Exam Question Flashcards
What does ICH stand for, which countries formed it, why?
International Council for Harmonisation-European Union, Japan, U.S.-standardized guidelines for clinical research of investigational drugs. Established standards for quality, safety, and efficacy and reduction of redundant testing.
What is GCP?
Good Clinical Practice-standard for designing, conducting, monitoring, and reporting clinical research. Ensures human subjects are protected and data submitted to market IND is accurate and credible.
What is the ICH E6?
“Efficacy” defines GCP in a manner consistent with the Declaration of Helsinki. To assure that the rights, well-being, and confidentiality of trial subjects are protected and to assure that trial data are credible.
Principles of ICH GCP
- Clinical trials should be conducted in accordance with ethical principles that have their origin in DOH consistent with GCP reg requirements.
- Benefits should outweigh the risks
*The rights, safety and well-being of trial subjects is number one priority
*All information on an IND should support the clinical trial
*Clinical trials should be described clearly in a protocol - The protocol has received prior IRB/IEC/REB approval
*Medical care and decisions should be the responsibility of a qualified physician
*Each individual involved in the trial should be qualified by education, training and experience - Informed consent should be freely given by the trial subject prior to participation
*All Trial info should be recorded, handled and stored to allow accurate reporting, interpretation and verification.
*Subjects confidentiality should be protected
*IND products should be manufactured, handled and stored in accordance with GMP (Good Manufacturing Practice)
What is the purpose of informed consent?
-protect research subjects
-ensure the subject understands the benefits and risks
-provide all information needed to make a decision
What are the guiding principles for informed consent?
-Nuremburg Code
-Declaration of Helsinki
-Belmont Report
-Country-specific policies and guidelines (U.S. FDA regulations 21 CFR 50.25 and U.S. Department of Health and Human Services at 45 CFR 46)
-ICH E6(R2)
What are the components of the Informed Consent Process?
-The form with ICH E6 Section 4.8.10 components, IRB approval, correct version
-The Dialogue
-Adequate Time
-Understanding
-Signatures
-Re-consenting
What would require re-consent?
-Increased risk
-New risks
-New previously unknown serious side effect
-Decrease in benefit
-New Standard of care alternatives
-Changes to medical treatment choices
-Change in drug dosage/device application
-Change in exposure to the drug/device
-Change in duration of participation in the trial
-Significant increase in number of research subjects
-Change in use of samples taken
ICH topics and guidelines fall into four main categories
Quality, Safety, Efficacy, Multidisciplinary
The ICH E6 guidelines should be followed when
Generating clinical trial data that are intended to be submitted to regulatory authorities
Investigator’s role:
overall conduct of the study at the site which includes protecting the rights and welfare of the participants, ensuring validity and integrity of the data collected
Sponsor’s role:
initiation, management and/or financing of the trial
Qualified Investigator
Needs education, experience and training. Must be aware of GCP and reg requirements. Must be familiar with the protocol, IB, and use of IND as applicable.
What resources must investigators demonstrate they have to conduct studies?
suitable subjects, time, adequate facilities and qualified study members
