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Compliance In Focus
Posted by Brandy Chittester on Tue, May 7, 2019

30 Clinical Research Trial Acronyms You Need To Know

Making sense of the many clinical research trial acronyms sometimes feels like swimming in alphabet soup.

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After you've been in the field for some time, using these abbreviations often becomes second nature. But for those who are new to this industry, understanding these clinical research acronyms can seem daunting. 

If you need help decoding them, we're here to help. Here are 30 acronyms commonly used in clinical research and what they mean. 

 

Clinical Research Trial Acronyms: A Short Story

If you've been involved in clinical research at all, you might know more than you realize. 

How many clinical research trial acronyms do you recognize in this short story? 

A CRA was hired for a CRO.  During training, the CRA learned the CFR, which included information about the ICF, FDF, IRB, IDE and IND. The CRA was monitoring for IDEs and INDs, so they could be submitted as PMAs and NDAs. 

During the course of his monitoring visits, he reviewed CRFs in EDCs and posted queries about AEs and SAEs.  He worked with PIs and CRCs to review findings. When he had questions, he reached out to his CPM, or his FCE, depending on the nature of the discrepancy. After writing his IMV reports, they went to the CPM for QC, before being finalized and filed in the TMF.

One of his sites was called by the FDA, and he walked them through the BIMO checklist. He hoped they wouldn’t get a WL or even a 483.  He knew he’d taught them GCP from Day 1 and as long as they followed the standards, they would fare well.

The site had no findings and thanked the CRA for all the help with GCP and the CFR. The CRA and the sponsor knew that following RBM set them up for success, and they continued with the same MP for the rest of the study.  The end.

30 Common Clinical Research Acronyms Explained

Confused yet? Here's an explanation of each of the clinical research acronyms in alphabetical order. 

AE - Adverse Event - According to the FDA, the definition of an adverse event is any undesirable experience associated with the use of a medical product in a patient. Adverse events must be reported to the FDA when they result in a serious medical event (see serious adverse event, or SAE). 

BIMO - Bioresearch Monitoring Program - The Bioresearch Monitoring Program (BIMO) is the framework the Food and Drug Administration (FDA) uses to ensure the protection of research subjects and the integrity of clinical research data. The BIMO guidance manual gives clinical researchers instructions to follow to ensure compliance. 

CPM - Clinical Project Manager - The clinical project manager oversees all aspects of a clinical trial, including day-to-day operations, relationships with vendors and data collection and reporting. 

CRA - Clinical Research Associate - A clinical research associate ensures all site activities comply with the clinical trial protocol. CRAs may work directly with the study sponsor, as an independent contractor or as part of a contract research organization (CRO).  They are required to have working knowledge of Good Clinical Practice (GCP) and may or may not have formal training. CRAs may be certified through the Society of Clinical Research Associates (SOCRA) or the Association of Clinical Research Professionals (ACRP). 

CRC - Clinical Research Coordinator - Like a CRA, a clinical research coordinator or study coordinator is responsible for conducting clinical trials and managing the day-to-day activities. So what's the difference between a CRA and a CRC? A clinical research coordinator is typically an entry-level position, while a CRA has more education and experience. Coordinators work directly with the principal investigator (PI) or the research clinic. Their responsibilities include scheduling and conducting study visits. CRCs are not required to have a bachelor's degree, although many have one. CRAs are required to have at least a bachelor's degree and typically a year or two of experience in the field.

CRO - Contract Research Organization - A contract research organization (CRO) is a team of clinical research professionals that offer independent, third-party oversight to sponsors during their clinical research trials. A CRO can assist with monitoring, auditing, project management and more, helping to ensure compliance and keep clinical trials on track. 

CFR - Code of Federal Regulations - The Code of Federal Regulations (CFR) 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, including:

  1. 21 CFR Part 812 (Investigational Device Exemptions) 
  2. 21 CFR Part 312 (Investigational New Drug Application)
  3. 21 CFR Part 50 (Informed Consent) 
  4. 21 CFR Part 56 (Institutional Review Boards) 
  5. 21 CFR Part 54 (Financial Disclosure by Clinical Investigators)
  6. 21 CFR Part 11 (Electronic Records and Electronic Signatures 

CRF - Case Report Form - A case report form is a paper or electronic questionnaire used in clinical trial research to collect dates from participants. 

EDC - Electronic Data Capture - Electronic data capture refers to the method by which clinical research professionals gather data via a digital platform. An EDC platform assists with data management, allowing researchers to collect, enter, review and analyze data remotely, which can help sponsors bring devices to market faster.

