMACOVIGILANCE - 2 - Registered at the Spanish Data Protection Agency Registry by means of the decision dated 17 June
More informationThis document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
2001L0020 EN 07.08.2009 002.001 1 This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents B DIRECTIVE 2001/20/EC OF THE EUROPEAN PARLIAMENT
More informationINTERIM SITE MONITORING PROCEDURE
INTERIM SITE MONITORING PROCEDURE 1. PURPOSE The purpose of this SOP is to describe the interim monitoring procedures conducted at Institution, according to GCP and other applicable local regulations.
More informationDefinition of Investigational Medicinal Products (IMPs) Definition of Non Investigational Medicinal Products (NIMPs)
EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL Consumer goods Pharmaceuticals Definition of Investigational Medicinal Products (IMPs) Definition of Non Investigational Medicinal Products
More informationEUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL
EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Health systems and products Medicinal products authorisations, EMA Brussels, 27.03.2014 ENTR/6283/00 Rev 4 orphan\guidelines\format content
More informationResearch Study Close-down and Archiving Procedures
Title: Outcome Statement: Research Study Close-down and Archiving Procedures To inform researchers of the process for closing down research studies, retaining and storing research materials in the Trust.
More informationGuidance notes. for Patient Safety and Pharmacovigilance in Patient Support Programmes
Guidance notes for Patient Safety and Pharmacovigilance in Patient Support Programmes 9 May 2011 Approval Status Authors The ABPI Pharmacovigilance Expert Network Change History N/A Approval Date 9 May
More informationInsurance and compensation in the event of injury in Phase I clinical trials
Insurance and compensation in the event of injury in Phase I clinical trials Guidance developed by the Association for the British Pharmaceutical Industry, the BioIndustry Association and the Clinical
More informationCNE Disclosures. To change this title, go to Notes Master
CNE Disclosures Successful Completion: Participants must complete an evaluation form to receive a certificate of completion Contact Hours: 1 contact hour is available to those who meet the successful completion
More informationStandard Operating Procedures (SOP) Research and Development Office
Standard Operating Procedures (SOP) Research and Development Office Title of SOP: Undertaking Risk Assessment of a Research and Development Project SOP Number: 33 Version Number: 1.0 Supercedes: N/A Effective
More informationICH Topic E 6 Guideline for Good Clinical Practice NOTE FOR GUIDANCE ON GOOD CLINICAL PRACTICE (CPMP/ICH/135/95) *
The European Agency for the Evaluation of Medicinal Products Human Medicines Evaluation Unit ICH Topic E 6 Guideline for Good Clinical Practice Step 5, Consolidated Guideline 1.5.96 NOTE FOR GUIDANCE ON
More informationSOP Number: SOP-QA-20 Version No: 1. Author: Date: 1-9-15 (Patricia Burns, Research Governance Manager, University of Aberdeen)
Standard Operating Procedure: SOP Number: SOP-QA-20 Version No: 1 Author: Date: 1-9-15 (Patricia Burns, Research Governance Manager, University of Aberdeen) Approved by: Date: 1-9-15 (Professor Julie Brittenden,
More informationClinical trials in haemophilia
Clinical trials in haemophilia Dr. Paul Giangrande Oxford Haemophilia and Thrombosis Centre & Nuffield Department of Clinical Medicine University of Oxford paul.giangrande@ndm.ox.ac.uk Why do clinical
More information2.2 Roles and Responsibilities in the Conduct and Assessment of Clinical Trials
L1 2.2 Roles and Responsibilities in the Conduct and Assessment of Clinical Trials Presentation to APEC Preliminary Workshop on Review of Drug Development in Clinical Trials Celia Lourenco, PhD, Manager,
More informationPHARMACEUTICAL QUALITY SYSTEM Q10
