ICH-GCP Flashcards
An audit is defined as
A systematic and independent examination of clinical trial related activities and documents
And inspection is defined as
Official review of documents, facilities, records and any other resources
Monitoring is defined as
Overseeing the progress of a clinical trial
Clinical trial is defined as
And investigation intended to discover and verify the clinical effects of an investigational product
An investigator is defined as
A person responsible for the conduct of the clinical trial
A sponsor is defined as
A person or entity responsible for initiation, management and financing of a clinical trial.
A monitor is defined as
A person responsible for overseeing the progress of a clinical trial
A sub investigator is defined as
And individuals supervised by the team leader
A coinvestigator is defined as
A person responsible for assuming, when needed, the responsibilities of an investigator or a team leader.
Quality assurance is defined as
Planned and systematic action to ensure that the data is generated, recorded and reported according to GCP
ICH-GCP Requires that a regulatory authority be given direct access to your clinical trial records. Direct access includes the ability to do
Examine and analyze all clinical trial records, verify the clinical trial records, reproduce any records as needed.
Source documents in a clinical trial referred to
Medical notes and pertinent parts of the medical record, laboratory and radiology findings, pathology reports, patient diaries and pharmacy records. NOT site monitoring reports!
Audits are generally performed by a regulatory authority where is monitoring is done by a CRO or sponsor, true or false?
True
The ethical framework cited in ICH-GCP As a framework for conducting clinical trials is
Declaration of Helsinki
The role specifically of medical physician as responsible for medical decisions is affirmed in
ICH and DHHS
Regarding informed consent in clinical trials ICH states that
Informed consent should be obtained from every subject
Regarding the protection of privacy and confidentiality, I CH
Affirms that privacy and confidentiality be protected in accordance with applicable regulatory requirements
Regarding the storage and handling of investigational products ICH
Affirms that handling and storage should be in accordance with GMP
With regard to quality assurance in clinical trials ICH affirms all of the following
States that systems with procedures that assure quality be implemented for every aspect of the clinical trial, the sponsor is responsible for implementing and maintain quality assurance and quality control with written SOP’s, quality control will be applied to every stage of data handling.
Agreements between the sponsor and the investigator should be
In writing as part of the protocol or in a separate agreement
Regarding final report on completion of the clinical trial investigator should according to ICH do all of the following
Provide the IRB with a summary of the trials outcome, provide a report to regulatory authorities, should inform the institution.
According to ICH the IRB should obtain the following documents from the investigator
Protocol, consent, recruitment procedures, investigators brochure, payments.
According to ICH the copy of the CV given to the IRB should be
Current
The statement that continuing review be carried out by at least once annually is affirmed by
DHHS, ICH, and FDA
the requirements in ICH differ from DHHS requirements in
Requirements for review of non-therapeutic trials
Regarding ICH provisions for emergency use of an investigational article which of the following is applicable?
ICH states that if consent of subject or LAR cannot be obtained then relevant at the goal concerns and applicable regulatory requirements be addressed
With regard to payments to subjects ICH indicates that
Payments be free of coercion and undue influence, payment should be prorated, method amounts and schedule the payments be set forth in the informed consent.
With regard to a quorum for the IRB ICH specifies that
It should be stipulated in the written procedures
According to ICH the investigator should promptly report the following to the IRB
Deviations from protocol to eliminate immediate hazards, changes in risk to protocol, serious and unexpected adverse drug reactions, new information that may affect the safety of subjects.
According to ICH, the sponsor may request the following from the IRB
Written procedures and membership lists
According to ICH the investigator should
Demonstrate the potential for a recruiting the required number of subjects, have sufficient time and staff to conduct a trial, ensure that the delegated staff to be informed about the protocol, duties and the product
According to ICH the investigator should
Ascertain the reason for withdrawal of a subject, and from the subject position about subject participation and a clinical trial, and ensure the adequate care is provided for any adverse event experience by the subject
With regard to keeping the IRB informed about the investigators brochure ICH states that
It is the investigators responsibility
If the investigator implement the change in the protocol to eliminate an immediate hazard the following entities should be informed
The IRB, the sponsor, regulatory authority if applicable
Responsibility for the investigational product and its accountability be assigned to
The pharmacist
Accountability for the investigational product includes
Delivery and inventory at the trial site, use and return of the product, badge, serial numbers and expiration dates
With regard to randomization the investigator should
Follow the sponsors randomization plan, and explain to the sponsor any premature unblinding due to an adverse event
According to ICH the informed consent should be
Signed and dated by subject and the person obtaining consent
The following agreements between sponsor and investigator should be documented in writing
Financial agreements and contracts, protocol agreement document, investigators brochure we speak and confidentiality documents
According to ICH the case report form should be
Consistent with source documents, dated initialed and explained when needed, show the original when corrections are made
Serious adverse events in a clinical trial should be reported to the sponsor according to ICH
Immediately
When the IRB suspend the clinical trial it should inform
The institution, the sponsor, OHRP
According to ICH the ultimate responsibility for the quality and integrity of the data rests with
The sponsor
Under ICH sponsors responsibilities for electronic data handling include all the following
Accuracy, reliability and consistent performance guided by SOP’s, security and back up of this song and access to authorize individuals only, safeguarding of the blinding
If the sponsor discontinues his clinical development of drug the records of the clinical trials should be retained for
