Sponsor, IRB/IEC, Investigator Responsibilities Flashcards
Responsible for:
- selecting qualified investigators, providing them with the information they need to conduct an investigation properly
- ensuring proper monitoring of the investigation(s)
- ensuring that the investigation(s) is conducted in accordance with the general investigational plan and protocols contained in the IND
- maintaining an effective IND with respect to the investigations
- ensuring that FDA and all participating investigators are promptly informed of significant new adverse effects or risks with respect to the drug
Sponsor
Who may transfer responsibility for any or all of the obligations for contract research organizations?
Sponsor
True/False - The sponsor can partially transfer obligations to a contract research organization.
True, can transfer some obligations but must be written out to describe each obligation.
True/False - The investigator shall ship investigational new drugs only to those participating in the clinical investigation.
False, the sponsor shall ship the investigational new drugs only to investigators participating in the investigation.
Who shall select only investigators qualified by training and experience as appropriate experts to investigate the new drug?
Sponsor
What shall the sponsor obtain from the investigator before they can begin the investigation of an IND?
- A signed investigator statement (Form FDA-1572)
- CV
- Clinical Protocol
- Financial disclosure information
Who shall select a monitor qualified by training and experience as appropriate experts to monitor the progress of the study?
Sponsor
When should the sponsor provide the Investigator’s Brochure to the investigators?
Before the investigation begins
Can a sponsor also be the investigator of a clinical study?
Yes
Fill in the blanks: “A ____ who discovers that an ________ is not complying with the signed agreement, the general investigational plan, or the requirements of this part of other applicable parts shall promptly either ________ or __________ of the investigational new drug to the __________ and end the ___________’s participation in the investigation.”
Sponsor; investigator; secure compliance; discontinue shipments; investigator; investigator
Who reviews and evaluates the evidence relating to the safety and effectiveness of the drug as it is obtained from the investigator?
Sponsor
How often should the sponsor make reports to the FDA regarding evidence of safety and effectiveness of the drug?
Annually
Who shall maintain adequate records showing the receipt, shipment, or other disposition of the investigational drug?
Sponsor
True/False: The investigator shall maintain complete and accurate records showing any financial interest paid to clinical investigators by the sponsor of the covered study.
False, the sponsor maintains these records.
Fill-in-the-blank. A sponsor shall retain the records and reports required by this part for ___________ after a marketing application is approved for the drug; or if an application is not approved for the drug, until _______ after shipment and delivery of the drug for investigational use is discontinued and FDA has been so notified.
2 years; 2 years
Who shall assure the return of all unused supplied of the investigational drug from each individual investigator whose participation in the investigation is discontinued or terminated?
Sponsor
Who should safeguard the rights, safety and well-being of all trial subjects?
IRB/IEC
Who should review a proposed clinical trial within a reasonable time and document its views in writing, clearly identifying the trial, the documents reviewed and the dates?
IRB/IEC
Who should conduct continuing review of each ongoing trial at intervals appropriate to the degree of risk to human subjects?
IRB/IEC
Who should review both the amount and method of payment to subjects to assure that neither presents problems of coercion or undue influence on the trial subjects?
IRB/IEC
Who should maintain a list of appropriately qualified persons to whom the investigator has delegated significant trial-related duties?
Investigator
Who should demonstrate a potential for recruiting the required number of suitable subjects within the agreed recruitment period?
Investigator
Who should ensure that all persons assisting with the trial are adequately informed about the protocol, the investigational product(s), and their trial-related duties and functions?
Investigator
Who is responsible for supervising any individual or party to who the investigator delegates trial-related duties and functions conducted at the trial site?
Investigator
Who should conduct the trial in compliance with the protocol agreed to by the sponsor and, if required, by the regulatory authority(ies) and which was given approval/favorable opinion by the IRB/IEC?
Investigator
Who should document and explain any deviation from the approved protocol?
Investigator
Who is responsible for investigational product(s) accountability at the trial(s)?
Investigator
Who should explain the correct use of the investigational product(s) to each subject and should check, at intervals appropriate for the trial, that each subject is following the instructions properly?
Investigator
Who should follow the trial’s randomization procedures, if any, and should ensure that the code is broken in accordance with the protocol?
Investigator
Who should provide the subject or the subject’s legally acceptance representative ample time and opportunity to inquire details of the trial and to decide whether or not to participate in the trial?
Investigator
Who should maintain adequate and accurate source documents and trial records that include all pertinent observations on each of the site’s trial subjects?
