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Google Keyword Rankings for : legislation clinical trials
1
History, Policies, and Laws - ClinicalTrials.gov
https://clinicaltrials.gov/ct2/about-site/history
Overall, the final rule clarifies which clinical trials of FDA-regulated drug products (including biological products) and device products and which pediatric ...
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https://clinicaltrials.gov/ct2/about-site/history
Overall, the final rule clarifies which clinical trials of FDA-regulated drug products (including biological products) and device products and which pediatric ...
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2
Clinical Research Regulation For United States | ClinRegs
https://clinregs.niaid.nih.gov/country/united-states
NIAAA follows and recommends the guidelines for clinical trials involving human subjects developed by the Department of Health and Human Services and the ...
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https://clinregs.niaid.nih.gov/country/united-states
NIAAA follows and recommends the guidelines for clinical trials involving human subjects developed by the Department of Health and Human Services and the ...
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3
Clinical Trials Regulation | European Medicines Agency
https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials/clinical-trials-regulation
The Clinical Trials Regulation harmonises the processes for assessment and supervision of clinical trials throughout the EU. The evaluation, authorisation and ...
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https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials/clinical-trials-regulation
The Clinical Trials Regulation harmonises the processes for assessment and supervision of clinical trials throughout the EU. The evaluation, authorisation and ...
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4
S.2706 - 117th Congress (2021-2022): DIVERSE Trials Act
https://www.congress.gov/bill/117th-congress/senate-bill/2706
This bill requires activities to increase diversity in clinical trials. It also expands reporting by laboratories that test for and diagnose COVID-19 and ...
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https://www.congress.gov/bill/117th-congress/senate-bill/2706
This bill requires activities to increase diversity in clinical trials. It also expands reporting by laboratories that test for and diagnose COVID-19 and ...
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5
Clinical Trials of Investigational Medicinal Products (CTIMPs)
https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/clinical-trials-investigational-medicinal-products-ctimps/
Legislation sets out how drug trials are approved, conducted, monitored and reported.
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https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/clinical-trials-investigational-medicinal-products-ctimps/
Legislation sets out how drug trials are approved, conducted, monitored and reported.
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6
Conducting Clinical Trials in the US and Abroad
https://www.squirepattonboggs.com/-/media/files/insights/publications/2009/10/conducting-clinical-trials-in-the-us-and-abroad-__/files/ssdcentral68696v2draftwhitepaperconductingclinic__/fileattachment/ssdcentral68696v2draftwhitepaperconductingclinic__.pdf
Pharmaceuticals and biologics are regulated under a different set of laws and regulations than apply to medical devices but both are regulated by the FDA. This ...
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https://www.squirepattonboggs.com/-/media/files/insights/publications/2009/10/conducting-clinical-trials-in-the-us-and-abroad-__/files/ssdcentral68696v2draftwhitepaperconductingclinic__/fileattachment/ssdcentral68696v2draftwhitepaperconductingclinic__.pdf
Pharmaceuticals and biologics are regulated under a different set of laws and regulations than apply to medical devices but both are regulated by the FDA. This ...
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7
Clinical trials regulations - UKRI
https://www.ukri.org/about-us/mrc/our-policies-and-standards/research/clinical-research-governance/clinical-trials-regulations/
The regulations are intended to protect the rights, safety and wellbeing of research participants and to simplify and harmonise regulatory ...
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https://www.ukri.org/about-us/mrc/our-policies-and-standards/research/clinical-research-governance/clinical-trials-regulations/
The regulations are intended to protect the rights, safety and wellbeing of research participants and to simplify and harmonise regulatory ...
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8
Eshoo, Kelly, and Fitzpatrick Introduce Bill to Strengthen ...
https://eshoo.house.gov/media/press-releases/eshoo-kelly-and-fitzpatrick-introduce-bill-strengthen-diversity-clinical-trials
The NIH Clinical Trial Diversity Act would establish goals to include underrepresented populations in NIH-funded clinical trials. WASHINGTON, DC ...
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https://eshoo.house.gov/media/press-releases/eshoo-kelly-and-fitzpatrick-introduce-bill-strengthen-diversity-clinical-trials
The NIH Clinical Trial Diversity Act would establish goals to include underrepresented populations in NIH-funded clinical trials. WASHINGTON, DC ...
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9
Legislation Targets High Cost of Clinical Trials
https://www.biopharminternational.com/view/legislation-targets-high-cost-of-clinical-trials
The “Discounted Drugs for Clinical Trials Act” addresses complaints that biopharmaceutical companies make it difficult and expensive for ...
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https://www.biopharminternational.com/view/legislation-targets-high-cost-of-clinical-trials
The “Discounted Drugs for Clinical Trials Act” addresses complaints that biopharmaceutical companies make it difficult and expensive for ...
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10
Clinical Trials Regulation
https://www.esmo.org/policy/esmo-public-policy-webinars/clinical-trials-regulation
The Clinical Trials Regulation, which was adopted in April 2014 and is foreseen to become applicable in January 2022, will introduce major changes to how ...
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https://www.esmo.org/policy/esmo-public-policy-webinars/clinical-trials-regulation
The Clinical Trials Regulation, which was adopted in April 2014 and is foreseen to become applicable in January 2022, will introduce major changes to how ...
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11
New Legislation Expands Access to Clinical Trials
https://www.accc-cancer.org/acccbuzz/blog-post-template/accc-buzz/2021/07/14/new-legislation-expands-access-to-clinical-trials
With the enactment of the Clinical Treatment Act in 2022, the coverage gap for low-income and underserved populations wanting to access clinical ...
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https://www.accc-cancer.org/acccbuzz/blog-post-template/accc-buzz/2021/07/14/new-legislation-expands-access-to-clinical-trials
With the enactment of the Clinical Treatment Act in 2022, the coverage gap for low-income and underserved populations wanting to access clinical ...
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12
The Medicines for Human Use (Clinical Trials) Regulations 2004
https://www.legislation.gov.uk/uksi/2004/1031/contents/made
These Regulations implement Directive 2001/20/EC on the approximation of laws, regulations and administrative provisions of the Member States relating to ...
