As someone who is either interested in participating in a clinical research study or just someone who is interested in learning a little more about what research is, there are some important terms that you may come across that you should be familiar with.
Research Terms To Know
Informed Consent & the Informed Consent Form
A process where a participant is told/reads about what the study entails and decides whether they want to participate in that particular trial. The informed consent form communicates the potential risks and benefits of participating in a study. This also informs the participant of payment information, what they will do during the study and all other important information that they need to know. If they decide they do want to participate, they will sign the informed consent form (that has been IRB approved and is at a 6th-grade reading level). It will be signed and dated by both the participant and the study coordinator.
Screening Visit
A screening visit is the first visit a potential participant will come into the clinic for. First, the potential participant will read the informed consent form and will decide whether they want to participate. If they sign the informed consent form, then we will continue with the visit.
At this visit we will ask questions about medical history, medications, and other study-specific questions. Blood work will be done, as well as any additional procedures that need to be done for the study. The results of the questionnaires, labs, and procedures done during this visit will determine if the potential participant is able to continue and enter into the study.
Randomize
When a participant is randomized, this means that they have made it through the screening process and have officially entered into the study. We also refer to this as enrollment. It is at this visit that they would receive/begin the medication/treatment that the study is evaluating.
End of Screening
The end of screening date is the last day that we are able to bring people in for a visit to start the screening process (their very first visit). Marketing would end for the study at this point since we are no longer able to bring people in for their first visit.
End of Enrollment
The end of enrollment date is the last day that we can enroll (randomize) someone into the study from the screening process. After this day, we can no longer enroll people in the study. End of enrollment does not mean the end of the study. End of enrollment means they have reached the goal number of participants they need for their research.
Eligibility Criteria
List of criteria that determines if someone can participate in a study. The criteria include both inclusion and exclusion factors. This is to ensure it is safe for the participant to enter the study and there aren’t multiple outside factors influencing their health/behavior on the drug.
Open-Label Trial
A clinical trial is where all persons know which treatment they are receiving.
Double-Blinded Trial
A clinical trial where the study participant and all site staff do not know which treatment the participant is receiving.
Phases
Placebo
A placebo is a pill (or liquid, powder, etc.) that is inactive (some call them sugar pills) that is not the treatment. Placebos are often used to assess the study treatment’s effectiveness.
Protocol
A protocol is a document that contains all details of a study, including the objectives, design, and methods being used. They also include background & statistics that are relevant to the study.
Additional Terms Research Sites Use
If you want to know more about the research process as a provider or research worker, here are some additional terms that would be helpful to know.
Site Initiation Visit
This visit occurs once we have been awarded the study and all contracts have been signed so that we can go over the way everything will work in regard to visits during the study and what our responsibilities are.
Greenlight
Getting the green light means we can start bringing potential participants in to do a screening visit. We will typically get the green light within two weeks of our site initiation visit.
Good Clinical Practice
A standard for the design, conduct, performance, monitoring, auditing, recording, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of the participants are protected.
Institutional Review Board (IRB)
The IRB is an independent body consisting of medical, scientific, and nonscientific members whose responsibility it is to ensure the protection of the rights, safety, and well-being of human subjects involved in a trial by, among other things, reviewing, approving, and providing continuing review of trials, protocols, and amendments, and of the methods and material to be used to obtain and document informed consent of the participant.
Blinding
A procedure in which the investigator (PI) administering assessments and intervention, as well as the participants in the trial, are kept unaware of the treatment assignments. Single blinding refers to the study participant being unaware of their treatment, and double blinding usually refers to the study participant as well as the PI, site staff, monitors & data analysts not being aware of what treatment the participant is receiving.
Standard Operating Procedures (SOPs)
Detailed written instructions to achieve uniformity of the performance of a specific function across studies and patients at an individual site.
Treatment Arms:
A group/subgroup of participants that receive a specific treatment, or no treatment, according to the protocol.
Example: Treatment Arm A is 476 mg injection given every 2 weeks, Treatment Arm B is 476 mg injection given every 4 weeks and Treatment Arm C is the placebo given every 2 weeks.
Principal Investigator
A principal investigator (PI) is the primary investigator who is responsible for the scientific and technical direction of the study as a whole.
Sub-Investigator
A sub-investigator (Sub-I) is a provider who can see the participants, supervised by the Investigator, at a trial site and is allowed to perform critical trial-related procedures and make related decisions.
