IRB Submissions
This type of IRB submission is commonly used to request approval for a change to an already-approved study.
What is an amendment/modification submission?
What are two elements that make data attributable?
What are two elements that make data attributable?
This document provides detailed instructions for conducting a clinical trial.
What is the protocol?
No full-board discussion is needed for this category of research, provided the study meets the applicable regulatory criteria and the institution makes the appropriate determination.
What is an exempt determination?
This person is responsible for ensuring that a clinical trial is conducted according to the protocol, applicable regulations, and Good Clinical Practice.
Who is the investigator?
This IRB submission is commonly used to notify the IRB of a change in study personnel, when permitted under institutional procedures.
What is a change of key personnel?
Also what is an amendment? is acceptable
When delegating study tasks and procedures, the PI should consider what important question about the individuals she is assigning tasks to?
What is: Is this person appropriately qualified and trained?
This document contains information about an investigational drug's properties, clinical and nonclinical data, and guidance for investigators.
What is the Investigator's Brochure?
A study that has potential for greater than minimal risk is review recieves this type of IRB review.
What is Full Committee Review?
This document describes the objectives, design, methodology, statistical considerations, and organization of a clinical trial.
What is the protocol?
This periodic re-evaluation of an ongoing research study by the IRB is done to ensure risks remain minimized and reasonable and confirm that the participant protections are adequate.
What is Reportable New Information (RNI)/ Reportable Events and New Information (RENI)?
The PI has an idea that all incividuals coming in for a screening visit will get research vital signs done first thing, before anything else. What GCP requirement was not met?
What is informed consent before research procedures?
This document records the agreement between the sponsor and investigator regarding responsibilities and obligations for conducting the clinical trial.
What is the clinical trial agreement?
When a study involves no more than minimal risk and meets specified regulatory categories, this review pathway may be used for initial or, when applicable, continuing IRB review.
What is expedited review?
This international ethical and scientific standard provides guidance for conducting clinical trials involving human participants.
What is Good Clinical Practice (GCP)?
Double Trouble
The case of the outdated ICF
A participant misses a required study visit within the allowed window. The coordinator decides nothing needs to be done because no harm occurred. This GCP responsibility has been overlooked.
What is recording or reporting a deviation?
This essential document records that a participant has voluntarily agreed to participate after receiving required information about the study.
What is the informed consent form/documentation?
A researcher plans to use data from individuals who are deceased. Because federal human-subjects regulations generally define a “human subject” as a living individual, this type of project may receive this IRB determination rather than undergoing expedited or full-board review.
What is a “Not Human Subjects Research” determination?
This process ensures that a participant understands the research, including its risks and benefits, before voluntarily agreeing to participate.
What is informed consent?
Protocol non-complianace that could impact the safety of subjects or quaility of data should be promptly reported in this type of submission.
What is a protocol deviation submission?
A RENI or RNI report would also be acceptable
The study coordinator decided it would be easier to save just the signature page of the consent form, since it included the participant's signature and the IRB stamp. What GCP requirement has been overlooked?
What is the requirement to keep adequate and accurate records?
These records demonstrate that a clinical trial was conducted according to the protocol, GCP, and applicable regulatory requirements.
What are essential documents?
Minimal risk alone does not automatically determine the pathway. The IRB considers the project’s procedures, participant involvement, and applicable regulatory categories before determining whether the study qualifies for an exemption, expedited review, or review by the convened board.
What are the three possible levels of IRB oversight?
This type of study is designed to compare an intervention against a control or comparator to determine its effects.
What is a controlled clinical trial?