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https://www.legislation.gov.uk/uksi/2004/1031/contents/made
These Regulations implement Directive 2001/20/EC on the approximation of laws, regulations and administrative provisions of the Member States relating to ...
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13
Modernizing clinical trial regulations: Regulatory innovation ...
https://www.canada.ca/en/health-canada/corporate/about-health-canada/activities-responsibilities/strategies-initiatives/health-products-food-regulatory-modernization/clinical-trial-regulations.html
Modernizing clinical trial regulations will help improve access to novel therapies, while safeguarding patient safety.
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https://www.canada.ca/en/health-canada/corporate/about-health-canada/activities-responsibilities/strategies-initiatives/health-products-food-regulatory-modernization/clinical-trial-regulations.html
Modernizing clinical trial regulations will help improve access to novel therapies, while safeguarding patient safety.
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14
Clinical Trials - EFPIA
https://www.efpia.eu/about-medicines/development-of-medicines/regulations-safety-supply/clinical-trials/
Compliance with Good Manufacturing Practice (GMP) under Commission Directive 2003/94/EC is also required and ensures that the results of clinical trials are ...
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https://www.efpia.eu/about-medicines/development-of-medicines/regulations-safety-supply/clinical-trials/
Compliance with Good Manufacturing Practice (GMP) under Commission Directive 2003/94/EC is also required and ensures that the results of clinical trials are ...
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15
Greater harmonisation of clinical trial regulations would help ...
https://www.oecd.org/coronavirus/policy-responses/greater-harmonisation-of-clinical-trial-regulations-would-help-the-fight-against-covid-19-732e1c5c/
The OECD Recommendation on the Governance of Clinical Trials is a policy instrument adopted in 2012 that defines a framework for better ...
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https://www.oecd.org/coronavirus/policy-responses/greater-harmonisation-of-clinical-trial-regulations-would-help-the-fight-against-covid-19-732e1c5c/
The OECD Recommendation on the Governance of Clinical Trials is a policy instrument adopted in 2012 that defines a framework for better ...
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16
Equity In Access To Clinical Trials In Medicaid
https://leg.colorado.gov/bills/hb20-1232
The clinical trial must be an approved clinical trial, as described in the act, and must be conducted by agencies and organizations specified in the act.
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https://leg.colorado.gov/bills/hb20-1232
The clinical trial must be an approved clinical trial, as described in the act, and must be conducted by agencies and organizations specified in the act.
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17
Clinical trials under US legislation
https://laegemiddelstyrelsen.dk/en/licensing/clinical-trials/gcp-inspection/clinical-trials-under-us-legislation/
Clinical trials submitted to the US Food and Drug Administration (FDA) for marketing approval must comply with the IND regulations found in ...
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https://laegemiddelstyrelsen.dk/en/licensing/clinical-trials/gcp-inspection/clinical-trials-under-us-legislation/
Clinical trials submitted to the US Food and Drug Administration (FDA) for marketing approval must comply with the IND regulations found in ...
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18
New Federal Incentives for Diversity in Clinical Trials | NEJM
https://www.nejm.org/doi/full/10.1056/NEJMp2209043
In June 2022, the U.S. House of Representatives passed legislation intended to increase the diversity of the populations enrolled in ...
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https://www.nejm.org/doi/full/10.1056/NEJMp2209043
In June 2022, the U.S. House of Representatives passed legislation intended to increase the diversity of the populations enrolled in ...
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19
General Law - Part I, Title XXII, Chapter 175, Section 110L
https://malegislature.gov/Laws/GeneralLaws/PartI/TitleXXII/Chapter175/Section110L
Section 110L: Clinical trials; definitions; coverage ... Code of Federal Regulations; (ii) is not disqualified to oversee clinical research by the National ...
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https://malegislature.gov/Laws/GeneralLaws/PartI/TitleXXII/Chapter175/Section110L
Section 110L: Clinical trials; definitions; coverage ... Code of Federal Regulations; (ii) is not disqualified to oversee clinical research by the National ...
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20
Public Consultation on new Clinical Trials Legislation
https://mhrainspectorate.blog.gov.uk/2022/02/01/public-consultation-on-new-clinical-trials-legislation/
› 2022/02/01 › pu...
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https://mhrainspectorate.blog.gov.uk/2022/02/01/public-consultation-on-new-clinical-trials-legislation/
› 2022/02/01 › pu...
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21
Clinical Trial Diversity Mandates Draw Drug Industry Resistance
https://news.bloomberglaw.com/health-law-and-business/clinical-trial-diversity-mandates-draw-drug-industry-resistance
The drug industry trade group wants Congress to back off mandates aimed at improving the diversity of clinical trial participants, ...
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https://news.bloomberglaw.com/health-law-and-business/clinical-trial-diversity-mandates-draw-drug-industry-resistance
The drug industry trade group wants Congress to back off mandates aimed at improving the diversity of clinical trial participants, ...
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22
42 CFR Part 11 -- Clinical Trials Registration and Results ...
https://www.ecfr.gov/current/title-42/chapter-I/subchapter-A/part-11
Clinical trial means a clinical investigation or a clinical study in which human subject(s) are prospectively assigned, according to a protocol, to one or more ...
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https://www.ecfr.gov/current/title-42/chapter-I/subchapter-A/part-11
Clinical trial means a clinical investigation or a clinical study in which human subject(s) are prospectively assigned, according to a protocol, to one or more ...
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23
Eighty-Seven Patient Groups Urge Congress to Pass ...
https://www.fightcancer.org/releases/eighty-seven-patient-groups-urge-congress-pass-legislation-would-improve-clinical-trial
... to improve the diversity of enrollment in clinical trials as part of ... to Pass Legislation That Would Improve Clinical Trial Diversity ...
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https://www.fightcancer.org/releases/eighty-seven-patient-groups-urge-congress-pass-legislation-would-improve-clinical-trial
... to improve the diversity of enrollment in clinical trials as part of ... to Pass Legislation That Would Improve Clinical Trial Diversity ...
