by Lou Ann Donovan
Are you searching for an MPN clinical trial and wondering what all these acronyms and abbreviations listed in the trial study details mean? Well, you are probably familiar with the acronym FDA which is for the Food and Drug Administration. Or maybe you have seen the term QC for Quality Check. Years ago, no one used acronyms in medicine. Then, over time the shortened acronyms helped to simplify communication, facilitate recall, and save space in manuscripts
AE – Adverse Event is any undesirable experience associated with the use of a medical product in a patient and must be reported to the FDA.
BLA – Biologics License Application is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce.
CFR – Code of Federal Regulations is a set of rules published by federal government agencies, including the FDA. Specific titles within the CFR apply to Good Clinical Practice within clinical research.
CPM – Clinical Project Manager oversees all aspects of a clinical trial.
CRA – Clinical Research Associate ensures all site activities comply with the clinical trial protocol.
CRC – Clinical Research Coordinator or study coordinator is an entry-level position responsible for conducting clinical trials and managing the day-to-day activities.
CRF – Case Report Form is a paper or electronic questionnaire used in clinical trial research to collect dates from participants.
DLT – Dose Limiting Toxicity is defined to be a toxicity that prevents further administration of the agent at that dose level.
FDA – Food and Drug Administration is the agency responsible for regulating all drugs and medical devices in the United States. It reviews data collected in clinical trials and ultimately determines whether drugs and devices are approved to go to market.
Form 483 – Inspectional Findings is an FDA Form 483 that may be issued following a site inspection to note possible violations. It is not published on the FDA website and does not require a written response, although it is encouraged.
GCP – Good Clinical Practice is a foundation for all clinical research. This set of guiding principles ensures everyone who participants in clinical studies receives the protection they deserve.
ICF – Informed Consent Form is used to ensure everyone involved in clinical research is a willing participant with full knowledge of the potential risks and benefits to the extent that this is possible.
IDE – Investigational Device Exemption allows a devise that has not been cleared for marketing to be used in a clinical study to collect safety and effectiveness data. All clinical evaluations of investigational devices unless exempt, must have an approved IDE before the study is initiated.
IMV – Interim Monitoring Visits are an important part of clinical research monitoring. These visits occur periodically throughout the clinical trial according to the monitoring plan.
IND – Investigational New Drug program is the means by which a pharmaceutical company obtains permission to start clinical trials and ship an experimental drug across state lines before a marketing application for the drug has been approved.
IRB – Institutional Review Board oversees ongoing clinical trial research to ensure that the rights and welfare of human subjects are protected.
MP – Monitoring Plan outlines the protocol for monitoring a specific clinical trial, including how often monitoring visits will occur and what must be documented in monitoring visits.
MPN-SAF TSS the Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score is a validated tool for measurement of symptoms for patients. The MPN-SAF includes 14 disease related symptoms scored from 0 (absent) to 10 (worst imaginable) and is used to calculate a total symptoms score (TSS; sum of 14 individual symptom scores).
NDA – New Drug Application is a formal proposal requesting the FDA to approve a new pharmaceutical drug for sales and marketing.
OD – Orphan Drug is intended for the treatment, prevention or diagnosis of a rare disease or condition that affects less than 200,000 people in the United States.
PI – Principal Investigator is the primary person responsible for conducting and supervising clinical research involving human subjects.
PMA – Premarket Approval is the FDA process of evaluating the safety and effectiveness of Class III medical devices – those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential unreasonable risk of illness or injury.
QC – Quality Check is an important part of overall quantity management. The International Conference on Harmonisation (ICH) offers detailed guidelines for ensuring quality and safety during clinical trials.
RBM – Risk Based Monitoring is an approach that takes into consideration the potential risks of a trial when determining what monitoring activities are necessary and how they should be performed.
SAE – Serious Adverse Event is any reaction that results in a life-threatening injury, hospitalization, birth defect, disability or permanent damage or death.
SC – Subcutaneous means under the skin injection as a method to administer the drug.
WL – Warning Letter may result after a Form 483, indicating that higher FDA officials have reviewed the observations from an investigation and that a serious violation may exist. This formal notification requires a written response, typically within 15 days.
Click here to learn more about the phases of clinical trials. Before participating in a clinical trial, talk to your health care provider and learn more about the potential benefits and risks for your specific MPN diagnosis.
This article is sponsored by Bristol Myers Squibb. MPN Cancer Connection has complete independence in content creation.