- 臨床試験 (FDA 定義): Clinical investigation means any experiment that involves a test article and one or more human subjects and that either is the subject to requirements for prior submission to the Food and Drug Administration or is not subject to requirements for prior submission to the FDA but the results of which are intended to be submitted later to, or held for inspection by the FDA as part of an application for research or marketing permit.
- 臨床試験実施計画書: Documentation that describes the background, rationale, objectives, design, methodology, statistical considerations and organization of a clinical research project.
- 介入試験 Intervention trial: 候補となる医薬品、治療法、実験的治療法の安全性と有効性のテスト
- 観察研究 Observational trial: No drug/treatment testing. Researchers will monitor participants' health over a period of time.
- Monitor: Sponsor (See Sponsor definition in EDC interface and Veeva Terminology)
- 被験者 Subject: 臨床試験参加者。
- Visit: An event usually where the subject physically goes to the trial location.
EDC Interface and Veeva Terminology:
- Adverse Event (See Also "Serious Adverse Event"): Any untoward medical occurrence in a patient or clinical investigation subject who had a pharmaceutical product administered. These occurrences do not necessarily have a causal relationship with this treatment.
- Breadcrumb: The breadcrumb is the list of hyperlinks a user sees at the top of certain page in EDC. These links may vary but they are links to other relevant sections of the study (such as Subject page, visits, forms etc..). This feature enables easy navigation of the platform.
- Casebook: A detailed report of the diagnosis, treatment, and follow-up of an individual patient. Case reports also contain some demographic information about the patient (for example, age, gender, ethnic origin..).
- Event: 来院日 (See definition in Clinical Trial Terminology)
- Form: Forms are where the data collected is entered in EDC. The form structure and content varies from study to study based on the requirements of the studies.
- Freezing a form: Means of preserving data in its current state. Typically, it occurs before or after data review activities are complete. Frozen data cannot be modified, but all other activities like Source Data Verification can still occur.
- Item: フィールド
- Locking a form: Means of preserving data in its current state. Typically, it occurs before or after data review activities are complete. Locked data cannot be modified and no other activities can occur on the data.
- Serious Adverse Event: An adverse event or suspected adverse reaction is considered "serious" if, in the view of the investigator or sponsor, it results in any of the following outcomes: Death, life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/Birth defect.
- Signature: Usually performed by the investigator as a means of affirming some action in the study
- Site: Physical location where data is collected from the subject (This can be a clinic or hospital..)
- Source Data Verification (SDV): This the process in EDC whereby the user with the sponsor role compares the data collected with the data entered in EDC for accuracy.
- User query/ Auto query: Query that is manually added to a form by a user/ Query that is prompted on a form by the system. Auto query appears if a data entered does not fit within the specified requirements (The age of the subject may fall outside of the age range for a particular study for example).
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