KT2 Flashcards
what is Enrolment of subjects ?
The clinical investigator has primary responsibility for recruiting subjects,
ensuring that only eligible subjects are enrolled in the study, and obtaining and
documenting the informed consent of each subject
- Informed consent form
Within GCP, informed consent must be obtained from each study subject prior
to enrolment in the study or performing any specific study procedures.
what is The investigational
product(s) ?
Quality of the investigational product is assured by compliance with Good
Manufacturing Practice (GMP) and by handling and storing the product
according to the manufacturing specifications and the study protocol.
what is Trial data acquisition: conducting the trial?
Research should be conducted according to the approved protocol and
applicable regulatory requirements.
– Study records documenting each trial-related activity provide critical
verification that the study has been carried out in compliance with the protocol
what is Safety management and reporting?
All clinical trials must be managed for safety.
–the clinical investigator has primary responsibility for alerting the sponsor and the IEC/IRB to adverse
events, particularly serious/life-threatening unanticipated events, observed
during the course of the research.
The sponsor, in turn, has primary responsibility for reporting of study safety to regulatory authorities and other investigators and for the ongoing global safety
assessment of the investigational product.
– A data and safety monitoring board (DSMB) may be constituted by the sponsor
to assist in overall safety management.
what is Monitoring the trial?
Sponsors generally perform site monitoring of a clinical trial to assure high quality trial conduct
what is Managing trial data?
Managing clinical trial data appropriately assures that the data are complete, reliable and processed correctly, and that data integrity is preserved.
– Data management includes all processes and procedures for collecting, handling, manipulating, analysing, and storing/archiving of data from study start to completion.
– The sponsor bears primary responsibility for developing appropriate data
management systems.
– The sponsor and the investigator share responsibility for implementing such
systems to ensure that the integrity of trial data is preserved.
what is Quality assurance of the trial performance and data?
Quality assurance (QA) verifies through systematic, independent audits that existing quality control systems are working and effective.
– Quality assurance audits may be performed during the course of the clinical trial and/or upon trial completion.
– Sponsors bear primary responsibility for establishing quality systems and conducting quality assurance audits.
what is Reporting the trial?
The results of each controlled study involving an investigational product should be summarized and described in an integrated clinical study report containing clinical data and statistical descriptions, presentations, and analyses.
– The report should be complete, timely, well-organized, free from ambiguity, and easy to review.
– The sponsor is responsible for preparing clinical study reports