FCE - Field Clinical Engineer - A field clinical engineer is someone who develops equipment used to diagnose and treat patients. Clinical engineers typically have a degree in mechanical engineering, biomedical engineering or a related field.

FDA - Food and Drug Administration - The U.S. Food and Drug Administration (FDA) is the agency responsible for regulating all drugs and medical devices in the United States. It conducts site inspections, reviews data collected in clinical trials and ultimately determines whether drugs and devices are approved to go to market. 

FDF - Financial Disclosure Form - A financial disclosure form, sometimes referred to as FDF 3455, discloses any financial relationship or financial interests between the sponsor of the covered study and the study in accordance with 21 CFR 54. 

Form 483 - Inspectional Findings - An FDA Form 483 may be issued following a site inspection to note possible violations. Unlike an FDA Warning Letter, it is not published on the FDA website and does not require a written response, although a written response is encouraged. Learn more about the differences between a Form 483 and an FDA Warning Letter.  

GCP - Good Clinical Practice - Good Clinical Practice (GCP) is a foundation for all clinical research. This set of guiding principles ensures everyone who participates in clinical studies receives the protection they deserve. The fundamental principles of GCP have not changed since they were introduced more than 50 years ago. However, as the use of technology in clinical research has evolved to include electronic signatures, records and more, there are new considerations. Learn more about recent updates to GCP and how to apply them. 

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ICF - Informed Consent Form - An informed consent form (ICF) 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. The Principal Investigator (PI) is responsible for developing an ICF, although there are informed consent templates available for reference. Learn more about informed consent guidelines in clinical research. 

IDE - Investigational Device Exemption - An investigational device exemption (IDE) allows a device 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 - 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 - The FDA's Investigational New Drug (IND) 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 - The Institutional Review Board (IRB) oversees ongoing clinical research to ensure that the rights and welfare of human subjects are protected. The composition, operation and responsibilities of IRBs are outlined in 21 CFR 56.

IVDR - In Vitro Diagnostic Regulation - The IVDR is one of two new requirements governing medical devices marketed in the European Union, along with the MDR (noted below). All medical device companies doing business in the EU must ensure their devices comply with IVDR by 2022. 

MDR - Medical Device Regulation - The medical device regulation (MDR) is a set of new requirements governing medical devices marketed in the European Union. MDR aims to provide greater patient protection with more stringent requirements for clinical evidence, greater transparency and closing loopholes for devices that were previously grandfathered in. All medical device companies doing business in the EU must ensure their devices comply with MDR by 2020. Medical devices already on the market will need to be re-certified under the new regulations. 

MP - Monitoring Plan - A 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. 

NDA - New Drug Application - A new drug application is a formal proposal requesting the FDA to approve a new pharmaceutical drug for sales and marketing.

PI - Principal Investigator - A principal investigator (PI) is the primary person responsible for conducting and supervising clinical research involving human subjects. The role and responsibilities of the principal investigator are outlined in detail in 21 CFR 812

PMA - Premarket Approval - Premarket approval (PMA) 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 - The International Conference on Harmonisation (ICH) offers detailed guidelines for ensuring quality and safety during clinical trials. A quality check is an important part of overall quality management

RBM - Risk Based Monitoring - Risk-based monitoring (RBM) 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 - A serious adverse event is any reaction that results in a life-threatening injury, hospitalization, birth defect, disability or permanent damage or death. 

TMF - Trial Master File - A Trial Master File (TMF) is a comprehensive body of documents related to a clinical trial. The FDA reviews these documents to evaluate the extent to which the trial was well controlled, protected patients and ensured data integrity. A Trial Master File review by an independent auditor can prepare for an FDA audit. This can even be done remotely (via an electronic Trial Master File review) to save time and money. 

WL - Warning Letter - An FDA 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. 

Making Sense of It All

With so many clinical research trial acronyms and regulations to know, this industry can be intimidating even to the most experienced veterans. 

But don't get discouraged! IMARC offers clinical research training to introduce you to the fundamentals of Good Clinical Practice, FDA regulations and more. We also have role-based courses, team training and continuing education that can help you take the next step in your career. 

Our courses are available in person or online, so you can take them at your convenience. To start making sense of all these acronyms and the regulations behind them, download a copy of our course catalog ASAP!  

IMARC University Course Catalog

 

 

 

Topics: Clinical Research, Clinical Monitoring, Acronyms

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