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE PHARMACEUTICAL QUALITY SYSTEM Q10 Current Step
More informationCareers in Biostatistics and Clinical SAS Programming An Overview for the Uninitiated Justina M. Flavin, Independent Consultant, San Diego, CA
PharmaSUG 2014 Paper CP07 Careers in Biostatistics and Clinical SAS Programming An Overview for the Uninitiated Justina M. Flavin, Independent Consultant, San Diego, CA ABSTRACT In the biopharmaceutical
More informationResources Based, Manufacturing and Consumer Goods Industries Chemicals Industry
EUROPEAN COMMISSION Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs Resources Based, Manufacturing and Consumer Goods Industries Chemicals Industry Version March 2015 QUESTIONS
More informationEMA Update Clinical Trials
EMA Update Clinical Trials Fergus Sweeney, Head, Compliance and Inspections, European Medicines Agency 16 October 2012 An agency of the European Union Disclaimer The views presented in this presentation/these
More informationClinical Data Management Overview
The 2 nd Clinical Data Management Training Clinical Data Management Overview Andrew Taylor ( 安 泰 乐 ), M.S. Head of Clinical Data Management August 30, 2010 Learning Objectives Overview of Process Related
More informationGood Clinical Laboratory Practice (GCLP) An international quality system for laboratories which undertake the analysis of samples from clinical trials
Good Clinical Laboratory Practice (GCLP) An international quality system for laboratories which undertake the analysis of samples from clinical trials Vanessa Grant and Tim Stiles VERSION 2 Published by
More informationHealth Canada s GCP Compliance Program. GCP Information Sessions November 2010
Your Health and Safety... Our priority Votre santé et votre Securité notre priorité Health Canada s GCP Compliance Program GCP Information Sessions November 2010 Objective To describe the role that Health
More informationICH Topic E 6 (R1) Guideline for Good Clinical Practice. Step 5 NOTE FOR GUIDANCE ON GOOD CLINICAL PRACTICE (CPMP/ICH/135/95)
European Medicines Agency July 2002 CPMP/ICH/135/95 ICH Topic E 6 (R1) Guideline for Good Clinical Practice Step 5 NOTE FOR GUIDANCE ON GOOD CLINICAL PRACTICE (CPMP/ICH/135/95) TRANSMISSION TO CPMP July
More informationR&D Administration Manager. Research and Development. Research and Development
Document Title: Document Number: Patient Recruitment SOP031 Staff involved in development: Job titles only Document author/owner: Directorate: Department: For use by: RM&G Manager, R&D Administration Manager,
More informationMarie-Claire Rickard, GCP & Governance Manager Rachel Fay, GCP & Governance Manager Elizabeth Clough, R&D Operations Manager
Standard Operating Procedures (SOP) for: Monitoring SOP 28 Version 7.0 Number: Number: Effective Date: 29 th November 2015 Review Date: 6 th January 2017 Author: Reviewer: Reviewer: Authorisation: Name
More informationThe role, duties and responsibilities of clinical trials personnel Monitoring: rules and recommendations
The role, duties and responsibilities of clinical trials personnel Monitoring: rules and recommendations Maria Luisa Paoloni OPBG Clinical & Research Services Monitoring and Responsible of monitoring:
More informationGCP INSPECTORS WORKING GROUP <DRAFT> REFLECTION PAPER ON EXPECTATIONS FOR ELECTRONIC SOURCE DOCUMENTS USED IN CLINICAL TRIALS
European Medicines Agency London, 17 October 2007 Doc. Ref. EMEA/505620/2007 GCP INSPECTORS WORKING GROUP REFLECTION PAPER ON EXPECTATIONS FOR ELECTRONIC SOURCE DOCUMENTS USED IN CLINICAL TRIALS
More informationThe Trans-Tasman Early Warning System. Processes in Australia and New Zealand
The Trans-Tasman Early Warning System Processes in Australia and New Zealand Version 1.0 May 2013 About Medsafe Medsafe is the New Zealand Medicines and Medical Devices Safety Authority and is responsible
More informationGOOD CLINICAL PRACTICE: CONSOLIDATED GUIDELINE
