EMEA is establishing a project is for candidate countries..
The aim of the project is to build contacts and relationships between the EMEA and the Candidate and Potential Candidate Countries, for future collaboration in the EMEA’s activities and its relationships with Member States.
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Thalidomide apology from England after 50 years..
Mr O'Brien, the MP for North Warwickshire said that ¨The Government wishes to express its sincere regret and deep sympathy for the injury and suffering endured by all those affected when expectant mothers took the drug thalidomide between 1958 and 1961.¨ About 2,000 babies were born with deformities as a result of the drug.
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UK response to European Commission review of the Clinical Trials Directive..
The views of MHRA have now been incorporated into the UK’s overall response to the EU's revision process of Clinical Trials Directive 2001/20/EC, and published on the website.
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CTM December: Medical Publication Trends by Geographic Region..
In the December issue of CTM, medical publications were analysed depending on Index Medicus (PubMed) database. There is a considerable increase in the number of publications from Asia and Emerging countries. Performance of Turkey is outstanding in both total number of publications, number of articles published in high ranked journals and number of evidence based articles. Go to the news to reach the full-text article.
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New web addresses..
You can now reach our webpages from these addresses: www.cresearchtr.org or www.researchtr.org Please bookmark.
Last issues of CTM..
The 10-11th issues of CTM are devoted to the CTM congress.
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Merry christmas and a happy new year..
Clinical Research Association wishes a merry christmas and a happy new year...
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International Compilation of Human Research Protections..
The International Compilation of Human Research Protections is the standard reference for researchers, regulators, and IRBs/ethics committee members involved in human subjects research around the world.
The Compilation lists the laws, regulations, and guidelines for human subjects research in 94 countries, and from a number of international and regional organizations. The standards are organized into 6 categories:
General
Drugs
Privacy/Data Protection
Human Biological Materials
Genetic
Embryos, Stem Cells, and Cloning
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EORTC course on statistics for non-statisticians..
EORTC is helding the next EORTC course "Clinical Trial Statistics for Non Statisticians", in Brussels, Belgium, on 15-18 June 2010.
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"Towards A Better Future for Pharmacovigilance in Clinical Trials” by EORTC and ECRIN..
EORTC and ECRIN is organizing a Multidisciplinary Workshop on "Towards A Better Future for Pharmacovigilance in Clinical Trials” on behalf of the Road Map Initiative for Clinical Research in Europe.
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FDA Issues Final Guidance on Investigator Responsibilities
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FDA has issued final guidance on "Investigator Responsibilities - Protecting the Rights, Safety, and Welfare of Study Subjects."
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Drug ads are troubling search engines..
Major USA search engines are pressed to stop advertisings from overseas.
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CTM new issue..
The August issue deals with Oncology trials. Oncology accounts for 20.8% of all industry sponsored trials and 20.9% of all sites. Non-industry sponsored oncology trials account for 40.1%. Another manuscript shows that there are 4 Ethical Committes in Turkey approved by USA Office of Human Research Protections.
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FDA Expands Access to Investigational Drugs..
FDA has had rules in 1987 that have allowed patients to have access to investigational drugs. On August 12, 2009, FDA announced changes to the rules to make them broader and clearer for the patient and the treating physician.
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The European Medicines Agency and the FDA have agreed to launch a joint initiative to collaborate on international Good Clinical Practice (GCP) inspection activities..
The initiative comes under the scope of the confidentiality arrangements between the European Commission, the European Medicines Agency and the US FDA. The objectives of the initiative include the sharing of information on inspection planning, policy and outcomes and the conduct of collaborative inspections.
This initiative is an important contribution to ensuring the protection of clinical-trial subjects in the context of the increasing globalisation of clinical research. The European Medicines Agency and the FDA will start their new initiative with an 18-month pilot phase on 1 September 2009.
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MoH approved the Central Clinical Trials Advisory Board and new Ethical Committees...
After the new GCP regulation, the MoH approved the Central Clinical Trials Advisory Board and 7 Clinical Research Ethical Committees.
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Researchers demand more harmonization of European rules for approving clinical studies (from Nature)..
Despite efforts to harmonize the way European countries approve clinical trials, a researcher may see their proposed study rejected in one nation but approved in another. The article in Nature underlines this topic.
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New issue of Clinical Trial Magnifier..
