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- BESH
- Basic Experimental Studies Involving Humans
- Studies that meet both the US federal definition of basic research and the NIH definition of a clinical trial
- Casper
- Computer-Based Assessment for Sampling Personal Characteristics
- Admissions test at medical schools worldwide
- CRF
- Case Report Form
- Structured forms used to record and report specific data in clinical trials
- CTMS
- Clinical Trial Management System
- Specific software systems used to manage clinical trials and their data
- eCTD
- Electronic Common Technical Document
- The eCTD is the standard format for submitting applications, amendments, supplements, and reports to FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) [1]
- EHR
- Electronic health records
- Digital versions of a patient's paper chart
- NOL
- No Objection Letter
- Official documentation that the CTA has been reviewed by Health Canada [2]
- NSN
- Not Satisfactory Notice
- Official document issued by Health Canada if significant deficiencies are identified during the review of the clinical trial application [2]
- OHRP
- Office for Human Research Protections
- OHRP provides leadership in the protection of the rights, welfare, and well-being of human subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS). Website: https://www.hhs.gov/ohrp/index.html
- PROs
- Patient-reported outcomes
- Data collected directly from patients regarding their health status and quality of life
- SAE
- Serious adverse event
- Significant incident during a course of a clinical trial that meets specific medical and administrative criteria, such as being life-threatening or requiring hospitalization.
See also
Another relevant pages
Links to this page
References
- ↑ FDA, 2024, eCTD Resources https://www.fda.gov/drugs/electronic-regulatory-submission-and-review/ectd-resources Accessed Jun 2025
- ↑ 2.0 2.1 Health-Canada, 2016, Guidance Document For Clinical Trial Sponsors: Clinical Trial Applications https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/clinical-trials/clinical-trial-sponsors-applications.html#a252 Accessed May 2024
External links
- NIH, 2022, National Institutes of Health Glossary, https://grants.nih.gov/grants/glossary.htm Accessed May 2024
- EMA, Glossary of regulatory terms, https://www.ema.europa.eu/en/about-us/glossaries/glossary-regulatory-terms Accessed Jul 2024
- https://www.appliedclinicaltrialsonline.com/view/cdisc-clinical-research-glossary
- https://mrctcenter.org/glossary/
- https://en.wikipedia.org/wiki/Glossary_of_clinical_research