This is about basic terminologies in Clinical research

2. Title
• The official title of a protocol used to identify a clinical study or a short title written in
language intended for the lay public.
• The title acronym: The acronym or initials used to identify a clinical study (not all studies
have one). For example, the title acronym for the Women's Health Initiative is "WHI.“
• Ref:( https://clinicaltrials.gov/ct2/about-studies/glossary)

3. Protocol
• A study done to answer a question. Other words to describe a protocol are
“research,” “study,” and “experiment.” “Protocol” also refers to the plan that details
what researchers will do during the study.
• Ref: https://www.fda.gov/patients/clinical-trials-what-patients-need-
know/glossary-terms

4. Efficacy
• Indication that the clinical trial intervention produces a desired therapeutic effect on
the disease or condition under investigation.
• Ref:https://www.nia.nih.gov/research/dgcg/nia-glossary-clinical-research-terms)

5. Safety
• Safety is relative freedom from harm. In clinical trials, this refers to an absence of
harmful side effects resulting from use of the product and may be assessed by
laboratory testing of biological samples, special tests and procedures, psychiatric
evaluation, and/or physical examination of subjects.
• Safety Monitoring Plan – A plan that outlines the oversight of a clinical trial
• (Clinical-Trail-Glossary-Terms.pdf)

6. Study start date
• The actual date on which the first participant was enrolled in a clinical study.
The "estimated" study start date is the date that the researchers think will be
the study start date.

7. First posted
• The date on which the study record was first available on ClinicalTrials.gov
after National Library of Medicine (NLM) quality control (QC) review has
concluded. There is typically a delay of a few days between the date the study
sponsor or investigator submitted the study record and the first posted date.
• ( https://clinicaltrials.gov/ct2/about-studies/glossary)

8. First submitted
• The date on which the study sponsor or investigator first submitted a study record
to ClinicalTrials.gov. There is typically a delay of a few days between the first
submitted date and the record's availability on ClinicalTrials.gov (the first posted
date).
• (https://clinicaltrials.gov/ct2/about-studies/glossary)

9. Arm
• A group or subgroup of participants in a clinical trial that receives a specific
intervention/treatment, or no intervention, according to the trial's protocol.

10. Eligibility criteria
• The key requirements that people who want to participate in a clinical study
must meet or the characteristics they must have. Eligibility criteria consist of
both inclusion criteria (which are required for a person to participate in the
study) and exclusion criteria (which prevent a person from participating).
Types of eligibility criteria include whether a study accepts healthy
volunteers, has age or age group requirements, or is limited by sex.
• https://clinicaltrials.gov/ct2/about-studies/glossary

11. Inclusion/exclusion criteria
• Inclusion criteria are the factors that allow someone to participate in a
clinical trial. Exclusion criteria are the factors that prevent someone from
participating in the trial. These factors may include a person’s illness, health
history, past treatment, age, sex, or where he or she lives.
• https://www.fda.gov/patients/clinical-trials-what-patients-need-
know/glossary-terms

12. Healthy volunteer
• In a clinical study, a person who does not have the disorder or disease being
studied. Results from healthy controls are compared to results from the
group being studied.
• https://www.fda.gov/patients/clinical-trials-what-patients-need-
know/glossary-terms

13. Group
• Control group - The group of participants that receives standard treatment or a
placebo. The control group may also be made up of healthy volunteers. Researchers
compare results from the control group with results from the experimental group to
find and learn from any differences.( https://www.fda.gov/patients/clinical-trials-
what-patients-need-know/glossary-terms)
• Experimental group - The group of participants in a study that receive the
experimental or study intervention (such as medication or psychotherapy).(
https://www.fda.gov/patients/clinical-trials-what-patients-need-know/glossary-
terms)

14. Placebo
• An inactive pill. This is sometimes called a “sugar pill.” In some studies,
participants may be assigned to take a placebo rather than the study
medication. Ask the researcher if this is a possibility for the study that
interests you.
• https://www.fda.gov/patients/clinical-trials-what-patients-need-
know/glossary-terms