Show:
Acronyms
Definitions
Potpourri
Clinical Trial Phases
Visit Types
100
CRO
What is Clinical Research Organization?
100
A scientifically controlled study of the safety and effectiveness of a therapeutic agent (as a drug or vaccine) using consenting human subjects
What is Clinical Trial?
100
The plan helps to create a standard for preparation, review and approval of all Investigator Packages. This plan contains a description of documents and process flow required for approval of initial drug shipment to sites.
What is Investigator Package Plan (IPP)?
100
The first time the drug is given to humans (healthy volunteers and oncology patients).
What is Phase I?
100
During this visit, the CRA will review with the study staff the investigator responsibilities, Protocol and CRFs, SAE and AE reporting, Access to source documents, Laboratory arrangements, Study medication management, answer any questions the site may have regarding the study and / or study requirements, and Records retention during and after the study.
What is Site Initiation Visit (SIV)?
200
ICF
What is Informed Consent Form?
200
A list of commitments and requirements by the FDA for each investigator performing drug/biologics studies; also referred to as a statement of the investigator.
What is FDA Form 1572?
200
The purpose of this document is to be a mechanism to capture protocol violation and data alerts; documentation of review; communication tool between the monitor and the site; identify error/inconsistencies between CRF and source documents.
What is Monitoring Notes?
200
In this study phase, additional data is collected regarding the safety and efficacy of a study drug or device.
What is Phase IV?
200
During this visit, the CRA will meet with the PI and study staff; give an overview of the protocol; review critical issues – Inclusion/Exclusion, Efficacy, Safety; tour the facility; review the site’s IRB / ethics committee approval process and timelines; assess the staff’s knowledge of GCP; assess the level of staffing; and answer any questions and address any foreseeable problems.
What is Pre-Study Visit (PSV)?
300
EDC
What is Electronic Data Capture?
300
Responsible for the design, planning, implementation, and overall direction of clinical research projects. Evaluates and analyzes clinical data and coordinates activities to ensure compliance with protocol and overall clinical objectives. May also travel to field sites to supervise and coordinate clinical studies.
What is Clinical Research Associate or Monitor?
300
This plan outlines visit schedules and duration, activities required at each visit, gives workable guidelines and action plans for the visits, provides guidance on issue escalation, and helps to provide consistency across all projects and regions.
What is Monitoring Plan?
300
This is the confirmation phase of drug development; large numbers of subjects and clinical sites are included; Long term outcome studies – may be up to 5 years or longer for treatment; All of these studies require .
What is Phase III
300
During this visit, the CRA will ensure that subjects have signed the ICF, ensure the eligibility of subjects, complete source document verification, ensure that protocol requirements are being met, answer any questions the site may have regarding the study or study requirements, and perform drug accountability.
What is Routine Monitoring Visit?
400
SAE
What is Serious Adverse Event?
400
Any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity or is a congenital anomaly/birth defect.
What is Serious Adverse Event?
400
DAILY DOUBLE
What is ?
400
This phase can include the following types of studies: Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and Food effect.
What is Phase I?
400
During this visit, the CRA will ensure all CRFs are corrected and collected; verify all data queries are completed; discuss record retention; drug accountability is complete; IRB / IEC has been notified and documents are filed; and all regulatory documents are filed and complete.
What is Close Out Visit (COV)?
500
ADR
What is Adverse Drug Reaction?
500
A federal regulation that safeguards health care recipients' personal health information. The policy provides protection for individuals, while allowing entities to share information for the sake of quality care. Governed by the Office of Civil Rights and the U.S. Department of Health and Human Services.
What is HIPAA (Health Insurance Portability and Accountability Act)?
500
Name 3 parts of the Informed Consent Process.
What is Subject is told: o The Purpose of the clinical trial o The risks, side effects or discomforts that may be reasonably expected o Any benefits that may be reasonably expected o What will happen in the study and whether any procedures, drugs or devices are different than those that are used in standard medical treatment o All options available to the subject and how they are better or worse than being in a clinical trial o Any medical treatments available if complications occur during the trial Subjects are allowed to ask any questions about the trial prior to consenting and /or at any time during the course of the trial Subjects are allowed ample time, without pressure, to decide whether or not to consent to participate Subjects may refuse to participate, for any reason, before and after the trial has started Subjects will receive a signed and dated copy of the informed consent form
500
This phase of study includes subjects who are patients with the disease; small number of subjects and sites are included; studies may have more than one treatment dose arm and is usually placebo controlled; and treatment is usually monotherapy.
What is Phase II?
500
During this visit, the CRA will ensure that all essential regulatory documents are available on-site and in the regulatory binder(s).
What is SIV, RMV and COV?