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SOCRA CCRP CERTIFICATION > Sponsor, IRB/IEC, Investigator Responsibilities > Flashcards

Sponsor, IRB/IEC, Investigator Responsibilities Flashcards

1
Q

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

A

Sponsor

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2
Q

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

A

Sponsor

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3
Q

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

A

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

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4
Q

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

A

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

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5
Q

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

A

Sponsor

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6
Q

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

A
  1. A signed investigator statement (Form FDA-1572)
  2. CV
  3. Clinical Protocol
  4. Financial disclosure information
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7
Q

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

A

Sponsor

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8
Q

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

A

Before the investigation begins

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9
Q

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

A

Yes

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10
Q

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.”

A

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

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11
Q

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

A

Sponsor

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12
Q

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

A

Annually

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13
Q

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

A

Sponsor

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14
Q

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.

A

False, the sponsor maintains these records.

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15
Q

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.

A

2 years; 2 years

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16
Q

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?

A

Sponsor

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17
Q

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

A

IRB/IEC

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18
Q

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?

A

IRB/IEC

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19
Q

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

A

IRB/IEC

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20
Q

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?

A

IRB/IEC

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21
Q

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

A

Investigator

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22
Q

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

A

Investigator

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23
Q

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?

A

Investigator

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24
Q

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

A

Investigator

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25
Q

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?

A

Investigator

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26
Q

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

A

Investigator

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27
Q

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

A

Investigator

28
Q

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?

A

Investigator

29
Q

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

A

Investigator

30
Q

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?

A

Investigator

31
Q

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

A

Investigator

32
Q

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

A

Investigator

33
Q

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?

A

Investigator

34
Q

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

A

Sponsor

35
Q

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

A

Sponsor

36
Q

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

A

Sponsor

37
Q

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

A

Sponsor

38
Q

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

A

Sponsor

39
Q

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?

A

Sponsor

40
Q

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?

A

Sponsor

41
Q

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?

A

Sponsor

42
Q

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)?

A

Sponsor

43
Q

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?

A

Sponsor

44
Q

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

A

Sponsor

45
Q

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?

A

Sponsor

46
Q

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

A

Sponsor

47
Q

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

A

Sponsor

48
Q

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

A

Sponsor

49
Q

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

A

Sponsor

50
Q

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?

A

Sponsor

51
Q

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

A

Sponsor

52
Q

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

A

Sponsor

53
Q

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

A

Sponsor

54
Q

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

A

Sponsor

55
Q

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?

A

Sponsor

56
Q

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

A

Sponsor

57
Q

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?

A

Sponsor

58
Q

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

A

Sponsor

59
Q

Who should appoint a monitor?

A

Sponsor

60
Q

Who should determine the appropriate extent and nature of monitoring?

A

Sponsor

61
Q

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

A

Sponsor

62
Q

Who should appoint individuals to conduct audits?

A

Sponsor

63
Q

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

A

Sponsor

64
Q

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?

A

Sponsor

65
Q

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?

A

Sponsor

66
Q

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)?

A

Sponsor

67
Q
A

SOCRA CCRP CERTIFICATION (9 decks)

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