http://www.appliedclinicaltrialsonline.com/act-resources ORGANIZATIONS Association of the British Pharmaceutical Industry www.abpi.org.uk This site provides information and statistics on the pharmaceutical industry, ABPI publications, as well as education, training, and career resources. Association of Clinical Research Organizations http://www.acrohealth.org The ACRO site highlights the key issues for CROs and also provides market trends. In addition, it also acts as a resource for pharma and biotech sponsors, patients, and patient advocates. Association of Clinical Research Professionals http://www.acrpnet.org Beyond its extensive training and education resources, ACRP is a one-stop source for public policy updates. Also available to its members is an online community, including eForums, a member directory, and a resource library. Biotechnology Industry Organization http://www.bio.org BIO's site provides information regarding national, state, and local issues of industry. Users can also find BIO news, blogs, and podcasts through this site. CDISC, Clinical Data Interchange Standards Consortium http://www.cdisc.org Provides free downloadable CDISC standards, news on the latest initiatives, an active discussion board, links to regulatory documents and published articles, and a CDISC Glossary of clinical research terms, acronyms, and abbreviations. CISCRP, Center for Information Study on Clinical Research Participation www.ciscrp.org Visitors can find a wealth of information and resources—facts, figures, Web sites—and have the chance to connect with patients, caregivers, and families by joining the Clinical Research Volunteers Community. Clinical Trials Transformation Initiative https://www.trialstransformation.org Laying out the background, scope, and principles of this initiative, the site also provides an area for any interested party to submit a project idea, information on becoming a member, as well as a breakdown of the members behind CTTI. Drug Information Association http://www.diahome.org Find out about upcoming DIA events, webinars, training, internships, and certification programs. DIA's online community is for members only, but non-members are still able to access the job bank and view resumes. EFGCP: Impact on Clinical Research of European Legislation http://www.efgcp.be/ICREL/ A report that aims to measure and analyse the direct and indirect impact of the Clinical Trials Directive2001/20/EC and related legislations in the EU. EPEMED: European Personalized Medicine Association http://www.epemed.org/ A not-for-profit organization bringing together global forces in personalized medicine. EUCROF: The European CRO Federation http://www.eucrof.eu/ An orgaization that aims to promote clinical research of high quality in Europe in general and in the European Union in particular. HL7, Health Level 7 http://www.hl7.org Six main categories make up this standards developing organization's site: About HL7, Events, Members Only, Membership, Resources, and Work Groups. Most resources are accesible to nonmembers, including the bookstore. Pharmaceutical Research and Manufacturers of America http://www.phrma.org Visitors can find PDFs on topics like cancer and women's health, instructional videos, helpful links, a database that lists drugs currently in clinical trials or at FDA for review, and reports on medicines in development. Regulatory Affairs Professionals Society http://www.raps.org Visitiors can make use of professional advancement opportunities, pick up a Title 21 CFR Pocket Guide at the bookstore, scan for a new job or employee, check out upcoming meetings, or peruse the available coureses. Society for Clinical Data Management www.scdm.org An educational portal leads to SCDM's upcoming webinars as well as numerous resources for the clinical data manager certification exam, which SCDM offers. The site also features a job postings section. Society of Clinical Research Associates www.socra.org Find upcoming meetings, conferences, and in-person courses. Make use of instructions for submitting articles for the SoCRA Source journal, a classified section for clinical research jobs, and information on certification programs. Society of Quality Assurance www.sqa.org The purpose of this site is to serve the needs of members, and to inform prospective members and the general public about SQA, what opportunities it offers and what its members do. FDA SITES FDA Home Page www.fda.gov Providing information for consumers, industry, and health professionals, this site covers current science and research, regulations and laws, background information about the FDA, new drug approvals, and drug safety information. FDA Electronic Submissions Gateway http://www.fda.gov/esg Enabling the submission of regulatory information for review, this is the FDA's Agency-wide solution for accepting electronic regulatory submissions. FDA–European Union http://www.fda.gov/oia/EC_EMEA.htm This site covers