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24
Provisions addressing clinical trial diversity should be ...
https://www.kidneyfund.org/article/provisions-addressing-clinical-trial-diversity-should-be-included-must-pass-legislation
Every five years, Congress must reauthorize a law called the Prescription Drug User Fee Act (PDUFA), which allows the Food and Drug ...
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https://www.kidneyfund.org/article/provisions-addressing-clinical-trial-diversity-should-be-included-must-pass-legislation
Every five years, Congress must reauthorize a law called the Prescription Drug User Fee Act (PDUFA), which allows the Food and Drug ...
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25
diversity in clinical trials - AAMC
https://www.aamc.org/media/61241/download
the House legislative package would require clinical trial sponsors to build in specific, measurable enrollment targets as part of their ...
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https://www.aamc.org/media/61241/download
the House legislative package would require clinical trial sponsors to build in specific, measurable enrollment targets as part of their ...
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26
New regulations on clinical trials promote growth of European ...
https://www.bioclever.com/new-regulations-on-clinical-trials-promote-growth-of-european-research-n-15-en
New Legislation on Clinical Trials ... The new legislation intends to simplify administrative procedures while keeping the same safety guarantees regarding study ...
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https://www.bioclever.com/new-regulations-on-clinical-trials-promote-growth-of-european-research-n-15-en
New Legislation on Clinical Trials ... The new legislation intends to simplify administrative procedures while keeping the same safety guarantees regarding study ...
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27
Medicines (Clinical Trials) Regulations 2016
https://sso.agc.gov.sg/SL/MA1975-S335-2016
1. These Regulations are the Medicines (Clinical Trials) Regulations 2016 and come into operation on 1 November 2016.
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https://sso.agc.gov.sg/SL/MA1975-S335-2016
1. These Regulations are the Medicines (Clinical Trials) Regulations 2016 and come into operation on 1 November 2016.
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28
UK Consultation on Proposals for Legislative Changes for ...
https://www.marken.com/regulatory-updates/uk-consultation-on-proposals-for-legislative-changes-for-clinical-trials/
At the present, the Medicines for Human Use (Clinical Trials) Regulations 2004, transpose the requirements of the EU Clinical Trials ...
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https://www.marken.com/regulatory-updates/uk-consultation-on-proposals-for-legislative-changes-for-clinical-trials/
At the present, the Medicines for Human Use (Clinical Trials) Regulations 2004, transpose the requirements of the EU Clinical Trials ...
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29
Clinical Trial Diversity Advances in Regulatory Agenda
https://www.pharmtech.com/view/clinical-trial-diversity-advances-in-regulatory-agenda
The Diverse & Equitable Participation in Clinical Trials (DEPICT) Act further authorizes FDA to require sponsors that fail to meet diversity ...
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https://www.pharmtech.com/view/clinical-trial-diversity-advances-in-regulatory-agenda
The Diverse & Equitable Participation in Clinical Trials (DEPICT) Act further authorizes FDA to require sponsors that fail to meet diversity ...
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30
UK: Public Consultation on new Clinical Trials Legislation and ...
https://www.gmp-compliance.org/gmp-news/uk-public-consultation-on-new-clinical-trials-legislation-and-impact-on-imps
The proposals are to update the current UK legislation that governs CTs, The Medicines for Human Use (Clinical Trials) Regulations (SI ...
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https://www.gmp-compliance.org/gmp-news/uk-public-consultation-on-new-clinical-trials-legislation-and-impact-on-imps
The proposals are to update the current UK legislation that governs CTs, The Medicines for Human Use (Clinical Trials) Regulations (SI ...
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31
International Compilation of Human Research Standards
https://www.hhs.gov/ohrp/sites/default/files/2018-International-Compilation-of-Human-Research-Standards.pdf
Laws, regulations, or guidelines specific to research integrity, clinical ... 2nd Edition, Chapter 11: Clinical Trials ... Health Canada Clinical Trial.
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https://www.hhs.gov/ohrp/sites/default/files/2018-International-Compilation-of-Human-Research-Standards.pdf
Laws, regulations, or guidelines specific to research integrity, clinical ... 2nd Edition, Chapter 11: Clinical Trials ... Health Canada Clinical Trial.
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32
UK Clinical Trials Regulations | Proposed Changes in 2022
https://florencehc.com/learn/blog-posts/what-do-the-proposed-changes-to-uk-clinical-trial-regulations-mean-for-you
Medicaid coverage of clinical trials will improve inclusion: but there's more work to do.
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https://florencehc.com/learn/blog-posts/what-do-the-proposed-changes-to-uk-clinical-trial-regulations-mean-for-you
Medicaid coverage of clinical trials will improve inclusion: but there's more work to do.
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33
WAC 284-43-5420:
https://apps.leg.wa.gov/WAC/default.aspx?cite=284-43-5420
A carrier must not restrict coverage of routine patient costs for enrollees who participate in a clinical trial. "Routine costs" means items and services ...
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https://apps.leg.wa.gov/WAC/default.aspx?cite=284-43-5420
A carrier must not restrict coverage of routine patient costs for enrollees who participate in a clinical trial. "Routine costs" means items and services ...
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34
Good clinical practice for clinical trials - GOV.UK
https://www.gov.uk/guidance/good-clinical-practice-for-clinical-trials
e) Where evidence exists that a number of departures from applicable legislative requirements and/or established GCP guidelines have occurred within a single ...
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https://www.gov.uk/guidance/good-clinical-practice-for-clinical-trials
e) Where evidence exists that a number of departures from applicable legislative requirements and/or established GCP guidelines have occurred within a single ...
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35
Clinical trial regulations - BDCT
https://www.bdct.nhs.uk/about-us/research/guidance-for-researchers-and-students/clinical-trial-regulations/
The Medicines for Human Use (Clinical trials) Regulations 2004 ... (MHRA) if drugs or medical devices are involved within that trial. ... MHRA The EU Clinical ...
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https://www.bdct.nhs.uk/about-us/research/guidance-for-researchers-and-students/clinical-trial-regulations/
The Medicines for Human Use (Clinical trials) Regulations 2004 ... (MHRA) if drugs or medical devices are involved within that trial. ... MHRA The EU Clinical ...
