Document Retention and Disposal

The study team must comply with all applicable regulations for document retention, storage and disposal once the research study has been completed. Further information on the processes for studies that handle investigational drugs and devices, or include external devices, such as hard-drives or flash-drives, are also explained.

Study Closeout or Termination

Information regarding the course of action for study close-outs, study terminations and financial close-outs for a research study. Includes details pertaining to the IRB, GCO, IDS, EPIC and other ancillary departments.

Monitoring and Audits

How study teams can prepare for internal audits, by the Research Compliance Office at ISMMS, or external agency audits by the FDA or OHRP, and routinely monitoring visits by the study sponsor or CRO. The purpose of these visits are to ensure the research study is compliant with the study protocol and the GCP/HSP regulatory requirements.

Financial Management

Information on the financial management of industry initiated clinical trials, including generating a fund number, invoicing, study and research subject payments.

Study Management

Information on managing and maintaining regulatory compliance throughout the duration of the research study. This includes regulatory compliance resources, essential documents for the study’s regulatory binder, GCO annual submissions, IRB modifications and continuations.

  • Regulatory Compliance Education & Resources
  • Essential Documents – Regulatory Binder

Site Initiation Visit (SIV)

Prior to study enrollment, the study monitor on behalf of the sponsor will conduct a Site Initiation Visit (SIV) to provide the principal investigator and the study team training on the protocol, procedures, processes and monitoring plan.

GCO Submission

Instructions are provided for the Grants & Contracts Office InfoEd submission process, including steps to finalize and submit the application, contact information for the departmental assigned GCO specialist and approval routing process.

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Contracts & Budget Submission

Guidance on the submission process pertaining to For-Profit (Industry) clinical trial agreements to the Financial Administration of Clinical Trials Services (FACTS) Office. Further detail on budget development and negotiations are also provided.