Resources
Clinical Trial Services Downloads
Weathering the Perfect Storm
Running thorough QT/QTc studies can be prevented by oncology drug toxicity. William Wheeler, at Spacelabs, considers solutions to this complex drug development problem
Increasing Efficiency of Ambulatory Blood Pressure Monitoring in Clinical Trials
Success Story Completed with Socket Communications - www.socketcom.com
The QT Intensive Study: Nuts and Bolts for Phase I Units
(published in the Summer 2006 edition of European Pharmaceutical Contractor)
Guidance for Industry E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs
Implications of ICH E14 for the Clinical Research Industry
by William Wheeler, MD, Chief Medical Officer
Regulatory and Governmental Agencies
Centers for Disease Control and Prevention
www.cdc.gov
ClinicalTrials.gov
www.clinicaltrials.gov
EudraVigilance
www.eudravigilance.org
European Clinical Trials Database
www.eudract.emea.eu.int
European Medicines Agency
www.emea.eu.int
Federal Register
www.gpoaccess.gov/fr/index.html
International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) www.ich.org
- International Conference on Harmonization
www.fda.gov - ICH email address to pose questions on E14
E14@ich.org
International Federation of Pharmaceutical Manufacturers & Associations
www.ifpma.org
National Heart, Lung, and Blood Institute
www.nhlbi.nih.gov
National Institutes of Health (NIH) www.nih.gov
- NIH LISTSERV for FDA GCP
https://list.nih.gov/cgi-bin/wa?SUBED1=fdagcpp&A=1 - NIH Clinical Research Studies
http://clinicalstudies.info.nih.gov
National Library of Medicine
http://clinicalstudies.info.nih.gov
Office for Human Research Protections
www.hhs.gov/ohrp
US Food and Drug Adminstration (FDA) www.fda.gov
- FDA 21 CFR Search Database
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/ cfrsearch.cfm - FDA Center for Biologics Evaluation and Research
www.fda.gov/cber - FDA Center for Drug Evaluation Research
www.fda.gov/cder - FDA Good Clinical Practices
www.fda.gov/oc/gcp/default.htm - FDA Guidance Documents
www.fda.gov/opacom/morechoices/industry/guidedc.htm - FDA Guidance for IRBs and Clinical Investigators
www.fda.gov/oc/ohrt/irbs/default.htm - FDA Manuals, Regulatory Publications, and Reports
www.fda.gov/opacom/7pubs.html
Industry Organizations/Publications
Applied Clinical Trials
www.actmagazine.com
Association of Clinical Research Professionals
www.acrpnet.org
BioSpace
www.biospace.com
Biotechnology Industry Organization
www.bio.org
BioWorld Online
www.bioworld.com
CenterWatch Clinical Trials Listing Service
www.centerwatch.com
Drug Information Association
www.diahome.org
Institute of Clinical Research
www.instituteofclinicalresearch.org
PhRMA.org
www.phrma.org
Regulatory Affairs Professionals Society
www.raps.org
Society for Clinical Data Management
www.scdm.org
Society of Clinical Research Associates
www.socra.org
Society for Clinical Trials
www.sctweb.org
Professional Societies
American College of Cardiology (ACC)
www.acc.org
American Heart Association (AHA)
www.americanheart.org
American Society of Hypertension
www.ash-us.org
Cardiosource--American College of Cardiology
www.cardiosource.com
Cardiosource Index of Cardiology Journals
www.cardiosource.com/journals/index.asp
European Society of Cardiology
www.escardio.org
Heart Rhythm Society
www.hrsonline.org
International Society for Computerized Electrocardiology (ISCE)
www.isce.org
International Society for Holter and Noninvasive Electrocardiology (ISHNE)
www.ishne.org
theheart.org
www.theheart.org
Medical Journals
American Heart Journal
www.ahjonline.com
American Journal of Medicine
www.amjmed.com
Annals of Internal Medicine
www.annals.org
Annals of Noninvasive Electrocardiology--Official Journal of ISHNE
www.blackwellpublishing.com/journal.asp?ref=1082-720X
Archives of Internal Medicine
http://archinte.ama-assn.org
British Medical Journal
www.bmj.com
Cardiac Electrophysiology Society
www.cardiaceps.org
Circulation--Official Journal of AHA
www.circ.ahajournals.org
Contemporary Clinical Trials
www.journals.elsevierhealth.com/periodicals/concli
Current Controlled Trials
www.controlled-trials.com
Europace
www.escardiocontent.org/periodicals/yeupc
European Heart Journal
www.eurheartj.oxfordjournals.org
Heart & Lung--The Journal of Acute and Critical Care
www.journals.elsevierhealth.com/periodicals/ymhl
Heart Online
http://heart.bmjjournals.com
Heart Rhythm Journal
www.hrsonline.org/hr_journal/default.asp
International Journal of Cardiology
www.internationaljournalofcardiology.com
Journal of Clinical Research
www.pjbpubs.com/clinical_research/index.htm
Journal of Electrocardiology--Official Journal of ISCE and ISE
www.journals.elsevierhealth.com/periodicals/yjelc
Journal of Molecular and Cellular Cardiology
www.jmmc-online.com
Journal of the American College of Cardiology (JACC)
www.cardiosource.com/jacc/index.asp
Journal of the American Medical Associaton
http://jama.ama-assn.org
Resuscitation
www.resuscitationjournal.comg
The Lancet
www.thelancet.com
Trends in Cardiovascular Medicine
www.tcmonline.org
The New England Journal of Medicine
http://content.nejm.org
Trends in Cardiovascular Medicine
www.tcmonline.org