ICH E6 GCP: Consolidated Guideline: Investigator 1/7 Institutional Review Board Services ICH HARMONIZED TRIPARTITE GUIDELINE E6: GOOD CLINICAL PRACTICE: CONSOLIDATED GUIDELINE 4. INVESTIGATOR 4.1 Investigator's
More informationRoles & Responsibilities of the Sponsor
Roles & Responsibilities of the Sponsor Developed by Center for Cancer Research, National Cancer Institute, NIH Endorsed by the CTN SIG Leadership Group Objectives Funding for clinical research comes from
More informationOECD Recommendation on the Governance of Clinical Trials
OECD Recommendation on the Governance of Clinical Trials Marketing authorisation status of the medicinal products Non-authorised medicine Authorised medicine, treatment regimen outside
More informationTHE CLINICAL TRIALS BILL (No. XIX of 2010) Explanatory Memorandum
THE CLINICAL TRIALS BILL (No. XIX of 2010) Explanatory Memorandum 1. The object of this Bill is to provide the legal framework for the conduct of clinical trials for the purpose of discovering or verifying
More informationBetter Skills Better Jobs Better Health. National occupational standards for the practice of public health guide
Better Skills Better Jobs Better Health National occupational standards for the practice of public health guide March 2004 Acknowledgements These national occupational standards describe good practice
More informationRegulatory Considerations for Conducting Clinical Trials In India
Regulatory Considerations for Conducting Clinical Trials In India By Mukesh Kumar, PhD & Surinder Kher, MD In the last few years, there has been increasing interest in the pharmaceutical industry in outsourcing
More informationConduct of clinical Trials Communication of
PrinciPles on Conduct of clinical Trials Communication of clinical Trial results Table of Contents Preamble...1 Commitment to Protecting Research Participants...5 Conduct of Clinical Trials...7 Ensuring
More informationgsop-32-02 - Vendor Assessment SOP page 1 of 10
gsop-32-02 - Vendor Assessment SOP page 1 of 10 Hertfordshire Hospitals R&D Consortium Incorporating West Herts Hospitals NHS Trust and East & North Herts NHS Trust VENDOR ASSESSMENT Research & Development
More informationEMA Clinical Laboratory Guidance - Key points and Clarifications PAUL STEWART
EMA Clinical Laboratory Guidance - Key points and Clarifications PAUL STEWART Framework Labs generate data that are used to make decisions on the safety and efficacy of medicinal products; consequently,
More informationQUALIFICATIONS PACK - OCCUPATIONAL STANDARDS FOR LIFE SCIENCES INDUSTRY OCCUPATION: RESEARCH AND DEVELOPMENT REFERENCE ID: LFS/Q0503
h QUALIFICATIONS PACK - OCCUPATIONAL STANDARDS FOR LIFE SCIENCES INDUSTRY Contents OS describe what individuals need to do, know and understand in order to carry out a particular job role or function OS
More informationImporting pharmaceutical products to China
Importing pharmaceutical products to China Imported pharmaceutical products need pre-market approval before entering the Chinese market Imported drugs for human use are required to obtain pre-market approval
More informationGuidance for Industry E6 Good Clinical Practice: Consolidated Guidance
Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance ICH April 1996 Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance Additional copies are available from: the Drug
More informationCLINICAL RESEARCH GENERIC TASK DESCRIPTIONS
Purpose Purpose Purpose Primary responsibility for implementation, coordination, evaluation, communication and/or management of research studies. May involve more than one study or multiple sites within
More informationTHE BIOTECH & PHARMACEUTICAL INDUSTRY
THE BIOTECH & PHARMACEUTICAL INDUSTRY ESSENTIAL CAREERS INFORMATION CALUM LECKIE KATIE BISARO CAREERS CONSULTANTS What we will cover Sector overview Types of role Graduate recruitment trends and issues
More information