Investigator
Who should submit written summaries of the trial status to the IRB/IEC annually, or more frequently, if requested by the IRB/IEC?
Investigator
Who should promptly inform the trial subjects, assure appropriate therapy and follow-up for the subjects, and regulatory authority(ies) that the trial is prematurely terminated or suspended for any reason?
Investigator
Who focuses on trial activities essential to ensuring human subject protection and. the reliability of the trial results?
Sponsor
Who should ensure that all aspects of the trial are operationally feasible and should avoid unnecessary complexity, procedures, and data collection?
Sponsor
Who should identify risks to critical trial processes and data - considered at both the system level and clinical trial level?
Sponsor
Who should decide which risks to reduce and/or which risks to accept?
Sponsor
Who should document the quality management documents and communicate quality management activities to those who are involved in or affected by such acitivities?
Sponsor
Who should periodically review risk control measures to ascertain whether the implemented quality management activities remain effective and relevant, taking into account emerging knowledge and experience?
Sponsor
Who should describe the quality management approach implemented in the trial and summarize important deviations from the predefined quality tolerance limits and remedial actions taken in the clinical study report?
Sponsor
Who is responsible for implementing and maintaining quality assurance and quality control systems with written SOPs to ensure that trials are conducted and data are generated, documented (recorded), and reported in compliance with the protocol, GCP, and the applicable regulatory requirements?
Sponsor
Who’s is responsible for securing agreement from all involved parties to ensure direct access to all trial related sites, source data/documents, and reports for the purpose of monitoring and auditing by the sponsor, and inspection by domestic and foreign regulatory authority(ies)?
Sponsor
Who may transfer any or all of the sponsor’s trial-related duties and functions to a CRO, but the ultimate responsibility for the quality and integrity of the trial data always reside with this person?
Sponsor
Who may consider establishing an independent data monitoring committee to assess the progress of a clinical trial?
Sponsor
Who should inform the investigator(s) in writing the need for record retention and notify the investigator(s) in writing when the trial related records are no longer needed?
Sponsor
Who should define, establish, and allocate all trial-related duties and functions?
Sponsor
Who should provide insurance or indemnify the investigator against claims arising from the trial, except for claims that arise from malpractice and.or negligence?
Sponsor
Who should submit any required application(s) to the appropriate authority(ies) for review, acceptance, and/or permission to begin the trial(s)?
Sponsor
Who should update the Investigator’s Brochure as significant new information becomes available?
Sponsor
Who should ensure that the investigational product(s) is characterized as appropriate to the stage of development of the product(s), is manufactured in accordance with any applicable GMP, and is coded and labelled in a manner that protects the blinding?
Sponsor
Who should determine for the investigational product(s) acceptable storage temperatures, storage conditions, storage times, reconstitution fluids and procedures, and devices for product infusion?
Sponsor
Who is responsible for supplying the investigator(s) with the investigational product(s)?
Sponsor
Who should maintain records that document shipment, receipt, disposition, return, and destruction. of the investigational product(s)?
Sponsor
Who should ensure that the investigational product(s) are stable over the period of use?
Sponsor
Who should verify that each subject has consented, in writing, to direct access to his/her original medical records for trial-related monitoring, audit, IRB/IEC review, and regulatory inspection?
Sponsor
Who is responsible for the ongoing safety evaluation of the investigational products?
Sponsor
Who should expedite the reporting to all concerned investigator(s), to the IRBs/IECs, where required, and to the regulatory authority(ies) of all adverse drug reactions (ADRs) that are both serious and unexpected?
Sponsor
Who should submit to the regulatory authority(ies) all safety updates and periodic reports, as required by applicable regulatory requirement(s)?
Sponsor
Who should appoint a monitor?
Sponsor
Who should determine the appropriate extent and nature of monitoring?
Sponsor
Who should develop a monitoring plan that is tailored to the specific human subject protection and data integrity risks of the trial?
Sponsor
Who should appoint individuals to conduct audits?
Sponsor
Who should perform a root cause analysis and implement appropriate corrective and preventive actions?
Sponsor
Who should terminate the investigator’s participation in the trial if the monitoring and/or auditing identifies serious and/or persistent noncompliance on the part of an investigator?
Sponsor
Who should promptly inform the investigator(s), and the regulatory authority(ies) of the termination or suspension and the reason(s) for the termination or suspension?
Sponsor
Who should ensure that the clinical trial reports are prepared and provided to the regulatory agency(ies) as required by the applicable regulatory requirement(s)?
Sponsor
