General Protocols
What is the primary purpose of the HRP-503 General template?
It is used for clinical trials, interventional studies, or studies with patient interaction.
What type of research is the HRP-503 Surveys and Interviews template designed for?
Non-invasive studies such as surveys, interviews, focus groups, and observations.
What is the HRP-503 Record Data template used for?
Studies analyzing medical records or data retrospectively or prospectively without patient interaction.
What is the primary purpose of the HRP-503 Medical Record Review template?
For retrospective chart reviews within UCD and not federally funded.
What does IRB stand for?
Institutional Review Board.
Why is the HRP-503 General template more detailed than other templates?
Because it is designed for studies requiring more regulatory and compliance information due to direct patient interaction.
What feature differentiates the Surveys and Interviews template from the General template?
It includes formatted sections with checkboxes for easier completion.
Why does this template often require a waiver of consent?
Because there is no direct patient interaction, and the study involves secondary data.
How many sections does the Medical Record Review template have?
Only four sections.
Why is a protocol required for IRB review?
It outlines the scientific method and ensures a well-designed study.
Which section allows researchers to outline the research workflow?
What is the focus of the "Procedures Involved" section in the Surveys and Interviews template?
How surveys, interviews, or observations will be conducted.
What makes the Record Data template longer and more detailed than the Medical Record Review template?
It accounts for a broader range of research types, including federally funded or multi-site studies.
What is the main restriction for using the Medical Record Review template?
It must be used only for studies involving UC Davis EMR data and not federally funded.
What is IRBNet?
What type of study does the HRP-503 General template often involve?
More-than-minimal-risk studies requiring detailed descriptions of patient consent and data handling.
How does this template simplify data collection explanations?
By using pre-formatted sections and checkboxes for standardized answers.
What is a key difference in consent requirements between Record Data and General templates?
Why is this template more simplified than the Record Data template?
What is the code name for the general protocol template?
HRP-503.
How does the HRP-503 General template differ in consent requirements compared to the Surveys and Interviews template?
The HRP-503 General template requires detailed written consent processes due to patient interaction, while the Surveys and Interviews template often relies on simplified or implied consent mechanisms for non-invasive studies.
What are two key reasons for using the HRP-503 Surveys and Interviews template instead of the HRP-503 General template?
In what scenarios should you not use the HRP-503 Record Data template, and what alternative should be chosen instead?
What are the potential risks of using the HRP-503 Medical Record Review template incorrectly for a study that does not meet its specific criteria?
What are three key elements that must be included in any protocol submitted to the IRB to ensure approval?