Study Implementation

We provide expertise and guidance on completion of a variety of research forms and regulatory documents required when implementing a clinical study.

Regulatory consultations are available to guide and support you as you design protocols, navigate through the approval process, and conduct your research.

Services include:

  • Guidance with protocol development
  • IRB application guidance and review
  • Guidance responding to IRB contingencies
  • Consent form development
  • Consent process guidance
  • Regulatory document guidance
  • Guidance with study implementation
  • Guidance with ClinicalTrials.gov registration and results posting requirements

Protocol and IRB Development

Investigators who need help developing their clinical protocols are welcome to contact the TraCS Regulatory Service.

We are available to provide guidance in developing or writing a clinical protocol or preparing an IRB submission. If it is determined that you could benefit from additional scientific or bio-statistical expertise, we will make an appropriate referral.

Links and guidance documents to help in developing a research protocol:

Request help with Study Implementation