FREE Introduction to Certified Clinical Research Associate Questions and Answers
Dosage and safety (Find out how the medicine affects human metabolism and pharmacology).
The primary purpose of a Phase 1 study in clinical research is to evaluate the safety and dosage of a drug in humans. Phase 1 studies are typically the first stage of clinical trials and involve a small number of healthy volunteers or individuals with the target disease or condition.
When an investigator is taking part in a fresh protocol that has been added to the IND
When a fresh researcher is brought into the research
The Form FDA 1572 collects information about the investigator, the site, and the qualifications of the investigator to conduct the study. It also includes a statement of commitment to follow the protocol, comply with Good Clinical Practice (GCP) guidelines, and report any adverse events or safety concerns.
The initial recording of data for a clinical study is called __________ and comprises notes from observations, lab results, and other relevant documents.
Source documents are the original records or materials that provide evidence or information about a subject's participation in a clinical study. These documents serve as the primary sources of data and play a crucial role in ensuring the accuracy, reliability, and integrity of the study data.
Any type of legal body, such as a business, a nonprofit group, or an individual, may serve as _______
In the context of clinical trials, the term "sponsor" refers to the entity or organization that takes responsibility for the initiation, management, and funding of a clinical study. The sponsor can be any legal entity, including a pharmaceutical or biotechnology company, a contract research organization (CRO), an academic institution, a government agency, or even an individual researcher.
The IRB is not required under the FDA standards to make sure that children's consent is secured.
According to the International Council for Harmonisation (ICH) guideline E6, section 1.33, the definition of an investigational drug is as follows: "A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use."
Analysis of all trial participants who followed procedure and finished the experiment
Per protocol analysis is a statistical approach that includes only those participants who completed the study according to the predefined protocol without major protocol deviations or non-compliance. It aims to assess treatment efficacy among a subgroup of participants who adhered closely to the study procedures.
Statistical evaluation of subject data according to the group they were placed in despite not adhering to the study protocol
In an intention-to-treat analysis, participants are analyzed based on the group to which they were originally assigned, regardless of whether they received the intended treatment or fully complied with the study protocol. This approach aims to maintain the principle of randomization and preserve the benefits of random assignment, such as controlling for confounding factors and reducing bias.