Industry Information

EthosExcel™ has listed a number of resources found on the internet here for your convenience. We feel these resources can be particularly useful for prospective or current Principal Investigators or those considering a career in clinical research.
Clinical Trials Information: http://www.clinicaltrials.gov US Office of Human Subject Research Protections (OHRP): http://www.hhs.gov/ohrp/about Clinical Research Standards: http://www.cc.nih.gov/ccc/clinicalresearch/standards1.html Convention of Human Rights and Biomedecine - Council of Europe (Spain, April 4, 1997): http://conventions.coe.int/treaty/en/treaties/html/164.htm Data Safety Monitoring for Phase I and II Trials: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html FDA: http://www.fda.gov FDA Regulations Relating to Good Clinical Practice and Clinical Trials: http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ucm114928.htm FDA Guidance Documents: http://www.fda.gov/RegulatoryInformation/Guidances/default.htm Human Subjects Protections, 21 CFR 50: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRsearch.cfm?CFRPart=50 Investigational Drugs, 21 CFR 312: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=312 Subpart D--Responsibilities of Sponsors and Investigators
  • 312.50 - General responsibilities of sponsors.
  • 312.52 - Transfer of obligations to a contract research organization.
  • 312.53 - Selecting investigators and monitors.
  • 312.54 - Emergency research under 50.24 of this chapter.
  • 312.55 - Informing investigators.
  • 312.56 - Review of ongoing investigations.
  • 312.57 - Recordkeeping and record retention.
  • 312.58 - Inspection of sponsor's records and reports.
  • 312.59 - Disposition of unused supply of investigational drug.
  • 312.60 - General responsibilities of investigators.
  • 312.61 - Control of the investigational drug.
  • 312.62 - Investigator recordkeeping and record retention.
  • 312.64 - Investigator reports.
  • 312.66 - Assurance of IRB review.
  • 312.68 - Inspection of investigator's records and reports.
  • 312.69 - Handling of controlled substances.
  • 312.70 - Disqualification of a clinical investigator.
Investigational Devices, 21 CFR 812: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=812 Good Clinical Practice Home Page: http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/default.htm Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance (April 1996): http://www.fda.gov/RegulatoryInformation/Guidances/ucm122049.htm Good Clinical Practice: Consolidated Guidance - International Conference on Harmonisation (ICH): http://www.ich.org/products/guidelines.html Guidelines for Good Clinical Practice for Trials on Pharmaceutical Products – Geneva, World Health Organization (1995): http://www.who.int/topics/pharmaceutical_products/en/ National Library of Medicine (NLM): http://www.nlm.nih.gov/ National Statement on Ethical Conduct in Research Involving Humans – National Health and Medical Research Council (Australia, 1999): http://www.nhmrc.gov.au/publications/synopses/e35syn.htm US Office of Human Subjects Research (OHSR): http://ohsr.od.nih.gov     Comparison of FDA and HHS Human Subject Protection Regulations: http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/EducationalMaterials/ucm112910.htm IRB-member training: http://ohsr.od.nih.gov/IRBCBT/intro.php To find current Federal Wide Assurance (FWA) Numbers: http://www.hhs.gov/ohrp/assurances/assurances_index.html Professional Affiliations:

Date

Conferences & Meetings

Location

4/21/2013

22nd Annual Partnerships in Clinical Trials Read More >

Orlando, FL

4/22/2013

Washington: National Minority Quality Forum Read More >

Washington, DC

5/7/2013

22nd Annual Outsourcing in Clinical Trials Southeast Read More >

Cary, NC

5/20/2013

6th Annual Diversity Alliance for Science Read More >

Newark, NJ

6/20/2013

Old North State - 126th Annual Scientific Assembly Read More >

Greensboro, NC

6/23/2013

DIA 2013 49th Annual Meeting Read More >

Boston, MA

6/25/2013

Women's Business Enterprise National Council (WBENC) 2013 National Conference & Business Fair Read More >

Minneapolis, MN

7/27/2013

National Medical Association Annual Convention Read More >

Toronto, Canada

9/26/2013

SoCRA 22nd Annual Conference Read More >

New Orleans, LA