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36
Within the scope of the Clinical Trial Regulations?
https://www.ct-toolkit.ac.uk/routemap/within-the-scope-of-the-uk-regulations/index.tm
The European Directive (2001/20/EC) (PDF, 152 KB) no longer applies in the UK. The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations ...
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https://www.ct-toolkit.ac.uk/routemap/within-the-scope-of-the-uk-regulations/index.tm
The European Directive (2001/20/EC) (PDF, 152 KB) no longer applies in the UK. The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations ...
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37
Clinical Trials for Medical Devices and Drugs Relating to ...
https://gazette.gc.ca/rp-pr/p2/2022/2022-03-02/html/sor-dors18-eng.html
(3) The following regulations do not apply to the importation or sale of a COVID-19 drug that is to be tested in a clinical trial or to the ...
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https://gazette.gc.ca/rp-pr/p2/2022/2022-03-02/html/sor-dors18-eng.html
(3) The following regulations do not apply to the importation or sale of a COVID-19 drug that is to be tested in a clinical trial or to the ...
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38
Clinical Trials for Medical Devices and Drugs Relating to ...
https://laws-lois.justice.gc.ca/eng/regulations/SOR-2022-18/page-1.html
(3) The following regulations do not apply to the importation or sale of a COVID-19 drug that is to be tested in a clinical trial or to the ...
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https://laws-lois.justice.gc.ca/eng/regulations/SOR-2022-18/page-1.html
(3) The following regulations do not apply to the importation or sale of a COVID-19 drug that is to be tested in a clinical trial or to the ...
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39
The Unintended Consequences of Clinical Trials Regulations
https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1000131
Trial regulations are damaging noncommercial research and patients. The International Conference on Harmonisation (ICH) version of Good Clinical ...
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https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1000131
Trial regulations are damaging noncommercial research and patients. The International Conference on Harmonisation (ICH) version of Good Clinical ...
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40
Regulations of Clinical Trials
https://www.australianclinicaltrials.gov.au/_files/elearn/module-1/05-regulations-of-clinical-trials.html
Responsibility for the proper conduct of clinical trials is a shared responsibility. · Understanding your role to ensure that your trial, or trial run at your ...
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https://www.australianclinicaltrials.gov.au/_files/elearn/module-1/05-regulations-of-clinical-trials.html
Responsibility for the proper conduct of clinical trials is a shared responsibility. · Understanding your role to ensure that your trial, or trial run at your ...
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41
Clinical Trials - HPRA
http://www.hpra.ie/homepage/medicines/regulatory-information/clinical-trials
New clinical trials legislation was implemented in Europe on 31 January 2022. The Clinical Trials Directive is being replaced by the Clinical Trials ...
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http://www.hpra.ie/homepage/medicines/regulatory-information/clinical-trials
New clinical trials legislation was implemented in Europe on 31 January 2022. The Clinical Trials Directive is being replaced by the Clinical Trials ...
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42
Update on the Clinical Trial Regulation – national ... - Arthur Cox
https://www.arthurcox.com/knowledge/update-on-the-clinical-trial-regulation-national-implementing-legislation-introduced/
Implementing Legislation. The European Union (Clinical Trials on Medicinal Products for Human Use) (Principal) Regulations 2022 (the “Principal ...
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https://www.arthurcox.com/knowledge/update-on-the-clinical-trial-regulation-national-implementing-legislation-introduced/
Implementing Legislation. The European Union (Clinical Trials on Medicinal Products for Human Use) (Principal) Regulations 2022 (the “Principal ...
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43
Understanding the EU Clinical Trials Regulations Updates
https://www.advarra.com/blog/understanding-the-eu-clinical-trials-regulations-updates/
The updated European Union (EU) pharmaceutical legislation for the Clinical Trials Regulation (CTR) entered into application on January 1, ...
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https://www.advarra.com/blog/understanding-the-eu-clinical-trials-regulations-updates/
The updated European Union (EU) pharmaceutical legislation for the Clinical Trials Regulation (CTR) entered into application on January 1, ...
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44
MHRA Launches UK Clinical Trial Regulation Consultation
https://www.mwe.com/insights/mhra-launches-uk-clinical-trial-regulation-consultation/
The current UK clinical trial regulations are derived from the 2001 EU Directive. As a consequence of Brexit, the United Kingdom has not ...
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https://www.mwe.com/insights/mhra-launches-uk-clinical-trial-regulation-consultation/
The current UK clinical trial regulations are derived from the 2001 EU Directive. As a consequence of Brexit, the United Kingdom has not ...
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45
Clinical trials | Therapeutic Goods Administration (TGA)
https://www.tga.gov.au/clinical-trials
The clinical trial sponsor must also comply with the requirements of the therapeutic goods legislation as well as any other Commonwealth or ...
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https://www.tga.gov.au/clinical-trials
The clinical trial sponsor must also comply with the requirements of the therapeutic goods legislation as well as any other Commonwealth or ...
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46
The international quality requirements for the conduct of ...
https://www.annalsofoncology.org/article/S0923-7534(19)46064-X/fulltext
The current regulations for conducting clinical trials with pharmaceutical compounds in the USA can be found in the Code of Federal Regulations (CFR).
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https://www.annalsofoncology.org/article/S0923-7534(19)46064-X/fulltext
The current regulations for conducting clinical trials with pharmaceutical compounds in the USA can be found in the Code of Federal Regulations (CFR).
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47
S.I. No. 190/2004 - European Communities (Clinical Trials on ...
https://www.irishstatutebook.ie/eli/2004/si/190/made/en/print
1. These Regulations may be cited as the European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations 2004. Commencement.
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https://www.irishstatutebook.ie/eli/2004/si/190/made/en/print
1. These Regulations may be cited as the European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations 2004. Commencement.
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48
Hematologic Malignancy and Oncologic ... - Regulations.gov
https://www.regulations.gov/docket/FDA-2018-D-3092
Hematologic Malignancy and Oncologic Disease: Considerations for Use of Placebos and Blinding in Randomized Controlled Clinical Trials for Drug Product ...
