Acronyms and Abbreviations for Clinical Research You Need to Know
Acronyms and Abbreviations for Clinical Research You Need to Know
If you're new to the field of medical research, you might find yourself bombarded with a multitude of acronyms and abbreviations used in clinical trials. Terms like CRA, CRC, and CRO, or eISF, ePRO, and eTMF, might leave you scratching your head. Don't worry; we've got you covered! In this blog post, we have compiled a list of the most common clinical trial abbreviations and what each one represents.
CFR: Code of Federal Regulations
The CFR encompasses a wide range of regulations, but in the context of clinical trials, the most common reference is to 21 CFR, which pertains to the FDA's regulations.
21 CFR Part 11 is another term you'll likely encounter, outlining the FDA's regulations for using electronic documents and signatures during clinical trials.
CRA: Clinical Research Associate
CRA refers to individuals, usually employed by sponsors or CROs (Contract Research Organizations), who perform various tasks, including:
Monitoring study sites either remotely or through in-person visits
Reviewing site documents and data
Updating the eTMF (Electronic Trial Master File)
Assessing site feasibility
Assisting sites with patient recruitment, study start-up, and study close-out
The role of a CRA may vary depending on the sponsor or CRO they work for, and technological advancements have led to changes in the CRA's responsibilities, with remote monitoring becoming more common.
CRC: Clinical Research Coordinator
Also known as a Study Coordinator, a CRC typically works at a research site such as an academic medical center or cancer center. Their duties may include:
Filling out, compiling, or obtaining signatures on regulatory documents
Managing the Investigator Site File (ISF)
Assisting with site recruitment strategies
Explaining the trial to patients
Obtaining informed consent from participants
Conducting meetings with participants and collecting data
Updating logs, such as Delegation of Authority (DOA) logs
Organizing study data and inputting it into various systems
Similar to CRAs, CRCs have witnessed rapid changes in their roles due to technological advancements.
CRO: Contract Research Organization or Clinical Research Organization
A CRO is an organization that helps large sponsors conduct their trials by directly interacting with research sites. As the number of trials grows, sponsors may not be able to oversee every study directly, and this is where CROs play a crucial role. CROs are companies specializing in clinical trials, such as PPD, ICON, or IQVIA.
CTMS: Clinical Trial Management System
A Clinical Trial Management System assists sites, CROs, and sponsors in managing the logistics of clinical trials. Depending on the CTMS, it may perform functions such as:
Scheduling appointments
Organizing participant information, including contact details and study participation
Managing payment information
Tracking study milestones and deadlines
Recording the studies in which a site is participating
Florence's eISF, eBinders™, integrates with several different CTMS systems, including WCG Velos and SignalPath by Verily, and offers an open API for integration with any CTMS that has an open API.
CTR: Clinical Trials Regulation
CTR is a piece of European Union (EU) legislation that came into effect on January 31, 2022. It aims to make the EU an attractive destination for clinical trials while ensuring patient protection and promoting transparency.
DCT: Decentralized Clinical Trial
The term DCT gained popularity after the pandemic and refers to any clinical trial that doesn't take place entirely in person at a research site. DCTs can be fully virtual, with patients submitting all data from home using sensors, wearables, phones, or computers. However, most DCTs are hybrid, with patients occasionally visiting the research site and sometimes utilizing local clinics, pharmacies, and labs for data collection.
DEI: Diversity, Equity, and Inclusion
DEI, sometimes written as D&I (Diversity and Inclusion), represents a broader social movement aimed at ensuring underrepresented groups' inclusion in clinical trials. Efforts are underway by sites, sponsors, CROs, and technology companies to improve the representation of BIPOC, LGBTQ+, older, low-income, and disabled patients in clinical trials.
DOA: Delegation of Authority
DOA is one of several logs that sites must maintain, often done electronically. Some software platforms, like Florence, offer electronic logs and templates for DOA logs.
eCOA: Electronic Clinical Outcome Assessment
eCOA refers to an electronic platform that allows patients, healthcare providers, or caregivers to electronically collect data about how a person feels, functions, or survives during a clinical trial.