the international activities taking place between the FDA and Euoropean Union's European Agency for the Evaluation of Medicinal Products and European Commisson. FDAAA Implementation Chart http://www.fda.gov/oc/initiatives/advance/fdaaa/implementation_chart.html A chart overviewing the implementation of the FDA Amendments Act of 2007, including the effected section of the Agency, a description of necessary actions, a target date, the actions completed, and an agency contact for each. Current Guidances http://www.fda.gov/opacom/morechoices/industry/guidedc.htm This site provides all guidance documents set out by the FDA, organized by the Agency's different centers and also including those from the Office of the Commissioner. The Center for Biologics Evaluation and Research (CBER) http://www.fda.gov/cber/guidelines.htm Find information regarding the different types of products CBER regulates, read documents frequently requested by the Freedom of Information Act, and learn about training programs, meetings, and research in this area. The Manual of Regulatory Standard Operating Procedures and Policies http://www.fda.gov/cber/regsopp/regsopp.htm This manual covers the procedures and policies that are in place for operations that take place within the FDA. The Center for Drug Evaluation and Research (CDER) http://www.fda.gov/cder/ The official site for the drug branch of the FDA, which includes news, general safety and side effects information, new drug approvals, and alerts and warnings for approved drugs. Visitors can also find details on guidances developed by the agency and enforcement information. Sign up for E-mail to the CDER Web site http://www.fda.gov/cder/cdernew/listserv.html All available CDER mailing lists. Questions and Answers on Current Good Manufacturing Practices (cGMPs) for Drugs http://www.fda.gov/cder/guidance/cGMPs/default.htm CDER's question and answer resource on the meaning and application of cGMPs for drugs. The Data Standards Manual http://www.fda.gov/cder/dsm/index.htm This manual compiles all of the standardized nomenclature monographs that have been reviewed and approved by the FDA Data Standards Council. Guidance documents specific to CDER http://www.fda.gov/cder/guidance/index.htm A record of guidance documents arranged by subject, as well as links to additional information about guidances, including updated lists of ones that are new, revised, or withdrawn. The CDER Handbook http://www.fda.gov/cder/handbook/index.htm Users can find information on all of the review and approval processes CDER is responsible for, contact details for people within the Center, as well as a search option for FDA acronyms and abbreviations. CDER's regulatory guidance section http://www.fda.gov/cder/regulatory A comprehensive list of CDER's guidances and enforcement information. The Office of Regulatory Affairs (ORA) http://www.fda.gov/ora A resourceful site that includes compliance, inspectional, and science references, a list of popularly requested documents, recent ORA publications, and hot topics, such as training courses, GLP and AIP lists, and ORA events. FDA and ORA site http://www.fda.gov/ora/compliance%5Fref Find links to all content related to Compliance References used by FDA personnel . The Compliance Policy Guide http://www.fda.gov/ora/compliance%5Fref/cpg Revisions and updates to ORA's Compliance Policy Guides Manual, dating from 1998 to present. Guide to Inspections http://www.fda.gov/ora/inspect_ref/igs/iglist.html This site provides reference materials for investigators and FDA personnel for inspections. The Guide to Inspection of Quality Systems http://www.fda.gov/ora/inspect_ref/igs/qsit/qsitguide.htm A document providing guidance to FDA field staff on a new inspectional process, the Quality System Inspection Technique . ADDITIONAL GOVERNMENT SITES Centers for Medicare Medicaid Services http://www.cms.hhs.gov This site provides a listing of different CMS programs and detailed information for each, an up-to-date newsroom, the top 10 links on the site, as well as numerous links related to research, statistics, and data. Children and Clinical Studies http://www.nhlbi.nih.gov/childrenandclinicalstudies/index.php The National Heart Lung and Blood Institute here offers an entire site dedicated to the practice of clinical research in children. European Medicines Agency http://www.emea.europa.eu The official EMEA site includes basic Agency information, including its committees, events, meetings, job opportunities, and press releases. Beyond this, there's information on products, EU legislation, and emerging science. National Institutes of Health http://www.nih.gov Along with a detailed overview of the Agency, the site provides an A-Z index of health topics, grant information, current industry news, research results, and a listing of the institutes, centers, and offices that make up the NIH. Agency for Healthcare Research and Quality (AHRQ) http://www.ahrq.gov