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https://www.regulations.gov/docket/FDA-2018-D-3092
Hematologic Malignancy and Oncologic Disease: Considerations for Use of Placebos and Blinding in Randomized Controlled Clinical Trials for Drug Product ...
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49
Guideline on the Regulation of Therapeutic Products in New ...
https://medsafe.govt.nz/regulatory/Guideline/GRTPNZ/Part11.pdf
Part 11 of the regulatory guideline. 1.1 Legislation relating to clinical trials. The following legislation should be read in conjunction with this part of ...
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https://medsafe.govt.nz/regulatory/Guideline/GRTPNZ/Part11.pdf
Part 11 of the regulatory guideline. 1.1 Legislation relating to clinical trials. The following legislation should be read in conjunction with this part of ...
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50
Clinical Trial and Results Registries Act
https://alec.org/model-policy/clinical-trial-and-results-registries-act/
Section 2. Summary. This bill establishes an agreement for {insert state} to adopt and abide to federal legislation for Clinical Trial and Results Registries ( ...
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https://alec.org/model-policy/clinical-trial-and-results-registries-act/
Section 2. Summary. This bill establishes an agreement for {insert state} to adopt and abide to federal legislation for Clinical Trial and Results Registries ( ...
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51
US Legislation and Regulation – ACRO
https://www.acrohealth.org/us-legislation-and-regulation/
Half of all clinical trials take place in the United States. That's why ACRO works with US legislators and regulators to ensure a positive regulatory and ...
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https://www.acrohealth.org/us-legislation-and-regulation/
Half of all clinical trials take place in the United States. That's why ACRO works with US legislators and regulators to ensure a positive regulatory and ...
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52
What is the DEPICT Act? - Society for Clinical Research Sites
https://myscrs.org/resources/depict-act/
This legislation aims to increase diversity in clinical trials by requiring enhanced data reporting on clinical trial participant ...
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https://myscrs.org/resources/depict-act/
This legislation aims to increase diversity in clinical trials by requiring enhanced data reporting on clinical trial participant ...
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53
Bill Status for HB4314 - Illinois General Assembly
https://www.ilga.gov/legislation/BillStatus.asp?DocNum=4314&GAID=15&DocTypeID=HB&LegId=123423&SessionID=108&GA=101
Defines "approved clinical trial" to mean a phase I, II, III, or IV clinical trial involving the prevention, detection, or treatment of cancer or any other life ...
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https://www.ilga.gov/legislation/BillStatus.asp?DocNum=4314&GAID=15&DocTypeID=HB&LegId=123423&SessionID=108&GA=101
Defines "approved clinical trial" to mean a phase I, II, III, or IV clinical trial involving the prevention, detection, or treatment of cancer or any other life ...
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54
FDA Regulations - USC. OPRS
https://oprs.usc.edu/policies/fda-regulations/
FDA Regulations. The Food and Drug ... Regulations pertaining to human subjects research include: ... Clinical Trials and Investigational Device Exemption ...
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https://oprs.usc.edu/policies/fda-regulations/
FDA Regulations. The Food and Drug ... Regulations pertaining to human subjects research include: ... Clinical Trials and Investigational Device Exemption ...
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55
Regulations and requirements for clinical trials - Staff
https://staff.ki.se/regulations-and-requirements-for-clinical-trials-and-clinical-studies
The regulations and requirements for clinical trials differ than those for clinical studies. It is important to understand the distinct legal and ethical ...
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https://staff.ki.se/regulations-and-requirements-for-clinical-trials-and-clinical-studies
The regulations and requirements for clinical trials differ than those for clinical studies. It is important to understand the distinct legal and ethical ...
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56
First in Man/Clinical Trials | Regulatory Roadmap - RQA
https://www.therqa.com/good-practices/regulatory-roadmap/first-man-clinical-trials/
Marketed products may fall under the same regulations if the product is used as part of an interventional trial. (The product must meet the definition of an IMP) ...
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https://www.therqa.com/good-practices/regulatory-roadmap/first-man-clinical-trials/
Marketed products may fall under the same regulations if the product is used as part of an interventional trial. (The product must meet the definition of an IMP) ...
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57
Rules for clinical trials | Medicines
https://english.igj.nl/medicines/clinical-trials-gcp/rules-for-clinical-trials
Clinical trials involving human subjects must be safe and the welfare of the subjects must be protected. The results from clinical research must also be ...
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https://english.igj.nl/medicines/clinical-trials-gcp/rules-for-clinical-trials
Clinical trials involving human subjects must be safe and the welfare of the subjects must be protected. The results from clinical research must also be ...
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58
Contents - GOV.UK
https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1046680/Clinical_trial_consultation_proposals_final.pdf
CONSULTATION ON PROPOSALS FOR LEGISLATIVE CHANGES. FOR CLINICAL TRIALS. Better regulation, for better trials, for better health. Contents.
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https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1046680/Clinical_trial_consultation_proposals_final.pdf
CONSULTATION ON PROPOSALS FOR LEGISLATIVE CHANGES. FOR CLINICAL TRIALS. Better regulation, for better trials, for better health. Contents.
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59
Local Clinical Trial Legislation in the USA - eLearning - ECCRT
https://eccrt.com/local-clinical-trial-legislation-in-the-usa/
Do you need a clear and hands-on understanding and be up to date with the most current national regulatory legislation for Clinical Trials with ...
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https://eccrt.com/local-clinical-trial-legislation-in-the-usa/
Do you need a clear and hands-on understanding and be up to date with the most current national regulatory legislation for Clinical Trials with ...
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60
A(nother) New Start for Trial Regulations in Europe?
https://www.appliedclinicaltrialsonline.com/view/a-nother-new-start-for-trial-regulations-in-europe-
“The beginning of an exciting new phase for clinical research in Europe” is how the European pharmaceutical industry has greeted the latest ...
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https://www.appliedclinicaltrialsonline.com/view/a-nother-new-start-for-trial-regulations-in-europe-
“The beginning of an exciting new phase for clinical research in Europe” is how the European pharmaceutical industry has greeted the latest ...
