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(Revised January 2007)
| Website | URL |
|---|---|
| FDA Websites | |
| Archiving Submissions in Electronic Format | www.fda.gov/cder/guidance/arcguide.pdf |
| Bioresearch Monitoring Information System File: Clinical Investigators, CROs and IRBs from FDA 1571 & 1572s | www.fda.gov/cder/foi/special/bmis/index.htm |
| CDER Guidance Documents | www.fda.gov/cder/guidance/index.htm |
| CDER Organizational Chart | www.fda.gov/cder/cderorg.htm |
| CDRH Bioresearch Monitoring | www.fda.gov/cdrh/comp/bimo.html |
| CDRH Device Advice | www.fda.gov/cdrh/devadvice/ |
| CDRH Organization Structure | www.fda.gov/cdrh/organiz.html |
| Clinical Investigator Disqualifications Proceedings | www.fda.gov/foi/clinicaldis/ |
| FDA/ORA Bioresearch Monitoring Information | www.fda.gov/ora/compliance_ref/bimo/ |
| Drug Approvals List | www.fda.gov/cder/da/da.htm |
| Electronic Regulatory Submissions and Review | http://www.fda.gov/cder/regulatory/ersr/default.htm |
| Expedited Safety Reporting Requirements Oct 7, 1997 Federal Register Final rule | http://www.fda.gov/cder/regulatory/default.htm
click on: (federal register - GPO)(Federal register)(1997) (final rules & regulations) enter date: (on 10/07/1997) search terms: (expedited) |
| FDA Debarred Persons List | http://www.fda.gov/ora/compliance_ref/debar/default.htm |
| FDA Disqualified/Restricted/Assurances Lists for Clinical Investigators | www.fda.gov/ora/compliance_ref/bimo/dis_res_assur.htm |
| FDA Dockets | http://www.fda.gov/ohrms/dockets/default.htm |
| FDA Letters Providing Clinical Investigators with Notice of Initiation of Disqualification Proceedings and Opportunity to Explain | www.fda.gov/foi/nidpoe/default.html |
| FDA Modernization Act of 1997 CDRH Guidance CDER-Related Documents |
www.fda.gov/cder/guidance/105-115.htm www.fda.gov/cdrh/modact/modguid.html http://www.fda.gov/cder/fdama/default.htm |
| FD&C Act | www.fda.gov/opacom/laws/fdcact/fdctoc.htm |
| Freedom of Information Reading Room | http://www.fda.gov/foi/ |
| Information for Health Professionals | http://www.fda.gov/oc/oha/default.htm |
| International Conference on Harmonisation | http://www.fda.gov/cder/guidance/index.htm#International%20Conference%20on%20Harmonization%20-%20%20Efficacy |
| Investigational Human Drugs Clinical Investigator Inspection List |
www.fda.gov/cder/regulatory/investigators/default.htm |
| Investigational Device Exemptions (IDE) Policies and Procedures | http://www.fda.gov/cdrh/ode/idepolcy.pdf |
| Laws Enforced by FDA | http://www.fda.gov/opacom/laws/ |
| MedWatch | http://www.fda.gov/medwatch/ |
| National Drug Code (NDC) directory | http://www.fda.gov/cder/ndc/index.htm |
| New Drug Approval Packages | http://www.fda.gov/cder/foi/nda/index.htm |
| Orange Book (Approved Drugs) | www.fda.gov/cder/orange/adp.htm |
| Pediatric Medicine Page | www.fda.gov/cder/pediatric/ |
| Pharmacy Compounding | http://www.fda.gov/cder/pharmcomp/default.htm |
| Warning letters | www.fda.gov/foi/warning.htm |
| Non-FDA Websites | |
| Clinical Trials Registry | http://www.clinicaltrials.gov/ |
| Government Printing Office (Federal Register, Code of Federal Regulations, Congressional Record) | http://www.gpoaccess.ov/cfr/idex.html/ |
| HHS Employee and Organizational Directory | directory.psc.gov |
| Institute of Medicine of the National Academy of Sciences | www.iom.edu/IOM/IOMHome.nsf/Pages/human+research+protections |
| National Bioethics Advisory Comm.
(The charter for this commission has expired and the site is archived at this URL.) |
http://bioethics.georgetown.edu/nbac/ |
| Office for Human Research Protections (OHRP) | http://www.hhs.gov/ohrp |
| OHRP Advisory Committee | http://www.hhs.gov/ohrp/sachrp/ |
| OHRP IRB Guidebook | http://www.hhs.gov/ohrp/irb/irb_guidebook.htm |
| OHRP Policy Guidance | http://www.hhs.gov/ohrp/policy/index.html |
| PHS List of Investigators Subject to Administrative Action: | http://silk.nih.gov/public/cbz1bje.@www.orilist.html |
| VA Research and Development | www1.va.gov/resdev/funding/ |
| Basic Statistics in Clinical Trials | |
| American Statistical Association | http://www.amstat.org/index.cfm?fuseaction=main |
| International Statistical Institute | http://isi.cbs.nl/ |
| ITCWeb: Introduction to SAS Version 8.2 | http://www.itc.virginia.edu/research/sas/training/v8/ |
| ITS Research Consulting | http://www.utexas.edu/its/rc/answers/ |
| Rice Virtual Lab in Statistics | http://onlinestatbook.com/rvls.html |
| SAS | Statistics | http://www.sas.com/technologies/analytics/statistics/index.html |
| SAS: Online Training | http://dss.princeton.edu/online_help/stats_packages/sas/sas_tutorial/59322/index.htm |
| SAS: What you Need To Know to Write a SAS Program | http://www.columbia.edu/acis/eds/stat_pak/sas/sas-write.html |
| SPSS | Analytical Process | http://www.spss.com/spss/analytical_process.htm |
| SRC Data Library - Introduction to Data Handling | http://www.src.uchicago.edu/datalib/DLguides/Gdathand.html |
| Statistics - Wikipedia | http://en.wikipedia.org/wiki/Statistics |
| Talking About Statistics | http://www.talkingquality.gov/docs/section3/3_3.htm |
| The Royal Statistical Society | http://www.rss.org.uk/main.asp?page=0 |
| The Statistics Homepage: Statsoft | http://www.statsoft.com/textbook/stathome.html |
| Clinical Data Management (CDM) | |
| Biomedical Research Integrated Domain Group (BRIDG) | http://www.bridgproject.org/ |
| mEDRA - multilingual European Registration Agency | http://www.medra.org/ |
| OpenClinica | http://openclinica.org/ |
| Society For Clinical Data Management (SCDM) | http://www.scdm.org/ |
| Writing & Reporting | |
| CONSORT - Strength in science, sound ethics | http://www.consort-statement.org/ |
| ICH - Efficacy Guidelines | http://www.ich.org/cache/compo/276-254-1.html |
| ICMJE - Uniform Requirements for Manuscripts Submitted to Biomedical Journals | http://www.icmje.org/ |
| Guideline for Industry - Structure and Content of Clinical Study Reports | http://www.fda.gov/cder/guidance/iche3.pdf |
| PubMed Central (PMC) - U.S. Nationial Institutes of Health (NIH) Archive of Biomedical and Life Sciences Journal Liturature | http://www.pubmedcentral.nih.gov/ |
| NIH OHSR - Guidelines for Writing Informed Consent Documents | http://ohsr.od.nih.gov/info/sheet6.html |
| NIH OHSR - Guidelines for Writing Research Protocols | http://ohsr.od.nih.gov/info/sheet5.html |
| The Council of Science Editors (CSE) | http://www.councilscienceeditors.org/services/authorship.cfm |
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