Miscellaneous
A person with no known significant health problems who participates in clinical research to test a new drug, device, or intervention.
What is a healthy volunteer or control?
This documentation is the responsibility of the person who is obtaining consent and must be completed each and every time a consent form is signed.
What is the consent note?
The person(s) in charge of a clinical trial. They are ultimately responsible for all aspects of the clinical trial. They may also be responsible for analyzing the data and reporting the results of the trial.
Who is the principal investigator?
This is the only anatomical location that a CRC at MGH is allowed to draw blood from.
What is the antecubital fossa/elbow/arm?
This type of tube is recommended for the collection of CSF specimens that will be analyzed for amyloid and tau proteins.
What is polypropylene?
What is clinical research
The process of learning the key facts about a clinical trial before deciding whether to participate. This process of providing information to participants occurs prior to any study procedures and continues throughout the study.
What is informed consent?
This person performs administrative duties related to research practices, works with study participants to schedule study visits and works with the principal investigator and study team to help complete clinical research visits and procedures
Who is the CRC Clinical Research Coordinator?
This tube is used to collect a CBC
What is a lavendar top/purple top/3 ml EDTA?
An ultrafiltrate of plasma contained within the ventricles of the brain and the subarachnoid spaces of the cranium and spine. It performs vital functions, including providing nourishment, waste removal, and protection to the brain.
What is CSF (cerebrospinal fluid)?
An independent committee that consists of physicians, other scientists, and members of the community who ensure that clinical trials are ethical and that the rights of participants are protected.
What is the IRB (Institutional Review Board) or the IEC (Independent Ethics committee)?
Per the IRB policy, the original signed and dated ICF must be kept at the site and should be stored in this location.
What is the subject's source binder?
Healthcare professionals who help to ensure that clinical trials are being conducted appropriately at the site level and that all site processes are in line with the clinical trial protocol, including local and international laws.
What is a CRA (clinical research associate or monitor)?
This blood test is used to evaluate a patient's ability to clot and can be completed at core lab or using the Coaguchek instrument.
What is PT/INR?
This is the most common side effect of having a lumbar puncture.
What is a headache (Low volume headache)
The discovery of a mass lesion in the brain during the conduct of a study related MRI.
What is an incidental finding?
Per the IRB policy, 2 copies of the ICF should be made and stored in these 2 places.
What are uploaded to EPIC and given to the participant?
A person or organization who initiates an investigation, but who does not actually conduct the trial
Who is the sponsor?
This is a fainting episode resulting from certain stressful triggers, such as phlebotomy, which leads to a sudden drop in blood pressure and heart rate.
What is a vasovagal reaction?
These are the most common needle sizes for an Investigator to use when performing an LP.
What are 22G and 24G? (90mm and 120mm)
This phase of clinical research involves hundreds to thousands of study subjects. It collects more data on the safety profile and effectiveness of the drug (including side effects) and often provides the basis for FDA approval.
What is a Phase 3 trial?
This demonstrates that the patient is able to understand the risks and benefits of the research and make a decision about whether or not to participate in the research.
What is capacity to consent?
They are responsible for the management of investigational products including medicines and biologicals but may also manage gene therapy and radiopharmaceuticals.
Who is the clinical trials pharmacist?
This is the lowest serum concentration level of a drug. This type of PK sample should be drawn immediately before the next administration of the investigational product.
What is a trough level?
The patient may be placed into these positions while undergoing a lumbar puncture.
What is sitting, or side lying.