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61
Regulations for clinical trials of medical devices - BAG
https://www.bag.admin.ch/bag/en/home/medizin-und-forschung/forschung-am-menschen/regelungen-medizinprodukte.html
› regelungen-medizinprodukte
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https://www.bag.admin.ch/bag/en/home/medizin-und-forschung/forschung-am-menschen/regelungen-medizinprodukte.html
› regelungen-medizinprodukte
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62
LEĠIŻLAZZJONI MALTA - legislation.mt
https://legislation.mt/eli/sl/458.43/eng
Tip: Subsidiary Legislation. Short Title: Clinical Trials Regulations. Titolu: Clinical Trials Regulations. Link tal-ELI: eli/sl/458.43.
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https://legislation.mt/eli/sl/458.43/eng
Tip: Subsidiary Legislation. Short Title: Clinical Trials Regulations. Titolu: Clinical Trials Regulations. Link tal-ELI: eli/sl/458.43.
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63
Legislative Changes - Rethinking Clinical Trials
https://rethinkingclinicaltrials.org/chapters/dissemination/dissemination-implementation-top/legislative-changes/
Legislation can be an important way both to generate interest in a particular trial and to sustain its impacts. At the onset of the Strategies and ...
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https://rethinkingclinicaltrials.org/chapters/dissemination/dissemination-implementation-top/legislative-changes/
Legislation can be an important way both to generate interest in a particular trial and to sustain its impacts. At the onset of the Strategies and ...
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64
United Kingdom: Legislative changes for clinical trials on the ...
https://www.lexology.com/library/detail.aspx?g=e2d22368-f844-419c-a63a-1bee6c2f7a64
The proposals will result in updates to the current UK legislation governing clinical trials, the Medicines for Human Use (Clinical Trials) ...
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https://www.lexology.com/library/detail.aspx?g=e2d22368-f844-419c-a63a-1bee6c2f7a64
The proposals will result in updates to the current UK legislation governing clinical trials, the Medicines for Human Use (Clinical Trials) ...
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65
Key documents & regulations - Research Support
https://researchsupport.admin.ox.ac.uk/clinical-trials-research-governance/governance/documents
Clinical trials should be scientifically sound, and described in a clear, detailed protocol. A trial should be conducted in compliance with the protocol that ...
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https://researchsupport.admin.ox.ac.uk/clinical-trials-research-governance/governance/documents
Clinical trials should be scientifically sound, and described in a clear, detailed protocol. A trial should be conducted in compliance with the protocol that ...
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66
2012 Regulations - Clinical Trials - CT.gov
https://portal.ct.gov/-/media/CID/2012RegulationsClinicalTrialspdf.pdf
Clinical Trials. Concerning. [Cancer] Clinical Trials. SECTION I. Section 38a-504a-3 of the Regulations of Connecticut State Agencies is amended to read as ...
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https://portal.ct.gov/-/media/CID/2012RegulationsClinicalTrialspdf.pdf
Clinical Trials. Concerning. [Cancer] Clinical Trials. SECTION I. Section 38a-504a-3 of the Regulations of Connecticut State Agencies is amended to read as ...
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67
Fewer than half of US clinical trials have complied with the law ...
https://www.healthcarefinancenews.com/news/fewer-half-us-clinical-trials-have-complied-law-reporting-results-despite-new-regulations
The first trials covered by the Final Rule were due to report in January 2018. To investigate the extent of compliance with these new reporting ...
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https://www.healthcarefinancenews.com/news/fewer-half-us-clinical-trials-have-complied-law-reporting-results-despite-new-regulations
The first trials covered by the Final Rule were due to report in January 2018. To investigate the extent of compliance with these new reporting ...
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68
Clinical trials: UK proposes risk-based regulation
https://www.pinsentmasons.com/out-law/news/clinical-trials-uk-proposes-risk-based-regulation
Under current rules, clinical trials cannot go ahead in the UK until they have been scrutinised by a Research Ethics Committee (REC) and ...
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https://www.pinsentmasons.com/out-law/news/clinical-trials-uk-proposes-risk-based-regulation
Under current rules, clinical trials cannot go ahead in the UK until they have been scrutinised by a Research Ethics Committee (REC) and ...
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69
3. History of Clinical Research Legislation in Europe
https://learning.eupati.eu/mod/book/view.php?id=339&chapterid=251
Before a trial is initiated, foreseeable risks and inconveniences should be weighed against anticipated benefit for the individual trial subject and society. A ...
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https://learning.eupati.eu/mod/book/view.php?id=339&chapterid=251
Before a trial is initiated, foreseeable risks and inconveniences should be weighed against anticipated benefit for the individual trial subject and society. A ...
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70
Italy: New Legislation on Clinical Trials of Medicines Takes ...
https://www.loc.gov/item/global-legal-monitor/2019-08-12/italy-new-legislation-on-clinical-trials-of-medicines-takes-effect/
To facilitate not-for-profit clinical trials of medicines for human use, the new law contains provisions authorizing a broader transfer of the ...
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https://www.loc.gov/item/global-legal-monitor/2019-08-12/italy-new-legislation-on-clinical-trials-of-medicines-takes-effect/
To facilitate not-for-profit clinical trials of medicines for human use, the new law contains provisions authorizing a broader transfer of the ...
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71
EA Legislation: 21st Century Cures and Clinical Trials ...
https://navigator.reaganudall.org/resources/ea-legislation-21st-century-cures-and-clinical-trials-registration
Submitting a request for single-patient expanded access requires the involvement of physicians, patients, the Food and Drug Administration (FDA), ...
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https://navigator.reaganudall.org/resources/ea-legislation-21st-century-cures-and-clinical-trials-registration
Submitting a request for single-patient expanded access requires the involvement of physicians, patients, the Food and Drug Administration (FDA), ...
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72
Clinical trials specific legislation – NAMMDR - ANMDMR
https://www.anm.ro/en/medicamente-de-uz-uman/studii-clinice/legislatie-specifica-pentru-studii-clinice/
Clinical trials specific legislation ... Information in this section is only available in Romanian. For the Romanian version, please click here. Agency. > ...