EHR: Electronic Health Record
EHR, also known as EMR (Electronic Medical Record), is a platform that stores a patient's health data, including visits to healthcare providers, hospital stays, prescriptions, and participation in clinical trials.
eISF: Electronic Investigator Site File
The Investigator Site File contains a study's essential regulatory documents, and an eISF platform enables sites to store these documents electronically instead of in paper binders. Some sites have also started using eISF to store source data and logs.
EMA: European Medicines Agency
EMA is an agency of the European Union responsible for facilitating the development and access to medicines, evaluating applications for marketing authorization, monitoring the safety of medicines throughout their lifecycle, and providing information to healthcare professionals and patients. It is analogous to the FDA in the US, with the difference that individual EU countries also have their own regulatory agencies.
ePRO: Electronic Patient-Reported Outcome
ePRO is an electronic platform that allows patients to share data about how they feel or function during a clinical trial.
eTMF: Electronic Trial Master File
The Trial Master File contains all essential regulatory documents and data required for a clinical trial. An eTMF is an electronic platform that organizes this information for presentation to regulatory agencies.
FDA: Food and Drug Administration
The FDA is a US organization responsible for ensuring the safety and efficacy of human and veterinary drugs, biological products, and medical devices. Any new medication authorized in the US must first go through the FDA approval process.
GCP: Good Clinical Practice
GCP comprises international standards for designing and conducting ethical and effective clinical trials. Regulatory agencies, including the FDA and EMA, draw inspiration from ICH GCP guidelines.
GDPR: General Data Protection Regulation
GDPR is an EU law that governs how organizations can handle individuals' personal data. Some of its regulations impact patient data used in clinical trials.
GMP: Good Manufacturing Practice
GMP sets the minimum standard that a medicine's manufacturer must meet in their production processes, as defined by the EMA.
HIPAA: Health Insurance Portability and Accountability Act
HIPAA is a US law that governs the protection of personal health data. It applies to a wide range of patient data and often comes into play during clinical trials.
ICH: International Council for Harmonisation
ICH is an organization made up of scientists from multiple countries. It issues Good Clinical Practice recommendations, which serve as the basis for many clinical trial regulations.
IIT: Investigator-Initiated Trial
An IIT is a trial run by an investigator rather than a pharmaceutical or biotech sponsor. IITs are often funded by grants, and the investigator is responsible for maintaining the eTMF.
IRB: Institutional Review Board
The IRB is a designated group responsible for reviewing and monitoring biomedical research involving human participants to protect their rights and welfare.
PHI: Protected Health Information
PHI refers to "individually identifiable health information" under HIPAA, requiring extra security and privacy protections when collected during clinical trials.
PI: Principal Investigator
The PI is the physician responsible for managing and ensuring the integrity of a clinical trial at a specific site.
SOP: Standard Operating Procedures
SOPs are step-by-step instructions used to guide staff in performing specific tasks, playing a critical role in maintaining regulatory compliance in clinical trials.
Frequently Asked Questions
Here are answers to some frequently asked questions about clinical trial abbreviations:
SC stands for Study Coordinator, which has been largely replaced by CRC (Clinical Research Coordinator).
CCT stands for Controlled Clinical Trial, involving a comparison/control group.
CLS stands for Clinical Laboratory Scientist or Medical Laboratory Scientist.
IRB refers to an Institutional Review Board responsible for overseeing biomedical research with human participants.
Conclusion
Familiarizing yourself with the acronyms and abbreviations used in clinical research can be overwhelming at first. However, armed with this comprehensive list, you'll be well-prepared to navigate conversations with seasoned research professionals. Don't hesitate to refer back to this resource whenever you come across an unfamiliar clinical trial abbreviation. And, as always, if you have any questions or need further assistance, feel free to reach out to us on LinkedIn. Happy learning!
