Acronyms and Abbreviations for Clinical Research You Need to Know

There are dozens of abbreviations for clinical trial terms. What’s the difference between a CRA, a CRC, and a CRO? How about the difference between eISF, ePRO, and eTMF?

If you’ve been in medical research for years, these clinical trial abbreviations might come naturally to you–but if you’re just starting out in the industry, the sheer number of acronyms can be overwhelming. 

That’s why we put together a list of the most common abbreviations for clinical research. With this list, you’ll be ready next time you discuss clinical trials with a seasoned research professional.

Common Clinical Trial Abbreviations

Here’s a list of the most commonly used clinical trial abbreviations, what each one stands for, and what the terms mean.

CFR: Code of Federal Regulations

The CFR covers a wide range of regulations, but in the context of clinical trials, you’ll most often hear about 21 CFR, which is reserved for the FDA’s regulations. 

You’ll probably also hear a lot about 21 CFR Part 11. Part 11 describes the FDA’s regulations for using electronic documents and electronic signatures during clinical trials.

CRA: Clinical Research Associate

The CRA acronym refers to people, usually employed by sponsors or CROs, who perform tasks like: 

• Monitoring study sites remotely or through in-person visits
• Reviewing site documents and data
• Updating the eTMF
• Determining site feasibility
• Helping sites with patient recruitment, study start-up and study close-out

A CRA’s job can vary depending on the sponsor or CRO they work for. Technology has also changed the role of a CRA, as remote monitoring becomes more common. 

You can learn about the impact of remote monitoring on CRAs in our benchmark report.

CRC: Clinical Research Coordinator

Sometimes also called a Study Coordinator. A CRC usually works at a research site, like an academic medical center or cancer center. Their duties might include:

• Filling out, compiling, or seeking out signatures on regulatory documents
• Maintaining the Investigator Site File (ISF)
• Helping with site recruitment strategies
• Explaining the trial to patients
• Receiving informed consent from participants
• Meeting with participants and collecting data
• Updating logs, like Delegation of Authority (DOA) logs
• Organizing the study data and inputting it into different systems

Like CRAs, CRCs have seen their jobs change rapidly with the advent of technology. You can learn more about the changing expectations placed upon CRCs in this article.

CRO: Contract Research Organization or Clinical Research Organization

A CRO is an organization that helps large sponsors run their trials by interacting directly with sites. With the rapid growth of trials, sponsors can’t always directly oversee every study they need to conduct. This is an abbreviation for clinical trial companies like PPD, ICON, or IQVIA. 

Want to learn more about how to run a digitally-enabled CRO? Check out this article!

CTMS: Clinical Trial Management System

A Clinical Trial Management System helps sites, CROs, and sponsors with the logistics of clinical trials. Depending on the CTMS, it may perform functions like:

• Scheduling appointments
• Organizing participant information, like contact details and studies they’ve joined
• Maintaining payment information
• Tracking against different study milestones or deadlines
• Recording which studies a site is participating in 

Florence’s eISF, eBinders™, integrates with several different CTMS systems, including WCG Velos and SignalPath by Verily. We also offer an open API that lets us integrate with any CTMS that also has an open API.

CTR: Clinical Trials Regulation

A piece of European Union (EU) legislation that went into effect on 31 January 2022. CTR is supposed to make the EU an attractive destination for clinical trials while protecting patients and encouraging transparency. To learn more about CTR, check out our complete breakdown of the legislation.

DCT: Decentralized Clinical Trial

This clinical trial abbreviation, which exploded in popularity after the pandemic, refers to any clinical trial that doesn’t take place 100% in person at the research site. 

The trial could be fully virtual, with patients submitting all of their data at home from a sensor, wearable, phone, or computer. But most often, DCTs are hybrid, with the patient sometimes submitting data from home and sometimes visiting the research site. Patients might also visit frontier sites like pharmacies, labs, and local clinics in addition to (or instead of) the main research site. 

To learn more about decentralized clinical trials, check out:

• Five Things You Need to Know About Decentralized Clinical Trials Today
• 9 Challenges and Risks for Launching Decentralized Trials
• Top Healthcare Software to Power Decentralized Trials
• 5 Tips for Successful Decentralized Clinical Trials
• What Do Patients Think About Decentralized Clinical Trials?

DEI: Diversity, Equity, and Inclusion

Sometimes also written as D&I (Diversity and Inclusion.) This broader social movement to ensure underrepresented groups are included has created seismic changes in clinical trials. 

Sites, sponsors, CROs, and technology companies are working together to figure out how to improve the representation of BIPOC, LGBTQ+, older, low-income, and disabled patients in clinical trials. 

You can learn more about the underrepresentation of many patients and how we can improve this by building trust, reaching out to local communities, and increasing access. Check out the following articles on DEI: 

• How to Improve Patient Diversity in Clinical Trials
• How Community Sites Can Improve the Lack of Diversity in Clinical Trials
• FDA Guidance for Diversity in Clinical Trials: What You Need to Know
• Medicaid Coverage of Clinical Trials Will Improve Inclusion: But There’s More Work to Do

DOA: Delegation of Authority

One of many logs that sites must maintain. Often created electronically. Some software platforms, like Florence, offer electronic logs and electronic templates for DOA logs.

eCOA: Electronic Clinical Outcome Assessment

The FDA defines a clinical outcome assessment (COA) as a way to describe how a person feels, functions, or survives. 

The data can be collected by a healthcare provider, a patient, or a parent or guardian, and eCOA software lets any of those people collect the data electronically. Well-known eCOA providers include Medidata, Signant, and Castor.

