Resources & Links
Useful Resources in Clinical Research
- Association of Clinical Research Professionals (ACRP)
http://www.acrpnet.org - Association of Patient Oriented Research (APOR)
http://www.apor.org - CDER Warning Letters
http://www.fda.gov/cder/warn/ - CDER- Division of Scientific Investigations
http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090085.htm - Center for Drug Evaluation and Research (CDER)
http://www.fda.gov/cder/ - Centers for Disease Control and Prevention (CDC)
http://www.cdc.gov/ - CenterWatch- Clinical Trials Listing Service
http://www.centerwatch.com/ - Debarment List of Clinical Investigators
http://www.fda.gov/ora/compliance_ref/debar/default.htm - Declaration of Helsinki
http://www.cirp.org/library/ethics/helsinki - Disqualified/Restricted Lists of Clinical Investigators
http://www.fda.gov/ora/compliance_ref/bimo/dis_res_assur.htm - Drug Information Association (DIA)
http://www.diahome.org - FDA 21CFR Part 54- (Financial Disclosure)
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=54 - FDA Enforcement Action Links
http://www.fda.gov/ora/compliance_ref/part11/default.htm - FDA Guidance Document Index- IRBs, Investigators and Sponsors
http://WWW.FDA.GOV/OC/OHRT/IRBS/DEFAULT.HTM - FDA Information Sheet Guidance Document
http://www.fda.gov/oc/ohrt/irbs/investigator.pdf - FDA- 21CFR Part 312 (NDA and Investigator Responsibilities)
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=312 - FDA- 21CFR Part 50 (Protection of Human Subjects- Informed Consent)
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=50 - FDA- 21CFR Part 56- (IRBs)
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=56 - FDA- 21CFR Part 812 (Medical Devices)
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=812 - FDA- Compliance Programs
http://www.fda.gov/ora/compliance_ref/default.htm - FDA- Form 1572
http://www.fda.gov/opacom/morechoices/fdaforms/FDA-1572_508.pdf - FDA- MedWatch (Safety Information and AE Reporting Program)
http://www.fda.gov/medwatch/ - Food and Drug Administration (FDA)
http://www.fda.gov - Health A to Z- (a general health information website)
http://www.healthatoz.com/healthatoz/Atoz/clients/haz/general/custom/default.jsp - Health and Human Services (HHS)- FAQ
http://www.answers.hhs.gov/ - HIPAA Glossary
http://www.wedi.org/public/articles/hipaa_glossary.pdf - HIPAA Guidance Document
http://privacyruleandresearch.nih.gov/pdf/clin_research.pdf - HIPAA Preemption Charts
http://www.health.state.ny.us/nysdoh/hipaa/hipaa_preemption_charts.htm - HIPAA- Office of Civil Rights (OCR)
http://www.hhs.gov/ocr/hipaa/ - HIPAA- Privacy Violations
http://www.ama-assn.org/ama/pub/physician-resources/solutions-managing-your-practice/coding-billing-insurance/hipaahealth-insurance-portability-accountability-act/hipaa-violations-enforcement.shtml - ICH Homepage
http://www.ich.org/ - ICH- GCP Guidelines
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002874.pdf - Medscape- On-line Medical Reference Homepage
http://www.medscape.com/home - National Cancer Institute of Canada- Clinical Trials Group
http://www.ctg.queensu.ca/ - National Institute of Health (NIH)
http://www.nih.gov - Oncolink- Online Oncology Resource Homepage
http://www.oncolink.com/ - Research Investigators Source, Inc
http://www.clinicalinvestigators.com/index.html - Research Nurse .Com
http://www.researchnurse.com/ - SOCRA Homepage
http://www.socra.org