Glossary
ACIB: Costa Rican Agency for Biomedical Research.
Addendum: It is a modification/addition to the original protocol or informed consent.
ACAI: Informed Consent/Assent Administrator.
Randomization: Process of randomizing treatment to participants in order to reduce selection bias.
AI: Informed Assent.
ASO4: ASO4 adjuvant system (Monophosphoryl lipid A and Aluminum phosphate).
Biorepository: Is a repository for biological materials that collects, processes, stores, and distributes biological samples to support future scientific research.
Doble blind: In a double-blind clinical trial, the participating individuals and the investigators are unaware of the treatment administered. The double-blind method is a tool that is used to prevent the results of an investigation from being influenced by bias, that is, by the tendency that the participating people might have to act differently or perceive things differently if they know which treatment they received or researchers observing or following people in a different manner because of the different treatments they received, based on their own judgments.
CD: Document Center.
CEC: Ethical-Scientific Committee.
CI: Informed Consent.
CONIS: National Health Research Council of the Ministry of Health, Costa Rica.
CVT: Costa Rica HPV Vaccine Trial.
ESCUDDO: Comparative Study of One and Two Doses of HPV Vaccine.
EVI: Independent Vaccination Team.
FDA: Food and Drug Administration.
Participant: Term used throughout the protocol to denote an individual who has been contacted to voluntarily participate in the clinical study, either as a recipient of the candidate or control regimens, or as a participant in the Epidemiology Survey.
Potential Participant: Potential participant with registration prior to their eligibility.
Recruiting participant: Participant who signed CI/AI, as applicable.
PEG: Guanacaste Epidemiological Project.
PID: Participant ID.
Protocol: Describes the objectives, design, methodology and considerations taken into account for the implementation and organization of the study. It includes the design of the procedures to be used for the observation, analysis and interpretation of the results. Incluye el diseño de los procedimientos a ser utilizados para la observación, análisis e interpretación de los resultados.
Deviation from protocol: A protocol deviation/violation is generally an unplanned exclusion from the protocol that is not implemented or intended to be a systematic change. Protocol deviation is also used to refer to any other unplanned instance of protocol non-compliance.
SAE: Serious Adverse Event.
Passive follow-up: Follow-up that can be carried out on files or participant data.
Branch: physical location, where there is a biorepository annex.
TDAP/Adacel®: Vaccine against Diphtheria Tetanus and Pertussis.
Cérvarix®: Vaccine against HPV (Bivalent), protects against 16 and 18, and partially against other types of HPV.
TI: Information technology.
Legal guardian: Legal representative of an underage.
UGM: Minimum Geostatistical Unit.
Window: It refers to a period covered within an appointment system in a research study, ranging from the opening of the windows to recruitment visits, and follow-up, ideal date of visit, critical periods (last possible date), and closing of window.
VPH: Human papillomavirus.
FUNIN: Fundación INCIENSA
GAM: Gran Área Metropolitana
GARDASIL®: Vacuna contra el VPH (Tetravalente), protege contra el 16, 18, 6, 11
Gardasil9®: Vacuna contra el VPH (Nonavalente), protege contra el 16, 18, 6, 11, 31, 33, 45, 52, 58.
GEE: Grupo Encuesta Epidemiológica (En inglés Survey), conocido también como EPI.
ICIC: Instituto Costarricense de Investigaciones Clínicas
INTRANET: Red interna de nuestra organización.
LTFU: Estudio de Seguimiento a Largo Plazo (por sus siglas en ingles “Long Term Follow-Up”)
MOOP: Manual de Operaciones del Estudio
NCI: Instituto Nacional del Cáncer (por sus siglas en inglés “National Cancer Institute”)
NIH: Institutos Nacionales de Salud (por sus siglas en inglés “National Institutes of Health”)
OW: Trabajador de Campo (por sus siglas en inglés “Outreach worker”)