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https://www.anm.ro/en/medicamente-de-uz-uman/studii-clinice/legislatie-specifica-pentru-studii-clinice/
Clinical trials specific legislation ... Information in this section is only available in Romanian. For the Romanian version, please click here. Agency. > ...
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73
Reforms of EU Clinical Trial Regulations Bring Cautious ...
https://www.labiotech.eu/trends-news/eu-regulation-clinical-trial/
The EU's clinical trial regulations received a major overhaul at the end of January 2022 to make trials easier to run across EU member ...
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https://www.labiotech.eu/trends-news/eu-regulation-clinical-trial/
The EU's clinical trial regulations received a major overhaul at the end of January 2022 to make trials easier to run across EU member ...
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74
Menendez, Scott Introduce DIVERSE Trials Act
https://www.menendez.senate.gov/newsroom/press/menendez-scott-introduce-diverse-trials-act
That is why I am introducing the DIVERSE Trials Act, which will increase diversity in clinical trial participation through outreach to ...
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https://www.menendez.senate.gov/newsroom/press/menendez-scott-introduce-diverse-trials-act
That is why I am introducing the DIVERSE Trials Act, which will increase diversity in clinical trial participation through outreach to ...
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75
Title 35 - PA General Assembly
https://www.legis.state.pa.us/cfdocs/legis/LI/consCheck.cfm?txtType=HTM&ttl=35&div=0&chpt=54
Sec. 5401. Scope of chapter. 5402. Legislative findings and intent. 5403. Definitions. 5404. Improving access to cancer clinical trials.
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https://www.legis.state.pa.us/cfdocs/legis/LI/consCheck.cfm?txtType=HTM&ttl=35&div=0&chpt=54
Sec. 5401. Scope of chapter. 5402. Legislative findings and intent. 5403. Definitions. 5404. Improving access to cancer clinical trials.
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76
UK—legislative changes for clinical trials on the horizon
https://insightplus.bakermckenzie.com/bm/attachment_dw.action?attkey=FRbANEucS95NMLRN47z%2BeeOgEFCt8EGQJsWJiCH2WAUuQVQjpl3o%2BbvtxHojCo%2B8&nav=FRbANEucS95NMLRN47z%2BeeOgEFCt8EGQbuwypnpZjc4%3D&attdocparam=pB7HEsg%2FZ312Bk8OIuOIH1c%2BY4beLEAeNMs27YiL%2Bpw%3D&fromContentView=1
proposals will result in updates to the current UK legislation governing clinical trials, the Medicines for Human Use (Clinical Trials) Regulations 2004, ...
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https://insightplus.bakermckenzie.com/bm/attachment_dw.action?attkey=FRbANEucS95NMLRN47z%2BeeOgEFCt8EGQJsWJiCH2WAUuQVQjpl3o%2BbvtxHojCo%2B8&nav=FRbANEucS95NMLRN47z%2BeeOgEFCt8EGQbuwypnpZjc4%3D&attdocparam=pB7HEsg%2FZ312Bk8OIuOIH1c%2BY4beLEAeNMs27YiL%2Bpw%3D&fromContentView=1
proposals will result in updates to the current UK legislation governing clinical trials, the Medicines for Human Use (Clinical Trials) Regulations 2004, ...
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77
US government cracks down on clinical-trials reporting - Nature
https://www.nature.com/articles/nature.2014.16390
The regulations are intended to close a loophole in a 2007 law known as the FDA Amendments Act (FDAAA), which requires sponsors of FDA-approved ...
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https://www.nature.com/articles/nature.2014.16390
The regulations are intended to close a loophole in a 2007 law known as the FDA Amendments Act (FDAAA), which requires sponsors of FDA-approved ...
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78
The New European Union Regulation for Clinical Trials - ACRP
https://acrpnet.org/2017/02/01/the-new-european-union-regulation-for-clinical-trials/
Clinical trials can be defined as investigations made in humans to discover or verify the positive and/or negative effects (effectiveness ...
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https://acrpnet.org/2017/02/01/the-new-european-union-regulation-for-clinical-trials/
Clinical trials can be defined as investigations made in humans to discover or verify the positive and/or negative effects (effectiveness ...
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79
Compliance with legal requirement to report clinical trial ...
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(19)33220-9/fulltext
ACT=applicable clinical trial. As per FDAAA legislation, each trial was considered due to report results if more than 1 year had passed since ...
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https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(19)33220-9/fulltext
ACT=applicable clinical trial. As per FDAAA legislation, each trial was considered due to report results if more than 1 year had passed since ...
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80
Euro Roundup: MHRA seeks feedback on proposals for the ...
https://www.raps.org/news-and-articles/news-articles/2022/1/euro-roundup-mhra-seeks-feedback-on-proposals-for
The Medicines and Healthcare products Regulatory Agency (MHRA) is holding a consultation into the future of clinical trial legislation in ...
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https://www.raps.org/news-and-articles/news-articles/2022/1/euro-roundup-mhra-seeks-feedback-on-proposals-for
The Medicines and Healthcare products Regulatory Agency (MHRA) is holding a consultation into the future of clinical trial legislation in ...
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81
Health Canada to modernise its clinical trial regulations
https://www.europeanpharmaceuticalreview.com/news/156664/health-canada-to-modernise-its-clinical-trial-regulations/
Health Canada has proposed a regulatory framework for clinical trials that will support and streamline drug and medical device development.
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https://www.europeanpharmaceuticalreview.com/news/156664/health-canada-to-modernise-its-clinical-trial-regulations/
Health Canada has proposed a regulatory framework for clinical trials that will support and streamline drug and medical device development.
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82
Food and Drug Administration Clinical Trial Requirements ...
https://www.federalregister.gov/documents/2017/09/25/2017-20375/food-and-drug-administration-clinical-trial-requirements-regulations-compliance-and-good-clinical
Individual FDA representatives will discuss the informed consent process and informed consent documents; regulations relating to drugs, devices, ...
