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Frequently Asked Questions

Investigator Initiated Trial Services at the U (IITS-U)

Regulatory Affairs

  • What are essential regulatory documents?

  • What is ICH E6 Good Clinical Practice (GCP)?

  • What is an eTMF?

  • Who is responsible for the eTMF maintenance and accuracy?

Project Management

  • What does a IITSU clinical research project manager do for your study?

  • What are the advantages of having a project manager from CRMSO?

  • How will I interact with my assigned Project manager?

  • What type of reports can I expect from the Project Manager of my study?

Site Management

  • What does a clinical research monitor do?

  • How does IITSU develop a monitoring plan?

  • What are the different types of clinical monitoring?

  • What types of monitoring visits will occur during my study?

  • What occurs at each type of monitoring visit?

  • How can my site prepare for a monitoring visit?

Data Management

  • What is the goal of data management in the clinical trial process?

  • What does a IITSU data manager do?

  • What are the advantages of having a IITSU data manager on your team?

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