CIMC key terms

A study document listing each team member and the specific trial tasks they are permitted to perform, signed by the principal investigator and dated. It supports oversight and shows that duties were assigned to qualified personnel.

The qualified person at a trial site who takes overall responsibility for conducting the study there, including protecting subjects, supervising staff, and ensuring protocol and regulatory compliance.

A pre-enrollment meeting where the sponsor or monitor trains site staff, verifies readiness and supplies, and documents that the site can begin the study. It closes the start-up phase.

An international ethical and scientific quality standard for designing, conducting, recording, and reporting trials involving human subjects. It safeguards participants and ensures credible trial data.

An independent committee that reviews and approves or disapproves research involving human subjects. It evaluates risks, benefits, consent documents, and protections before and during the study.

A written document that explains a study's purpose, procedures, risks, benefits, and alternatives, which participants read and sign voluntarily before any study activity. It is approved by the reviewing ethics committee.

Groups whose ability to give voluntary informed consent may be limited, such as children, prisoners, pregnant women, or cognitively impaired adults. They require extra safeguards and justification for inclusion.

The written plan describing a trial's objectives, design, methods, and statistical analysis. It defines eligibility, treatments, assessments, and endpoints and governs how the study is conducted.

The specific characteristics that determine who may or may not enroll in a trial, such as age, diagnosis, or prior therapy. Clear criteria protect participant safety and support interpretable results.

A formal, documented change to an approved protocol, which must be reviewed and approved before implementation except when needed to remove an immediate hazard to subjects.

An evaluation of whether a site or country can recruit the target number of eligible participants within timelines, given its patient pool, staff, facilities, and competing trials. It informs site selection.

A pre-study evaluation where a sponsor assesses a potential site's facilities, staff qualifications, patient population, and experience to decide whether to include it in the trial.

A scheduled on-site or remote review by a sponsor representative to verify protocol compliance, data accuracy against source records, and subject safety, with findings documented in a report.

The process of comparing data entered in the trial database or case report form against original records, such as medical charts, to confirm accuracy and completeness.

A paper or electronic document designed to capture protocol-required data for each participant for submission to the sponsor. It must be accurate, complete, and consistent with source records.

The process by which a site investigates and answers a data discrepancy raised by the sponsor or data manager, with documentation of the correction or clarification in the trial database.

A request for explanation or correction of inconsistent, missing, or implausible data in a trial database. It is tracked to closure to ensure data quality before analysis.

An adverse event that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, causes persistent disability, or is a congenital anomaly. It requires expedited reporting.

Any unfavorable medical occurrence in a trial participant, whether or not considered related to the investigational product. Investigators must record and assess all such events.

The investigator's judgment about whether an adverse event is related to the investigational product, typically graded as related, possibly related, unlikely related, or unrelated, using temporal and clinical evidence.

A time-sensitive notification of a serious, unexpected suspected adverse reaction sent to regulators and ethics committees within defined timelines, often seven or fifteen calendar days.

The process of agreeing on the costs a sponsor will pay a site for study activities, including per-patient fees, startup costs, and overhead, documented in a finalized budget.

A contract between a sponsor and a site or institution setting out obligations, payment terms, confidentiality, publication rights, indemnification, and intellectual property related to the study.

A payment to a site for each enrolled participant who completes specified study visits or procedures, used to align compensation with actual work performed.

An expense incurred by a site that is billed to the sponsor at actual cost rather than as a fixed fee, such as imaging, laboratory tests, or shipping.

A method of assigning participants to treatment groups by chance to reduce bias and balance known and unknown prognostic factors across arms.

A design feature that conceals treatment assignment from participants, investigators, assessors, or analysts to prevent bias in reporting and evaluation of outcomes.

A document finalized before database lock that specifies the statistical methods, analysis populations, and handling of missing data for the trial, ensuring pre-specified and reproducible analyses.

The analysis set that includes all randomized participants analyzed according to their assigned group, regardless of compliance, preserving the benefits of randomization.

The formal point at which the trial database is frozen and no further changes are permitted, typically after all queries are resolved, enabling unblinding and analysis.

The documented tracking of study drug receipt, dispensing, return, and destruction at a site to confirm that participants received correct doses and that quantities reconcile.

Records that individually and collectively permit evaluation of a trial's conduct and data quality, including approvals, consent forms, training records, and monitoring reports, retained for inspection.

The package of documents filed with a national authority to obtain permission to conduct a trial or market a product, including the protocol, investigator brochure, and manufacturing information.

A compilation of clinical and nonclinical data on an investigational product relevant to its study in humans, provided to investigators to support safe trial conduct.

A secure, computer-generated record that captures who created, modified, or deleted electronic data and when, preserving data integrity for regulatory inspection.

The final monitoring activity confirming that all outstanding issues are resolved, investigational product and records are accounted for, and the site's participation is formally concluded.