EHR: Electronic Health Record

Also sometimes known as EMR, or Electronic Medical Record. This abbreviation for clinical trial software refers to a platform that stores a patient’s health data, ranging from visits to their primary care doctor to hospital stays, prescriptions, and any clinical trials they may join. Most health systems have their own EHR system they prefer to use.

eISF: Electronic Investigator Site File

The Investigator Site File is maintained by the site and contains a study’s essential regulatory documents. With an eISF platform, sites can store their regulatory documents electronically instead of in paper binders. Some sites have begun storing source data and logs in the eISF as well as regulatory documents. 

To learn more about the role of an eISF, check out:

• Why Sites Must Own the eISF
• Linking to the Site’s eISF: Why It Matters and How to Do It
• Why Sponsors and CROs are Investing in Electronic Investigator Site Files for Their Sites in 2022
• Complete Guide to eISF + Remote Site Access in Clinical Trials

EMA: European Medicines Agency

An agency of the European Union in charge of:

• Facilitating development of and access to medicines
• Evaluating applications for marketing authorization 
• Monitoring the safety of medicines across their lifecycle
• Providing information to healthcare professionals and patients

The EMA is similar to the FDA in the US, which also performs the above functions. However, there is a major difference: within the EU, individual countries also have their own regulatory agencies. These national regulatory agencies evaluate applications for the authorization of clinical trials.

There are also two methods for approving drugs in the EU: the centralized process and the national process. While certain drugs need to go through the centralized process and receive EMA approval, others only go through the national process of their respective country.

ePRO: Electronic Patient-Reported Outcome

An electronic platform that patients use to share data about how they feel or function. Patients can report data from home or work via their computer, their phone, or a wearable. Well-known ePRO vendors include Castor, WCG, and Signant.

eTMF: Electronic Trial Master File

The Trial Master File contains all the essential regulatory documents and data that the sponsor, CRO, or investigator running the trial needs. An eTMF is an electronic platform that keeps all this information organized so it can be presented to regulatory agencies.

To learn more about eTMFs, check out:

• Five Capabilities You Need in an eTMF
• Complete Guide to the Modern Electronic Trial Master File (eTMF) 
• Electronic Trial Master File (eTMF) Capability Checklist
• How to Maximize CRA Efficiency with an eTMF

FDA: Food and Drug Administration

This U.S. organization ensures the safety and efficacy of human and veterinary drugs, biological products, and medical devices. Every new medication authorized in the U.S. must first go through the FDA. If you are curious about the FDA guidelines, check out our library of questions and answers about FDA regulations.

GCP: Good Clinical Practice

Good Clinical Practice is a set of international standards for designing and executing ethical and effective clinical trials. The International Council for Harmonisation (ICH) created the GCP guidelines and many regulatory agencies take inspiration from them, including the FDA and EMA. To learn more about ICH GCP E6(R2), a major part of GCP, see this page.

GDPR: General Data Protection Regulation

A law in the EU that determines what organizations can do with a person’s personal data. Several of the regulations on data protection and privacy impact the patient data used in clinical trials. You can learn more about GDPR in our guide to GDPR and clinical trials.

GMP: Good Manufacturing Practice

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

The law that governs the protection of personal health data in the U.S. Because HIPAA applies to a wide range of patient data, it often comes into play during clinical trials. You can learn more about how HIPAA applies to clinical trial data here.

ICH: International Council for Harmonisation

aka International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. The ICH is made up of scientists from multiple countries and issues Good Clinical Practice recommendations that are used as the basis for many clinical trial regulations.

IIT: Investigator-Initiated Trial

A trial that is run by an investigator instead of by a pharmaceutical or biotech sponsor. IITs are often funded by grants, and they require the investigator to maintain the eTMF. If you’d like to learn more about using an eTMF for IITs, check out our article on investigator-initiated trials.

IRB: Institutional Review Board

This common clinical trial abbreviation refers to a group designated to review and monitor biomedical research with human participants. The IRB can approve, require modifications to, or disapprove a clinical trial. Their job is to look out for the rights and welfare of human participants.

PHI: Protected Health Information

Under HIPAA, PHI refers to any “individually identifiable health information.” This information needs extra security and privacy protections when it’s collected during clinical trials.

PI: Principal Investigator

The PI is the physician responsible for the management and integrity of the clinical trial at a particular site. During an investigator-initiated trial, the PI runs the entire trial. During a sponsor-initiated trial, the physician is in charge of making sure the trial is run correctly, patients are protected, and data is collected accurately at their research site.

SOP: Standard Operating Procedures

SOPs are used to walk staff step-by-step through how to perform a task. In clinical trials, SOPs are very important as they’re used to help maintain regulatory compliance.

As a bonus, here are a few frequently asked questions people have when they begin learning abbreviations for clinical research:

Abbreviations for Clinical Research: Frequently Asked Questions

These are among the most frequently-asked question when people first start learning about clinical trials: 

What does SC stand for in clinical research?

SC stands for Study Coordinator, the person who manages the study at the research site. Though this term is still sometimes used, Clinical Research Coordinator or CRC has quickly  become more common.

What does CCT stand for in medical terms? 

CCT stands for Controlled Clinical Trial, a clinical trial that includes a comparison (control) group. The control group may receive the current standard of treatment, a placebo, or no treatment. The patients who aren’t in the control group receive the experimental treatment. 

What does CLS mean in medical terms? 

CLS stands for Clinical Laboratory Scientist or Medical Laboratory Scientist. A CLS analyzes biological specimens. This scientist can be involved in clinical trials, but their work can also be much broader.

Abbreviations for Clinical Research

Recognizing the many abbreviations used for clinical research can help you feel less overwhelmed when you’re first starting out in the industry. Print out the list of abbreviations or pin it to your desktop for easy access–and let us know about any we missed on LinkedIn!

New to clinical trials and want to learn more? You can check out our guide to the career of a clinical research coordinator.