This Issue contains "Industry Trials in BRIC Countries - Brasil, Russia, India and China".
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Clinical trials in Turkiye..
The analysis of clinical tirals conducted in Turkey according to clinicaltrials.gov is updated..
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USA priorities in Comparative-Effectiveness Research
Directed by Congress to develop a list of priorities for the Department of Health and Human Services (DHHS) ended up in a list of priorities of comparative-effectiveness research (CER).
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New documents are on our webpage..
Guidance On The Application Format And Documentation To Be Submitted In An Application For An Ethics Committee Opinion On a Clinical Trial
Manufacture Of Investigational Product(s)
Agreement For Transfer Of Biological Material To Be Used In Clinical Researches
Clinical Trial Budget Form
Ethics Committee Evaluation Form Of A Clinical Trial Application
Standard Operating Procedure Of Ethics Committees
Guidance On Insuring Subjects In A Clinical Trial
Guidance On Observational Studies Performed With Drugs
Guideline On The Compassionate Use Program 01.02.2009
Application Form To Import Investigational Products For Clinical Trial Use
Guideline For Good Clinical Practices -2009
Clinical Trial Application Form
Guidance On The Collection, Verification And Presentation Of Adverse Reaction Reports Occurring During Clinical Trials
Annual Notification Form To The Ministry And Ethics Committee For A Clinical Trial
Notification Form Of The End Of A Clinical Trial To The Ministry And The Ethics Committee
Headings For Aspects Of A Clinical Trial That Might Require A Substantial Amendment
Notification Form To Obtain Ministry Approval and Opinion of The Ethics Committee For a Substantial Amendment To a Clinical Trial
Application Form Of A Clinical Trial For Specialty Thesis and/or Academic Purposes
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ICREL (Impact on Clinical Research of European Legislation) report has been submitted to the European Commission...
ICREL was a one-year project financed by the European 7th Framework Programme. Under EFGCP’s coordination, ECRIN, EORTC, as well as the Hospital Clínic of Barcelona and the Ethics Committee of the Medical University of Vienna collaborated in this project.
Its aim was to measure and analyse the direct and indirect impact of the Clinical Trials Directive2001/20/EC and related legislations in the EU on all categories of clinical research.
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Clinical Research Discussion Forum..
You can start using the Clinical Research Discussion forum from our webpage...
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CTM 2009 Congress..
Clinical Trial Magnifier 2009 Congress will be held in Hong Kong on November 13-15, 2009.
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Scientific fraud disclosed..
A leading anesthesiology researcher has been accused of falsifying data and other fraud in potentially dozens of published studies.
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FDA inspections from the last issue of Clinical Trials Magnifier..
The title of the manuscript is "US FDA Site Inspection Findings, 1997-2008, Fail to Justify Globalization Concerns"
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MoH initiated the accreditation of CRO's..
After the new GCP regulation came into effect, Ministry of Health begin accreditation of CRO's. MENE RESEARCH is the first CRO who gets an accreditation.
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A survey on investigator-initiated studies
A survey on investigator-initiated studies is being conducted by Clinical Trials Magnifier Journal. To respond to the survey, please go to the news.
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New ethical committees..
The cities where the new ethical committees will be organized according to the new GCP regulation is listed.
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New issue of Clinical Trial Magnifier..
This issue includes articles on Validity of Clinical Trials in emerging countries, a survey on Phase I trials and US FDA New Drug Approval Trends, 1999-2008.
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FDA warned against Ranbaxy laboratories..
FDA reported that India based Ranbaxy laboratories has provided falsified data for the approval of drugs.
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Updated web site of General Directory of Pharmacy and Pharmaceuticals is online..
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The new interface deserves attention for the functional design and easy access to documents. The English version will be available soon.
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Turkish Clinical Research Organization Association..
Turkish Clinical Research Organization Association is founded in January. The Society aims to collobrate between its members, represent them in various platforms, and improve the efficiency and quality in Clinical Research. Education is also a main priority of the organization.
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FDA issued a warning for Metoclopramide..
A commonly used drug, metoclopramide requires a box warning for tardive dyskinesa.
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FDA approvals won't save companies..
The US Supreme Court ruled that drug makers can be held liable for harm caused by their medicines, even if the drugs already carry federally approved warning labels.
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