ICH Flashcards
A systematic and independent examination of trial related activities and documents to determine whether the trial related activites were conducted and the data were recorded according to the protocol, sponsor’s SOP, and GCP
Audit
A compilation of the clinical and nonclinical data on the investigational product(s)
Investigator’s Brochure (IB)
A person or an organization contracted by teh sponsor to perform one of more of a sponsor’s trial related duties and functions
Contract Research Organization (CRO)
All noxious and unintended responses to a medicinal product related to any dose
Adverse Drug Reaction (ADR)
Documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced
Essential documents
Any untoward medical occurrence in a patient or subject which does not necessarily have a causal relationship with this treatment
Adverse Event (AE)
A person, who is independent of the trial, who cannot be unfairly influenced by peopled involved with the trial
Impartial witness
The act by regulatory authorities of conducting an official review of documents, facilities, records and any other resources that are deemed to be related to the clinical trial
Inspection
Audit
A systematic and independent examination of trial related activities and documents to determine whether the trial related activites were conducted and the data were recorded according to the protocol, sponsor’s SOP, and GCP
Investigator’s Brochure (IB)
A compilation of the clinical and nonclinical data on the investigational product(s)
Contract Research Organization (CRO)
A person or an organization contracted by teh sponsor to perform one of more of a sponsor’s trial related duties and functions
Adverse Drug Reaction (ADR)
All noxious and unintended responses to a medicinal product related to any dose
Essential documents
Documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced
Adverse Event (AE)
Any untoward medical occurrence in a patient or subject which does not necessarily have a causal relationship with this treatment
Impartial witness
A person, who is independent of the trial, who cannot be unfairly influenced by peopled involved with the trial
Inspection
The act by regulatory authorities of conducting an official review of documents, facilities, records and any other resources that are deemed to be related to the clinical trial
How quickly should SAEs be reported to the study sponsor upon awareness of the event
Immediately
Examples of what classifies as a SAE
- inpatient hospitalization or prolongation of existing hospitalization
- death
- life threatening
- significant disability/incapacity or congenital anomaly/birth defect
To what entity may the sponsor transfer trial-related duties or functions
Contract Research Organization (CRO)
If a sponsor transfer duties to a CRO, who holds responsibility for the quality and integrity of the trial data
Sponsor
Who holds responsibility for IP (investigational product) accountability
The investigator/institution
How frequently should IRB/IEC (**What is IEC??) conduct continuing review
at least once per year, at intervals appropriate to the degree of risk to human subjects
How long must the iRB retain records of the trial
at least 3 years
How long should the investigator retain essential documents of the trial
at least 2 years after the last approval of a marketing application in an ICH region
