Table 1 Glossary of terms
From: Clinical trial registration and reporting: a survey of academic organizations in the United States
Term | Definition |
|---|---|
Application programming interface (API) | A set of methods to facilitate communication among software components, as described in Section 10 of the PRS User’s Guide (https://prsinfo.clinicaltrials.gov/prs-users-guide.html#section10) |
Cancer center | An organization that specializes in the diagnosis and treatment of cancer, including organizations designated by the National Cancer Institute (see “National Cancer Institute cancer center”) |
Clinical trial (“trial”) | A study in which human participants are assigned prospectively to receive one or more interventions (i.e., diagnostic, therapeutic, or other types) to evaluate the effects of the intervention(s) on health-related outcomes. For example, see [34, 36] |
Clinical and Translational Science Awards (CTSA) | Awards funded by the National Center for Advancing Translational Sciences (NCATS), a part of the National Institutes of Health (NIH), to support a consortium of 64 medical research organizations (https://ncats.nih.gov/ctsa) |
Food and Drug Administration Amendments Act of 2007 (FDAAA) | US Public Law 110-85, which established clinical trial registration and reporting requirements (section 801) [31]. |
Institutional review board (IRB) | A group of persons with responsibility for ensuring the protection of human subjects involved in research. For example, see [58,59,60] |
Investigator | |
National Cancer Institute cancer center (NCI cancer center) | One of 69 organizations designated by the National Cancer Institute (NCI) that specialize in the diagnosis and treatment of cancer (https://www.cancer.gov/research/nci-role/cancer-centers) |
Protocol Registration and Results System (PRS) | A web-based data entry system used to register studies on ClinicalTrials.gov and to submit results for registered studies |
PRS organization account (“account”) | An account assigned to an organization and used to enter information about clinical trials in the Protocol Registration and Results System. An organization account may be managed by one or more administrators and may include trials conducted by multiple investigators |
PRS administrator (“administrator”) | A person who manages an organization account in the Protocol Registration and Results System. Administrators are able to create accounts for individual investigators, review trial information, modify permissions for editing trial information, and check for problems |
Trial registration (registration) | The process of entering a minimum dataset about a clinical trial in registry that is accessible to the public (e.g., ClinicalTrials.gov) [34, 36]. |
Responsible party | The person or entity responsible for submitting information about a clinical study to ClinicalTrials.gov and updating that information [34, 36]. |
Results | Summary information about intervention effects, including participant flow, outcome measures, and adverse events [34, 36]. |
Sponsor | The person or organization who oversees a clinical trial and is responsible for study data [34, 36]. |
The Final Rule (42 CFR 11) | A federal regulation that implements Section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) and expands requirements for trial registration and results reporting. The effective date is January 18, 2017 and the compliance date is April 18, 2017 [34]. |
University/organization | A “type of organization” used to classify PRS organization accounts by www.ClinicalTrials.gov. |