AHRQ supplies a variety of clinical information ranging from scientific reviews, treatment and research findings, comparative clinical effectiveness, and technology reviews to current and archived clinical practice guidelines. BLOGS Applied Clinical Trials Blog The Applied Clinical Trials blog offers area of discussion on news and analysis of the business and trends in the clinical trials industry. BioClinica Trial Blazers Blog http://info.bioclinica.com/blog BioClinica's Trial Blazers blog covers the latest news on clinical trials direct from industry experts. Carl's Blog on FDA Stuff http://carl1anderson.wordpress.com/ Carl Anderson, a regulatory affairs and quality assurance consultant, provides current information about issues pertaining to the FDA. The blog also has links to organizations and relevant articles. ClinPage www.clinpage.com Offers a broad range of industry news, events, statistics, and trends. Users can also find podcasts of interviews with clinical trials professionals. Drug and Device Law http://druganddevicelaw.blogspot.com This blog is devoted to discussing topics related to pharmaceutical and medical device product liability litigation. EyeOnFDA http://www.eyeonfda.com This blog covers the regulatory aspects of medical products. Users can also find FDA links, industry news updates, and links to relevant videos on YouTube. In the Pipeline http://pipeline.corante.com Authored by an organic chemist, this blog focuses on the science side of drug discovery. With daily posts it touches upon topics in the news and issues arising in industry keeping readers in touch with what's happening. The In Vivo Blog http://invivoblog.blogspot.com Here readers can find daily commentary on recent developments in bio- pharmaceutical business development, drug development, finance, marketing, and policy. Medical Translation Blog http://blog.fxtrans.com/ Created by Foreign Exchange Translations, a medical translation company, this blog provides content on regulatory issues, technology, and of course, topics of medical translation. Pharmaceutical Executive http://blog.pharmexec.com/ Discourse, dialogue, and discussion about global pharma matters. Pharmalot http://www.pharmalot.com/ Information on all topics of concern to professionals in the drug development industry as well as an up-to-date listing of news. PRIMR's Amprsand http://primr.blogspot.com Public Responsibility in Medicine and Research (PRIMR) provides through its blog, discussions on ethic-related topics. Wall Street Journal's Health Blog http://blogs.wsj.com/health Covering health and the business of health, WSJ's health blog presents analysis of the latest news in industry. TOOLS Applied Clinical Trial's Professional Associations Listing Interdisciplinary networking, publications, and conferences are a few of the benefits of society membership. Applied Clinical Trial's Training and Education Directory Organizations offering courses and classes designed to broaden your clinical trials knowledge base. Canada Trials http://canadatrials.com Both patients and researchers can find here clinical trials information in Canada. Along with finding medical news, patients can find support groups, researchers can post a trial, and sponsors can search center profiles. CDISC Acronyms, Abbreviations, and Initials These translations help make sense of initials commonly used by clinical researchers around the world. CDISC Clinical Research Glossary A newly updated glossary that includes even more terms relevant to clinical trials professionals. CenterWatch Clinical Trials Listing Service www.centerwatch.com Beyond being a global news source for clinical research professionals and patients, CenterWatch offers directories, analysis, and market research. Clinicaltrials.gov http://www.clinicaltrials.gov As a service of the U.S. National Institutes of Health this is a registry of federally and privately supported clinical trials conducted globally. The Federal Register http://www.gpoaccess.gov/fr/index.html A Web-based filing of the rules, proposed rules, and notices of Federal agencies and organizations, as well as executive orders and other presidential documents, which are provided from the year 2000 and on. PhRMA Clinical Study Results Database www.clinicalstudyresults.org A Web-based repository for clinical study results presented in a reader- friendly, standardized format. Practical Considerations for Clinical Trial Sites Using Electronic Health Records Certified for Clinical Research www.eclinicalforum.org/Default.aspx?id=75tabid=54 This paper from the EHRCR Project addresses regulatory considerations regarding clinical trial sites using electronic health records. WHO International Clinical Trials Registry Platform (ICTRP) www.who.int/ictrp/en This site facilitates access to worldwide information about controlled trials and their results, trial registration, datasets, and news.
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