ACRP-CP key terms

The outcome measure defined in the protocol before data collection that addresses the trial's main question and typically drives the sample size and statistical analysis plan.

Assignment of participants to treatment groups by chance rather than by investigator or participant choice, which helps balance known and unknown confounders and reduces selection bias.

The probability that a trial will detect a true effect of a given size if that effect exists; conventionally set at 80% or 90% when planning sample size.

An analysis that includes all randomized participants in the groups to which they were assigned, regardless of whether they received treatment or later deviated from the protocol.

A study designed to show that an experimental treatment is not worse than an active comparator by more than a pre-specified margin, often used when a placebo control would be unethical.

A trial design that permits prospectively planned changes to aspects such as sample size, treatment arms, or endpoints based on interim data, while preserving statistical validity and trial integrity.

A situation in which an outside factor is associated with both the exposure and the outcome, distorting the observed relationship unless it is controlled through study design or analysis.

An ongoing process in which a prospective participant voluntarily agrees to join research after receiving and understanding information about its purpose, procedures, risks, benefits, and alternatives.

An independent committee that reviews research involving human participants and has authority to approve, require modification of, or disapprove studies in order to protect participants' rights and welfare.

Groups whose ability to give voluntary informed consent may be limited or who face elevated risk of harm, such as children, prisoners, or cognitively impaired adults, requiring additional safeguards.

A participant's mistaken belief that research procedures are designed to benefit them personally rather than to produce generalizable knowledge, which can undermine the validity of consent.

Agreement by a minor or person with impaired decision-making capacity to take part in research, obtained alongside permission from a legally authorized representative using language suited to the person's understanding.

Any untoward medical occurrence in a participant given an investigational product, whether or not considered related to it, including abnormal laboratory findings or worsening of an existing condition.

An adverse event that causes death, is life-threatening, requires or prolongs hospitalization, causes persistent disability, is a congenital anomaly, or needs intervention to prevent one of these outcomes.

A suspected unexpected serious adverse reaction: a serious adverse event judged possibly related to the investigational product whose nature or severity is not consistent with the reference safety information.

An independent committee that periodically reviews accumulating safety and efficacy data and recommends whether a trial should continue, be modified, or be stopped.

A large, often randomized and controlled study that confirms efficacy, assesses safety, and compares benefits and risks in the target population, typically providing the main evidence for marketing approval.

A compilation of clinical and nonclinical information about an investigational product, prepared by the sponsor and given to investigators and review boards to support safe trial conduct.

A pharmaceutical form of an active ingredient or placebo that is being tested or used as a reference in a trial, including an approved product studied for a new use.

Regulatory approval allowing a medicine to be sold for specified indications in a jurisdiction, granted after review of evidence for quality, safety, and efficacy.

An international ethical and scientific quality standard for designing, conducting, recording, and reporting trials with human participants, ensuring data credibility and protection of participants' rights.

A document describing the objective, design, methods, statistical considerations, and organization of a trial, which provides the basis for conducting and monitoring the study.

Concealment of treatment assignment from participants, investigators, assessors, or analysts to reduce performance and detection bias in a clinical trial; also called masking.

The individual, company, institution, or organization that takes responsibility for initiating, managing, and financing a clinical trial and for ensuring compliance with applicable regulations.

The qualified person at a site who is responsible for conducting the trial according to the protocol and regulations and for the safety and welfare of enrolled participants.

A document listing site staff to whom the principal investigator has assigned specific trial tasks, with their qualifications and the duties delegated, supporting accountability and GCP compliance.

Oversight of a trial's progress to confirm it is conducted, recorded, and reported according to the protocol, standard operating procedures, GCP, and applicable regulations.

Records that individually and collectively allow evaluation of a trial's conduct and the quality of data produced, retained by the investigator and sponsor for inspection.

A departure from the approved trial plan; important ones may affect participant safety, data integrity, or scientific validity and usually require documentation and corrective action.

Original records and certified copies, such as medical charts, laboratory reports, and signed consent forms, where trial data are first recorded and later verified against case report forms.

A printed or electronic document designed to record protocol-required information for each participant and report it to the sponsor.

A formal request asking site staff to clarify, correct, or confirm data that appear missing, inconsistent, or outside expected ranges during data review.

A secure, computer-generated record documenting who created, changed, or deleted electronic data and when, preserving the history of changes for verification and inspection.

Data integrity principles requiring records to be attributable, legible, contemporaneous, original, and accurate, often extended to include complete, consistent, enduring, and available.

Use of computerized systems to enter trial data directly into a database, replacing paper case report forms and enabling edit checks, queries, and audit trails.

A standardized medical terminology used to code adverse events, medical history, and indications, enabling consistent aggregation and analysis of safety data across trials and databases.

Financial or personal interests that could compromise, or appear to compromise, professional judgment in conducting or reporting research, requiring disclosure and management.

The structured process of raising an unresolved issue to a higher level of authority, with defined triggers and timelines, so that risks are addressed promptly.

Identifying and involving parties affected by a trial, such as participants, advocacy groups, and clinicians, in planning and conduct to improve relevance and feasibility.

A communication pattern in which the sender gives a clear message, the receiver repeats it back, and the sender confirms accuracy, reducing errors in high-stakes handoffs.