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https://www.federalregister.gov/documents/2017/09/25/2017-20375/food-and-drug-administration-clinical-trial-requirements-regulations-compliance-and-good-clinical
Individual FDA representatives will discuss the informed consent process and informed consent documents; regulations relating to drugs, devices, ...
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83
Clinical Trials in India: History, Current Regulations, and ...
https://www.emich.edu/chhs/health-sciences/programs/clinical-research-administration/documents/research/clinical-trials-in-india.pdf
This paper summarizes the history of clinical trial regulations in India, including why the Supreme Court put a halt on clinical trials, recent ...
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https://www.emich.edu/chhs/health-sciences/programs/clinical-research-administration/documents/research/clinical-trials-in-india.pdf
This paper summarizes the history of clinical trial regulations in India, including why the Supreme Court put a halt on clinical trials, recent ...
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84
Improving Access to Clinical Trials Act Passes U.S. House
https://www.cff.org/node/1156
This legislation enables patients with rare diseases to participate in clinical trials without losing eligibility for public health care ...
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https://www.cff.org/node/1156
This legislation enables patients with rare diseases to participate in clinical trials without losing eligibility for public health care ...
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85
How are clinical trials regulated? - St Pancras Clinical Research
https://www.stpancrasclinicalresearch.com/how-are-clinical-trials-regulated/
How are clinical trials regulated? ... Once researchers have proven a new treatment to have a strong chance of being better than what is currently ...
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https://www.stpancrasclinicalresearch.com/how-are-clinical-trials-regulated/
How are clinical trials regulated? ... Once researchers have proven a new treatment to have a strong chance of being better than what is currently ...
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86
Research integrity: clinical trials transparency
https://publications.parliament.uk/pa/cm201719/cmselect/cmsctech/1480/148005.htm
ensuring that details of all clinical trials are recorded in advance in a publicly-accessible registry (i.e. with legislation and rules ...
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https://publications.parliament.uk/pa/cm201719/cmselect/cmsctech/1480/148005.htm
ensuring that details of all clinical trials are recorded in advance in a publicly-accessible registry (i.e. with legislation and rules ...
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87
The Society for Clinical Trials supports United States ...
https://journals.sagepub.com/doi/10.1191/1740774504cn039oa
The official position of the Society for Clinical Trials is to support legislation in the United States and internationally that mandates registration of ...
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https://journals.sagepub.com/doi/10.1191/1740774504cn039oa
The official position of the Society for Clinical Trials is to support legislation in the United States and internationally that mandates registration of ...
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88
National Legislation - Infarmed - RNEC
https://www.rnec.pt/portugal
The conduct of clinical trials on medicines for human use is governed by Law no. 21/2014 of 16 April that implements Directive 2001/20/EC of the European ...
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https://www.rnec.pt/portugal
The conduct of clinical trials on medicines for human use is governed by Law no. 21/2014 of 16 April that implements Directive 2001/20/EC of the European ...
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89
Clinical trials for human medicines - FAMHP
https://www.famhp.be/en/human_use/medicines/medicines/research_development/clinical_trials
What is a clinical trial? A medicine that is available to patients is the result of a long and complex process (14 years on average), ...
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https://www.famhp.be/en/human_use/medicines/medicines/research_development/clinical_trials
What is a clinical trial? A medicine that is available to patients is the result of a long and complex process (14 years on average), ...
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90
The new Regulation on clinical trials in relation to ...
https://ejnmmipharmchem.springeropen.com/articles/10.1186/s41181-019-0055-6
In the EU the legislation related to clinical trials will be ruled by Regulation 536/2014, the so-called “Clinical Trial Regulation”. There are ...
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https://ejnmmipharmchem.springeropen.com/articles/10.1186/s41181-019-0055-6
In the EU the legislation related to clinical trials will be ruled by Regulation 536/2014, the so-called “Clinical Trial Regulation”. There are ...
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91
Conflicts of Interest in Clinical Trial Recruitment & Enrollment
https://law.shu.edu/health-law/upload/health_center_whitepaper_nov2009.pdf
Government regulations providing guidance on investigator compensation should seek to achieve fi- nancial neutrality as between treatment and research. The fair ...
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https://law.shu.edu/health-law/upload/health_center_whitepaper_nov2009.pdf
Government regulations providing guidance on investigator compensation should seek to achieve fi- nancial neutrality as between treatment and research. The fair ...
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92
UK consultation to update clinical trial legislation
https://www.biopharma-reporter.com/Article/2022/01/20/UK-consultation-to-update-clinical-trial-legislation
Proposed legislative changes seek to improve the speed and efficiency of approvals, support innovation, enhance transparency, encourage greater ...
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https://www.biopharma-reporter.com/Article/2022/01/20/UK-consultation-to-update-clinical-trial-legislation
Proposed legislative changes seek to improve the speed and efficiency of approvals, support innovation, enhance transparency, encourage greater ...
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93
Legislation to Encourage Innovation and Improve Oversight
https://www.youtube.com/watch?v=Oiy0aFXyKzU
Energy and Commerce Committee
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https://www.youtube.com/watch?v=Oiy0aFXyKzU
Energy and Commerce Committee
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94
EU Clinical Trial Regulation: what you need to know
https://www.clinicaltrialsarena.com/analysis/eu-clinical-trial-regulation-what-you-need-to-know/
The regulation's aim is to create a landscape that is “favourable to conducting clinical trials in the EU, with the highest standards of safety ...
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https://www.clinicaltrialsarena.com/analysis/eu-clinical-trial-regulation-what-you-need-to-know/
The regulation's aim is to create a landscape that is “favourable to conducting clinical trials in the EU, with the highest standards of safety ...
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95
Legislation on clinical trials approved by Parliament - Fimea
https://www.fimea.fi/web/en/-/legislation-on-clinical-trials-approved-by-parliament
The Parliament of Finland has adopted a new Act on Clinical Trials on 8 October 2021. The Parliament also approved amendments to the Medical ...
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https://www.fimea.fi/web/en/-/legislation-on-clinical-trials-approved-by-parliament
The Parliament of Finland has adopted a new Act on Clinical Trials on 8 October 2021. The Parliament also approved amendments to the Medical ...
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