Good Clinical Practice (GCP)
These are the two main purposes of GCP
What are to ensure subject rights and trial data integrity?
This person is responsible for the conduct of the clinical trial at a trial site
Who is the Investigator?
This exists when an individual's financial, personal, or professional relationships create the potential for bias or interfere with their objectivity in conducting or reporting clinical research.
What is a Conflict of Interest (COI)?
The initials IRB stand for this
What is the Institutional Review Board?
This document ensures participants are aware of potential risks and benefits of a study
What is a Informed Consent Form?
Patient Data Confidentiality is primarily governed by this
What is HIPAA?
What is 30?
This is the term for comparing CRF/EDC entries to original source documents to confirm accuracy.
What is source data verification (SDV)?
If a PI insists on including a participant who fails inclusion criterion, you should document the discussion, and advise the PI it would be filed as this
What is a protocol deviation?
This is the term for an individual or juridical body authorized under applicable law to consent, on behalf of a prospective subject, to the subject's participation in the clinical trial
What is a LAR (Legally Acceptable Representative)?
This document from 1964 forms the basis of ethical considerations in clinical research
What is the Declaration of Helsinki?
If an unanticipated problem involving risk to subjects occurs, it must be reported promptly to these two bodies
Who are the IRB and the sponsor?
This is a systematic and independent examination of trial-related activities and documents to determine whether the evaluated trial-related activities were conducted and the data were recorded, analyzed, and accurately reported according to the protocol, sponsor's SOPs, GCP, and the applicable regulatory requirements
What is an Audit?
This form is to be used to document the commitment of the investigator to conduct the clinical trial in compliance with the FDA regulations and to provide assurance that the investigator is qualified to conduct the study.
What is a 1572 "Statement of Investigator" form?
What does ICH GCP state about the investigator or trial staff persuading subjects to take part in a trial? "Neither the investigator nor the trial staff should ____________ a subject to participate or to continue to participate in a trial."
Coerce of Unduly Influence
Prior to a subject's participation in the trial, this document should be signed and personally dated by the subject or by the subject's legally authorized representative (LAR)
What is Written Informed Consent?
Serious Adverse Events (SAEs) should be reported to the sponsor in this timeframe of site awareness, per protocol and sponsor SOPs
What is Immediately (Within 24 hours)?
According to 21 CFR Part 56, the IRB must at least review continuing studies at this frequency
What is annually?
Enrollment and dosing of a subject who does not meet inclusion criteria is an example of this
What is a major protocol deviation?
When new information arises that may affect a subject's willingness to continue, such as a new risk or change within the study, the study staff is required to conduct this
When is re-consent?
According to the principles of ICH GCP, this is the most important consideration when conducting a clinical trial
What is Protect Trial Subjects?
This is considered a Serious Adverse Event (SAE)
What are Hospitalization, Death, or persistent disability?
Two examples of an indirect identifiers are this
What are Subject Initials and Date of Birth?
An action plan to take corrective steps, address nonconformities, find root causes, and prevent reoccurrence is commonly referred to as this
What is a CAPA plan?
A source document correction should be maintained by doing what?
Be crossed out with a single line, initialed, dated, and explained.