CIMC flashcards
CIMC · Build recall with a focused review session.
32 cards. Read the term and the definition here. The deck at the top of this page is optional.
- Informed Consent
- Ongoing process by which a subject voluntarily confirms willingness to participate after being informed of all relevant aspects of the trial.
- Serious Adverse Event
- Any untoward medical occurrence that results in death, is life-threatening, requires hospitalization, causes disability, or is a congenital anomaly.
- SUSAR
- Suspected Unexpected Serious Adverse Reaction; an adverse event that is serious, unexpected, and has a reasonable possibility of being caused by the investigational product.
- Protocol Deviation
- Any change, divergence, or departure from the study design or procedures defined in the protocol without prior sponsor and IRB approval.
- Source Data Verification
- Process of comparing data in the case report form with original source documents to ensure accuracy and completeness.
- Risk-Based Monitoring
- Monitoring approach that focuses resources on critical data and processes based on assessed risks, rather than 100% source data verification.
- Case Report Form
- Printed, optical, or electronic document designed to record all protocol-required information to be reported to the sponsor.
- Intention-to-Treat
- Analysis that includes all randomized subjects in the groups to which they were assigned, regardless of compliance or withdrawal.
- Database Lock
- Point at which all data have been entered, validated, and queries resolved; no further changes are allowed without formal unlocking.
- Statistical Analysis Plan
- Detailed document describing statistical methods and analyses to be performed, finalized before database lock.
- FDA Form 1572
- Statement of the Investigator, required for IND studies, listing investigator qualifications and study site information.
- ICH GCP
- International Council for Harmonisation Good Clinical Practice; international ethical and scientific quality standard for clinical trials.
- IND Safety Report
- Report submitted to FDA for serious unexpected suspected adverse reactions; 7-day for fatal/life-threatening, 15-day for others.
- IRB/IEC
- Institutional Review Board or Independent Ethics Committee; reviews and approves research involving human subjects to protect their rights and welfare.
- Belmont Report
- Ethical framework for human subjects research based on principles of respect for persons, beneficence, and justice.
- Assent
- Agreement by a minor or cognitively impaired person to participate in research, obtained in addition to parental or guardian permission.
- Site Initiation Visit
- Monitoring visit conducted before site activation to verify site readiness, training, and investigational product accountability.
- Essential Documents
- Documents that individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced.
- Site Activation
- Process of completing all regulatory, contractual, and training requirements before a site can enroll subjects.
- Feasibility Assessment
- Evaluation of a site's ability to conduct a trial, including patient population, staff experience, and competing studies.
- Primary Endpoint
- Pre-specified outcome measure that directly addresses the primary objective of the trial and is used for sample size calculation.
- Adaptive Design
- Trial design that allows pre-planned modifications to trial procedures based on interim data, while controlling type I error.
- RACI Matrix
- Tool that defines roles as Responsible, Accountable, Consulted, or Informed for project tasks and deliverables.
- Delegation Log
- Document that records tasks delegated by the principal investigator to study staff, signed and dated by the investigator.
- SMART Goals
- Goals that are Specific, Measurable, Achievable, Relevant, and Time-bound, used for team and project management.
- Tuckman Stages
- Model of team development: Forming, Storming, Norming, Performing, and Adjourning.
- Per-Patient Budget
- Financial plan that itemizes costs for each subject, including screening, visits, procedures, and overhead.
- Pass-Through Costs
- Expenses billed separately from site service fees, such as IRB fees, central lab tests, and shipping.
- Clinical Trial Agreement
- Contract between sponsor and site defining scope, payment terms, indemnification, and publication rights.
- Financial Disclosure
- Requirement for investigators to disclose financial interests to the sponsor and FDA for certain studies.
- MedDRA
- Medical Dictionary for Regulatory Activities; standardized terminology used for coding adverse events in clinical trials.
- Screen Failure
- Subject who signs informed consent but does not meet eligibility criteria and is not randomized or enrolled.