The first step is to develop a plan for how you want to conduct your research. In addition to the IRB application, this plan could include the creation of documents such as a protocol, consent form(s), study data collection instruments, and instructions (e.g. standard operating procedures).
Informed Consent Development
The next step is conducting the study as approved, periodically re-assessing and making changes when needed.
Screening and Recruitment
Consent Processes and Documentation
HRP - 090 - SOP - Informed Consent Process for Research
HRP - 091 -SOP - Written Documentation of Consent
Professional Research Education Program (PREP) training videos
Investigating the Cause of Noncompliance and Implementing Corrective and Preventive Action (CAPA) Plans
IRB Reportable Events and How to Prevent Them (video)
Identifying, Documenting, and Reporting (Serious) Adverse Events (video)
Changes of Protocol
Developing an Internal Quality Assurance (QA) Program Guidance
Post-Approval Monitoring Program Self-Assessment Tool
ICTR Clinical Research Toolkit (Self-Assessment & Audit Prep tab)
The final step is initiating the IRB closure process and ensuring proper retention of study records.