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.
- 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:
- CTTI Recommendations: Quality by Design
- CTTI Principles of a Quality Protocol Document
- NIH-FDA Clinical Trials Protocol Template
- CTTI Recommendations: Efficient and Effective Clinical Trial Recruitment Planning
- Learn about the CTTI Quality by Design project at www.ctti-clinicaltrials.org
- Protocol Development Workshop (held Oct 31, 2018): slide set | view recording
- Presentation (Nov 2, 2018): Designing Your Research Study: Essential concepts, Best practices, Pitfalls, Speedy IRB approval (Presenter: Paul W. Stewart, PhD)
- UNC Scientific Review Committee (SRC)
- Online NIH Protocol Tool
- Spirit checklist
- Living Textbook of pragmatic clinical trials a collection of knowledge from the NIH Health Care Systems Research Collaboratory