An essential document that records all individuals who entered the screening process. The screening log demonstrates the investigator’s attempt to enroll a representative sample of participants.
A process designed to determine individual’s eligibility for participation in a clinical research study.
Secondary data is data collected by someone other than the user. Common sources of secondary data for social science include censuses, surveys, organizational records and data collected through qualitative methodologies or qualitative research. Primary data, by contrast, are collected by the…
Any adverse event that:Results in death Is life threatening, or places the participant at immediate risk of death from the event as it occurred Requires or prolongs hospitalization Causes persistent or significant disability or incapacity Results in congenital anomalies or birth…
An act or omission to act that resulted in significant harm (physical, psychological, safety, or privacy) or significantly increased the possibility of harm to the rights and welfare of research participants.
A group of participants that receives a procedure or device that is made to be indistinguishable from the actual procedure or device being studied but does not contain active processes or components.
Original documents, data, and records (e.g., written assignments, surveys, hospital records, clinical and office charts, laboratory notes, memoranda, participant diaries, recorded data from automated instruments, x-rays, etc.) that are used in a research study.
An individual who both initiates and actually conducts - alone or with others - a clinical investigation. Corporations, agencies, or other institutions do not qualify as Sponsor-Investigators.
Detailed written instructions to achieve uniformity of the performance of a specific function across studies and patients at an individual site.
Established safety criteria that would either pause or halt a study due to reasons including but not limited to futility or risk(s) to the participants.
Separation of a study cohort into subgroups or strata according to specific characteristics such as age, gender, etc., so that factors which might affect the outcome of the study, can be taken into account.
An individual that handles the administrative and day-to-day responsibilities of a study and acts as a liaison for the site, if applicable. This person may collect the data or review it before it is entered into a study database.