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  Training
 
The investigators and staff at GSCIN take regulations and training very seriously.  GCP training is ongoing and we participate in live, web based and written media formats to remain educated to uphold the highest quality of standards.  All study coordinators hold IATA certifications and are up to date on CPR certifications.  Our staff has regular HIPPA training to protect subject information and OSHA guidelines to ensure site safety. 

We have had experience with many IVRS third party vendors such as Bracket, ICON and ClinPhone.We are familiar with IRB regulations including Copernicus, Quorum, Chesapeake, Schulman and IRB Services. We have also experience with various EDC sytemss like Medidata Rave, Oracle, Inform, Medrio and eClinical.
  Regulations We follow:
 
  • ICH E6
  • 21 CFR 50
  • OHRP
  • 45 CFR 46
  • Belmont Report
  • Declaration of Helsinki
  • GCP
  • OSHA
  • HIPPA
 
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