Sponsor, IRB/IEC, Investigator Responsibilities

Question 1

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

Answer 1

Sponsor

Question 2

Who may transfer responsibility for any or all of the obligations for contract research organizations?

Answer 2

Sponsor

Question 3

True/False - The sponsor can partially transfer obligations to a contract research organization.

Answer 3

True, can transfer some obligations but must be written out to describe each obligation.

Question 4

True/False - The investigator shall ship investigational new drugs only to those participating in the clinical investigation.

Answer 4

False, the sponsor shall ship the investigational new drugs only to investigators participating in the investigation.

Question 5

Who shall select only investigators qualified by training and experience as appropriate experts to investigate the new drug?

Answer 5

Sponsor

Question 6

What shall the sponsor obtain from the investigator before they can begin the investigation of an IND?

Answer 6

1. A signed investigator statement (Form FDA-1572)
2. CV
3. Clinical Protocol
4. Financial disclosure information

Question 7

Who shall select a monitor qualified by training and experience as appropriate experts to monitor the progress of the study?

Answer 7

Sponsor

Question 8

When should the sponsor provide the Investigator’s Brochure to the investigators?

Answer 8

Before the investigation begins

Question 9

Can a sponsor also be the investigator of a clinical study?

Answer 9

Yes

Question 10

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.”

Answer 10

Sponsor; investigator; secure compliance; discontinue shipments; investigator; investigator

Question 11

Who reviews and evaluates the evidence relating to the safety and effectiveness of the drug as it is obtained from the investigator?

Answer 11

Sponsor

Question 12

How often should the sponsor make reports to the FDA regarding evidence of safety and effectiveness of the drug?

Answer 12

Annually

Question 13

Who shall maintain adequate records showing the receipt, shipment, or other disposition of the investigational drug?

Answer 13

Sponsor

Question 14

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.

Answer 14

False, the sponsor maintains these records.

Question 15

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.

Answer 15

2 years; 2 years

Question 16

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?

Answer 16

Sponsor

Question 17

Who should safeguard the rights, safety and well-being of all trial subjects?

Answer 17

IRB/IEC

Question 18

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?

Answer 18

IRB/IEC

Question 19

Who should conduct continuing review of each ongoing trial at intervals appropriate to the degree of risk to human subjects?

Answer 19

IRB/IEC

Question 20

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?

Answer 20

IRB/IEC

Question 21

Who should maintain a list of appropriately qualified persons to whom the investigator has delegated significant trial-related duties?

Answer 21

Investigator

Question 22

Who should demonstrate a potential for recruiting the required number of suitable subjects within the agreed recruitment period?

Answer 22

Investigator

Question 23

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?

Answer 23

Investigator

Question 24

Who is responsible for supervising any individual or party to who the investigator delegates trial-related duties and functions conducted at the trial site?

Answer 24

Investigator

Question 25

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?

Answer 25

Investigator

Question 26

Who should document and explain any deviation from the approved protocol?

Answer 26

Investigator

Question 27

Who is responsible for investigational product(s) accountability at the trial(s)?

Answer 27

Investigator

Question 28

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?

Answer 28

Investigator

Question 29

Who should follow the trial's randomization procedures, if any, and should ensure that the code is broken in accordance with the protocol?

Answer 29

Investigator

Question 30

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?

Answer 30

Investigator

Question 31

Who should maintain adequate and accurate source documents and trial records that include all pertinent observations on each of the site's trial subjects?

Answer 31

Investigator

Question 32

Who should submit written summaries of the trial status to the IRB/IEC annually, or more frequently, if requested by the IRB/IEC?

Answer 32

Investigator

Question 33

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?

Answer 33

Investigator

Question 34

Who focuses on trial activities essential to ensuring human subject protection and. the reliability of the trial results?

Answer 34

Sponsor

Question 35

Who should ensure that all aspects of the trial are operationally feasible and should avoid unnecessary complexity, procedures, and data collection?

Answer 35

Sponsor

Question 36

Who should identify risks to critical trial processes and data - considered at both the system level and clinical trial level?

Answer 36

Sponsor

Question 37

Who should decide which risks to reduce and/or which risks to accept?

Answer 37

Sponsor

Question 38

Who should document the quality management documents and communicate quality management activities to those who are involved in or affected by such acitivities?

Answer 38

Sponsor

Question 39

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?

Answer 39

Sponsor

Question 40

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?

Answer 40

Sponsor

Question 41

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?

Answer 41

Sponsor

Question 42

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)?

Answer 42

Sponsor

Question 43

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?

Answer 43

Sponsor

Question 44

Who may consider establishing an independent data monitoring committee to assess the progress of a clinical trial?

Answer 44

Sponsor

Question 45

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?

Answer 45

Sponsor

Question 46

Who should define, establish, and allocate all trial-related duties and functions?

Answer 46

Sponsor

Question 47

Who should provide insurance or indemnify the investigator against claims arising from the trial, except for claims that arise from malpractice and.or negligence?

Answer 47

Sponsor

Question 48

Who should submit any required application(s) to the appropriate authority(ies) for review, acceptance, and/or permission to begin the trial(s)?

Answer 48

Sponsor

Question 49

Who should update the Investigator's Brochure as significant new information becomes available?

Answer 49

Sponsor

Question 50

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?

Answer 50

Sponsor

Question 51

Who should determine for the investigational product(s) acceptable storage temperatures, storage conditions, storage times, reconstitution fluids and procedures, and devices for product infusion?

Answer 51

Sponsor

Question 52

Who is responsible for supplying the investigator(s) with the investigational product(s)?

Answer 52

Sponsor

Question 53

Who should maintain records that document shipment, receipt, disposition, return, and destruction. of the investigational product(s)?

Answer 53

Sponsor

Question 54

Who should ensure that the investigational product(s) are stable over the period of use?

Answer 54

Sponsor

Question 55

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?

Answer 55

Sponsor

Question 56

Who is responsible for the ongoing safety evaluation of the investigational products?

Answer 56

Sponsor

Question 57

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?

Answer 57

Sponsor

Question 58

Who should submit to the regulatory authority(ies) all safety updates and periodic reports, as required by applicable regulatory requirement(s)?

Answer 58

Sponsor

Question 59

Who should appoint a monitor?

Answer 59

Sponsor

Question 60

Who should determine the appropriate extent and nature of monitoring?

Answer 60

Sponsor

Question 61

Who should develop a monitoring plan that is tailored to the specific human subject protection and data integrity risks of the trial?

Answer 61

Sponsor

Question 62

Who should appoint individuals to conduct audits?

Answer 62

Sponsor

Question 63

Who should perform a root cause analysis and implement appropriate corrective and preventive actions?

Answer 63

Sponsor

Question 64

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?

Answer 64

Sponsor

Question 65

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?

Answer 65

Sponsor

Question 66

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)?

Answer 66

Sponsor