Two years
An ICH, with regard to the retention of records by the investigator, the sponsor
Can request retention for as long as the sponsor needs the data, can request retention for at least two years post IND approval according to FDA guidelines, and should notify the investigator in writing when the records are no longer needed
According to ICH the purpose of monitoring is
Protect the rights and well-being of the human subjects, ensure data are accurate complete verifiable, the conduct of the trial is in agreement with a protocol, the clinical practice, and regulatory requirements
With regard to the training of monitors ICH states that they should be
Appropriately trained with document of qualifications, have they needed specific scientific and clinical knowledge, and be familiar with the protocol and the consent form
In determining the extent of monitoring the sponsors should consider
Objective, design, complexity, blinding & size
The monitor should
Serve as the main line of communication between the sponsor and the investigator
With regard to the investigator the monitor should
Verify that the investigator has adequate qualifications, resources, facilities and staff
With regard to drug accountability the monitor should
Verify storage items and adequacy of supplies, verify whether eligible patients are getting the drug at the right doses, verify whether subjects are informed and trained about drug use in storage, and verify the receipt, use, return and disposition of unused drugs
The study monitor verifies
final disposition of unused drug during
Study closeout visit
The study monitor reviews case report forms during
Routine site visits
The study monitor reviewed the protocol and schedule of assessments with the staff during
Site initiation visit
The study monitor assess of the investigators qualification, resources in facilities during
Pre-study visit
The study monitor should verify all the following
Informed consent, receipt and distribution of current copies of the investigators brochure, delegation of duties to staff, eligibility of enrolled subjects, recruitment rate, case report forms and source documents, and record of field visit intestine procedure is not done
The site monitors findings should be summarized in
Periodic site monitoring reports
According to ICH for noncompliance which is serious or persistent is observe the sponsor should
Terminate the investigators participation in the clinical trial, inform the IRB, and inform regulatory authorities
According to ICH and multi center trials the sponsor should
Carefully to find the responsibilities of the coordinating site principal investigator
Regarding protocol and GCP deviations observed by the monitor in a periodic site visit the sponsor me
Require that these be recorded promptly to the IRB, institute a corrected measure promptly, and or develop a CAPA plan as needed
Regarding withdraws or dropouts among study subjects, ICH recommends that
They be recorded and explained on the appropriate CRFs
ICH guidelines for trial design and protocol preparation include
Description of the designs, randomization and blinding, dosage regimens, stopping rules, and data recorded directly without source documents
ICH guidelines for protocol preparation and clinical trials include
Inclusion and exclusion criteria, withdraw and replacement of subjects, schedule of assessments, assessments of safety and efficacy, statistical analysis, and publication policy
Description of the investigators brochure is included in
ICH
According to ICH the investigators brochure should include
Physical, chemical and pharmaceutical properties and formulations, non-clinical studies and putting on clinical pharmacology, pharmacokinetics and toxicology, affects in Hammond, and a summary of data and guidance for the investigator
You must to get a brochure is a living document that is continually updated in a clinical trial to include
The latest non-clinical studies
According to ICH the essential documents to be placed on file before the start of a clinical trial include
Investigators brochure, protocol and other sponsor agreements, informed consent, recruiting and advertising information, financial aspects and insurance information, IRB approval’s, CV for investigator and co-investigator, randomization and any coding information, and site initiation report and pre-clinical site sustainability assignments
According to our CHD additional documents to be placed on file during a clinical trial include
Enrollment and screening logs, annual reports to the IRB, signature sheet, DOA, drug accountability records
According to ICH; additional documents to be included on file after completion of the trial are
Final closeout study monitoring report, final record the IRB, and clinical study report to document results and interpretation of trial
According to ICH the following statements about the involvement of a CRO in a clinical trial are correct
A sponsor may transfer any or all of the trial related duties and functions to a CRO, the CRO should implement quality assurance and quality control, and the delegated CRO responsibility should be specified in writing
The medical safety officer at the sponsor carries out which duties
Providing medical advice during the clinical trial, assessing medical waivers of eligibility, and review of essay ease and continuance of subjects, study
If the investigator terminates the trial at the site without prior approval from the sponsor he should inform the following in writing of his decision
IRB, institution, sponsor
Regarding the issuance of a final report by the investigator that ICH advises that the investigator should
Inform the institution, provide the IRB with a summary of the trials outcome, and provide regulatory authorities with any reports that may be required
According to ICH, for an investigator to be eligible to conduct a clinical trial he should be
Qualified by education training and experience, meet the qualifications specified by regulatory authorities in the IRB, and should provide documentary evidence of his qualifications to the sponsor and the IRB
ICH advises the following individuals may be utilized in trial design
Biostatisticians, clinical pharmacology, physicians
ICH advises that the terms of compensation for claims arising during a clinical trial the sponsor should
Provide insurance or indemnify the investigator
Regarding the monitors reports ICH advises that they include
Maybe in written form, dated and signed, include a summary of what was reviewed, deviations and deficiencies in actions to be taken, and review and follow up of report with the sponsor
Regarding the sponsors audits of a clinical trial ICH advises all of the following
Written procedures to be followed in the event of an audit the audit plan take into account the complexity and importance of the clinical trial, where applicable an audit certificate should be issued
