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The Clinical Trials Toolkit provides practical advice to researchers in designing and conducting publicly funded clinical trials in the UK. Through the use of an interactive routemap, this site provides information on best practice and outlines the current legal and practical requirements for conducting clinical trials. Get started with the Routemap. Latest Clinical Trials Toolkit news. Updated guidance on Good Clinical Practice (GCP) training. UK Policy Framework - Health and Social Care. We would welco...

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Home | ct-toolkit.ac.uk Reviews

https://ct-toolkit.ac.uk

The Clinical Trials Toolkit provides practical advice to researchers in designing and conducting publicly funded clinical trials in the UK. Through the use of an interactive routemap, this site provides information on best practice and outlines the current legal and practical requirements for conducting clinical trials. Get started with the Routemap. Latest Clinical Trials Toolkit news. Updated guidance on Good Clinical Practice (GCP) training. UK Policy Framework - Health and Social Care. We would welco...

INTERNAL PAGES

ct-toolkit.ac.uk ct-toolkit.ac.uk
1

Clinical Trials Toolkit | Sitemap

http://www.ct-toolkit.ac.uk/sitemap

Administration of Radioactive Substances Advisory Committee (ARSAC). Advanced Therapy Investigational Medicinal Products (ATIMP). Advanced Therapy Medicinal Products (ATMP). Authorised Health Professional (AHP). Case Report Form (CRF). Clinical Trial Authorisation (CTA). Clinical Trial Certificate (CTC). Clinical Trial Notification Scheme. Clinical Trial of an Investigational Medicinal Product (CTIMP). Clinical Trials Directive (CTD) (also known as EU Clinical Trials Directive (EUCTD). Control Group / Arm.

2

Clinical Trials Toolkit | About this site

http://www.ct-toolkit.ac.uk/about-this-site

The Clinical Trials Toolkit was initially developed and launched in 2004 by the MRC and the Department of Health to help clinical trialists and R&D managers understand the regulations and requirements for conducting trials. As the lead organisation for funding clinical trials, the NIHR. Has now taken over responsibility for the Clinical Trials Toolkit. Health Research Authority (HRA). Medical Research Council (MRC) and other UK Clinical Research Collaboration (UKCRC) partners and stakeholders. The NIHR w...

3

Clinical Trials Toolkit | Glossary

http://www.ct-toolkit.ac.uk/glossary

Administration of Radioactive Substances Advisory Committee (ARSAC). The committee that advises the Health Departments on written applications from practitioners for certificates which will enable them to use specific radioactive medicinal products in diagnosis, therapy or research. An ARSAC research certificate is obtained for all trials which result in radiation exposure to subjects additional to that involved in their routine diagnostic or therapeutic management. A gene therapy medicinal product.

4

Clinical Trials Toolkit | FAQs

http://www.ct-toolkit.ac.uk/faqs

1 What are the UK Regulations? The Medicines for Human Use (Clinical Trials) Regulations 2004. Is the Statutory Instrument that transposed the EU Clinical trials Directive (PDF, 152 KB). Into UK law in May 2004. Each member state will have their own regulations or administrative provisions transposing the Directive into national law. 2 Are all clinical trials covered by the Regulations? The Directive (PDF, 152 KB). And the implementing UK Regulations. For a precise definition.). Not all unlicensed chemic...

5

Clinical Trials Toolkit | Cookie policy

http://www.ct-toolkit.ac.uk/cookie-policy

Cookies are small, text-only strings of data which store information on the hard drive of your local computer or mobile device when you visit some websites. How long do cookies last? Cookies last for different lengths of time depending on what they are used for. Session cookies are temporary cookies and are only stored until you leave the website or when you close your web browser. Cookies used on the CTT website:. At End Of Session. Cookies used by 3. Parties to provide services to CTT visitors:. Google...

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Other useful information - Bristol, North Somerset and South Gloucestershire

http://www.apcrc.nhs.uk/governance/links.htm

From 31 March 2016, HRA Approval will be used wherever the project involves NHS organisations in England. This means that: Research described by any of IRAS filter question 2 categories (except those for Research Tissue Bank and Research Database ) can apply for HRA Approval if the lead NHS R&D Office is in England. Projects that have previously sought or gained NHS Permission for participating NHS organisations in England, or applied for REC review, will come under HRA Approval. Research Design Service:...

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Glasgow Clinical Research Facility Education Unit - Web Resources

http://www.glasgowcrf-education.org/web-resources.htm

EU Directive-implications and implementation. Wwwnres.npsa.nhs.uk. National Research Ethics Service (NRES). The organisation responsible for co-ordinating ethics committees in the UK. From this site you may obtain the electronic ethics committee application form and guidance on obtaining ethical approval for all NHS related research, including clinical trials subject to the EU Directive. Http:/ www.ct-toolkit.ac.uk/. Http:/ www.emea.europa.eu/. Http:/ eudract.emea.europa.eu/. This is the official site of...

