Study Start Up

  • confidentiality disclosure agreements.
  • site feasibility assessments and questionnaires.
  • review of protocol with Investigator to ensure interest in the study, protocol integrity, resources for the successful conduct of the study were available, and the study is fiscally reasonable
  • pre-site/site qualification visits
  • budget review and negotiations with Sponsor
  • PI, Director, and in-house legal review and completion of investigator and site agreements and contracts
  • compilation of signed and dated CVs, licenses, and financial disclosure statements for investigators, coordinators, and assistants
  • receipt and review of protocol, manuals, investigational brochures, and package inserts
  • develop comprehensive study-specific plan, goals, timeline, budget, and assignments
  • submission of protocol, informed consent, HIPAA authorizations, 1572s, CVs/licenses, financial disclosure statements, requested SOPs, etc. to the IRB
  • review, modification, and approval of ICF and HIPAA Authorization drafts
  • upon sponsor and IRB approvals:
    • set up regulatory, site correspondence, safety reports, and laboratory binders;
    • prepare source documents and logs;
    • obtain all necessary study study supplies;
    • prepare new patient packets;
    • assure team training completion and access for IXRS, EDC/RDC, and other study-specific portals (eg, eRT, ePRO diaries, etc);
    • develop study logs, case report forms, advertisement/recruitment materials, study hand-outs, questionnaires, etc.;
    • ensure site receipt, registration, and documentation of investigational products and equipment;
    • schedule team for investigator meeting;
    • direct and prepare site and staff for site initiation visits
    • complete delegation of duties log.