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Links

http://www.cmahpresearch.org/index.php/links

Allied Health Professions Research Network. AHP National Research Network. Patient and Public Involvement. Allied Health Professions Research Network. Association of Clinical Scientists. Association of Medical Research Councils. British Association of Arts Therapists. British Association of Music Therapists. British Association of Prosthetists and Orthotists. British Association of Social Workers. British and Irish Orthoptic Society. British Society of Hearing Aid Audiologists. Data and Tissues Tool Kit.

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First in Man/Clinical Trials | Regulatory Roadmap | Development of Human Medicinal Products | Research Quality Association | RQA

http://www.therqa.com/regulatory-roadmap/first-man-clinical-trials

Become a Member or Upgrade. First in Man/Clinical Trials. Committees, G.E.T and Working Parties. Events Calendar and Booking. RQA 2016 Annual Conference. Definitive Guide to ISO DIS 9001:2014. Advertise with the RQA. QA as a Profession. Regulatory Roadmap for the development of human medicinal Products (Europe focus). Just click on the various stages below to reveal the information. First in man/ clinical trials. Variations to a Licence. First in Man/Clinical Trials. Test Article Safety Reports (GMP).

rds-sc.nihr.ac.uk rds-sc.nihr.ac.uk

Resources « Research Design Service

http://www.rds-sc.nihr.ac.uk/resources-and-links

These pages provide information, tips and information about other resources that can help your research team to plan an effective study. Follow the links on the right to access specialist advice on specific aspects of a study. Please note that Research Design Service South Central does not endorse all or any of the content or opinion expressed in the sites listed below. Get started with our Information Pack for Health and Social Care Researchers. Refining your research idea. Getting your methodology right.

grantsmanship.ncri.org.uk grantsmanship.ncri.org.uk

NCRI Grantsmanship Gateway – Ethical approval

http://grantsmanship.ncri.org.uk/study-set-up/ethical-approval

Involving patients and the public. UK Clinical Research Networks. NCRI Clinical Studies Groups. Survivorship and end of life care. Most funders will require ethics approval for your study before funds can be released, it is therefore important to consider the ethical implications of your research during the study set-up. You will need to incorporate sufficient time for gaining these approvals in the timeline of your research. National Research Ethics Service. ESRC framework for research ethics. The Medic...

clinicaltrialsunit.iop.kcl.ac.uk clinicaltrialsunit.iop.kcl.ac.uk

King’s Clinical Trials Unit | Clinical Trials Glossary

http://clinicaltrialsunit.iop.kcl.ac.uk/page/Glossary.aspx

Kingâ s Clinical Trials Unit. Kingâ s Clinical Trials Unit. Clinical Trials Advisory Sessions. Kingâ s Trials Partnership Events. Trial Manager and Data Manager Network. Adherence means sticking to the treatment you are allocated. For example, if you are asked to take tablets as part of a trial, it’s about taking the right number of tablets at the right time, and, if appropriate, finishing the course. Blinding / double blinding. Blinding means that whoever is receiving or assessing the effects of treatme...

siobhanlimconsulting.co.uk siobhanlimconsulting.co.uk

Useful Links - Business

http://siobhanlimconsulting.co.uk/useful-links/4549565259

Useful Links - Business. Applied Clinical Trials Online. Data and Tissues Toolkit. MHRA - Online GCP Forum. MRC Regulatory Support Centre. UK Research Integrity Office. Vol 10 Clinical Trials. GCP Guideline - ICH E6. Many of the above sites have been specifically developed to assist clinical researchers with the information, guidance and UK Regulations required to undertake a clinical research study. 2015 Siobhan Lim Consulting. Project Management (2 day). You are viewing the text version of this site.

ctu.co.uk ctu.co.uk

King’s Clinical Trials Unit | Clinical Trials Glossary

http://ctu.co.uk/page/Glossary.aspx

Kingâ s Clinical Trials Unit. Kingâ s Clinical Trials Unit. Clinical Trials Advisory Sessions. Kingâ s Trials Partnership Events. Trial Manager and Data Manager Network. Adherence means sticking to the treatment you are allocated. For example, if you are asked to take tablets as part of a trial, it’s about taking the right number of tablets at the right time, and, if appropriate, finishing the course. Blinding / double blinding. Blinding means that whoever is receiving or assessing the effects of treatme...

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The Clinical Trials Toolkit provides practical advice to researchers in designing and conducting publicly funded clinical trials in the UK. Through the use of an interactive routemap, this site provides information on best practice and outlines the current legal and practical requirements for conducting clinical trials. Get started with the Routemap. Latest Clinical Trials Toolkit news. Updated guidance on Good Clinical Practice (GCP) training. UK Policy Framework - Health and Social Care. We would welco...

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