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SOCRA CCRP 2020 > Investigator roles and responsibilities > Flashcards

Investigator roles and responsibilities Flashcards

1
Q

What are the required qualifications of the clinical investigator?

A
  • Investigator should be qualified by education, training, and experience according to regulations
  • Investigator should be familiar with the intervention
  • Investigator should allow sponsor to monitor and audit
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2
Q

All trial-related medical or dental decisions should be made by whom?

A

A qualified physician or dentist who is an investigator or subinvestigator for the trial.

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3
Q

True or False: The Investigator and the Sponsor are required to sign the protocol to confirm the agreement.

A

True.

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4
Q

Who is responsible for documenting and explaining any deviation from the approved protocol.

A

The investigator or person designated by the investigator.

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5
Q

What is required for an investigator to implement a deviation from the protocol?

A
  • Approval of the change from the sponsor and IRB/IEC.
  • If immediate hazard to trial subjects is possible or the change is logistical/administrative, approval is not required.
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6
Q

An investigator implements a deviation from the protocol to eliminate an immediate hazard to a trial subject without prior IRB/IEC approval. What must happen next?

A

-ASAP the change, reasons for the change and, if relevant, proposed protocol changes should be submitted to the:
A) IRB/IEC for review and opinion
B) Sponsor for agreement
C) Regulatory authorities (only if required)

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7
Q

True or False: The sponsor is responsible for investigational product(s) accountability at the trial site(s)

A

False. The investigator/institution is responsible.

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8
Q

Investigational product(s) should be stored as specified by the __________.

A

Sponsor.

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9
Q

What records should be maintained by the investigator or designated pharmacist in regards to use of the investigational product?

A

1) Delivery of the product to the trial site
2) Product inventory at the site
3) Use of what product by each subject
4) Return or disposition of unused product at the end of trial
5) ID’s, dates, quantities, batch/serial numbers, etc.

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10
Q

If the trial is blinded, the _______ should promptly document and explain to the ________ any premature unblinding of the investigational product(s).

A

Investigator, Sponsor.

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11
Q

When should an investigator revise a written informed consent form?

A

Whenever important new information becomes available that may be relevant to the subject’s consent. This should be approved by the IRB/IEC ahead of use.

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12
Q

True or False. The language in the informed consent should be highly technical.

A

False. The language should be as non-technical as practical and should be understandable to the subject, the subjects LAR and any impartial witness.

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13
Q

True or False. The investigator is required to explain correct use for the investigational product to each subject and should check at intervals during the trial to ensure the subjects are following instructions properly.

A

True.

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14
Q

The written informed consent form should be signed AND personally dated by the ______ (or ________ if applicable) and the ________.

A

Subject (or LAR if applicable) and the person who conducted the informed consent discussion.

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15
Q

What happens during the informed consent process if a subject or LAR is unable to read?

A

An impartial witness needs to be present during the entire informed consent discussion. When the subject/LAR are orally consented, they sign and personally date the consent form and the witness signs and personally dates the consent form to attest that the information was accurately explained.

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16
Q

According to ICH GCP, how many of the following are included in the informed consent form/discussion?
A) That the trial involves research
B) Probability for random assignment to each treatment
C) Trial procedures to be followed, including invasive procedures
D) The sponsor of the trial
E) The subject’s responsibilities
F) The investigators CV

A

The following should be included:
A) That the trial involves research
B) Probability for random assignment to each treatment
C) Trial procedures to be followed, including invasive procedures

E) The subject’s responsibilities

17
Q

According to ICH GCP, how many of the following are included in the informed consent form/discussion?
A) Any foreseeable risks or inconveniences to the subject
B) Any expected benefits to the patient
C) The name of the IRB/IEC used for approval
D) Any alternative procedures / courses of treatment that are available and their benefits/risks
E) The demographics of patients the drug has been tested in previously
F) Any compensation or treatment for patients who experience a trial-related injury

A

The following should be included:
A) Any foreseeable risks or inconveniences to the subject
B) Any expected benefits to the patient

D) Any alternative procedures / courses of treatment that are available and their benefits/risks

F) Any compensation or treatment for patients who experience a trial-related injury

18
Q

According to ICH GCP, how many of the following are included in the informed consent form/discussion?
A) Other interventions that the sponsor is developing
B) Anticipated expenses the subject may incur for participating in the trial
C) That the monitor, auditor, IRB/IEC and regulatory authority will be granted access to the subjects medical records without violating their confidentiality
D) That the subject’s records will be kept confidential
E) Someone to contact for further information about he trial
F) That the subject will be informed as soon as any new information becomes available that is relevant to the subjects participation in the trial

A

The following should be included:

B) Anticipated expenses the subject may incur for participating in the trial
C) That the monitor, auditor, IRB/IEC and regulatory authority will be granted access to the subjects medical records without violating their confidentiality
D) That the subject’s records will be kept confidential
E) Someone to contact for further information about he trial
F) That the subject will be informed as soon as any new information becomes available that is relevant to the subjects participation in the trial

19
Q

According to ICH GCP, how many of the following are included in the informed consent form/discussion?
A) Any foreseeable circumstances/reasons the subject’s participation may be terminated
B) Expected duration of the subjects participation in the trial
C) Approximate number of subjects involved in the trial
D) Software used to analyze the subject’s trial data
E) Anticipated prorated payment to the subject participating in the trial
F) Contacts for the relevant regulatory authorities

A

The following should be included:
A) Any foreseeable circumstances/reasons the subject’s participation may be terminated
B) Expected duration of the subjects participation in the trial
C) Approximate number of subjects involved in the trial

E) Anticipated prorated payment to the subject participating in the trial

20
Q

According to ICH GCP, what constitutes a Serious Adverse Event (SAE) or a Serious Adverse Drug Reaction (Serious ADR)?

A

Any untoward medical occurrence that:

  • Results in death
  • Is lift threatening
  • Requires inpatient hospitalization or prolongation of existing hospitalization
  • Results in persistent or significant disability/incapacity
  • Is a birth defect
21
Q

According to ICH GCP, what is an Unexpected Adverse Drug Reaction?

A

Adverse reaction the nature or severity of which is not consistent with the applicable product information (Not in investigator’s brochure)

22
Q

According to ICH GCP, what is an Adverse Event?

A

Any untoward medical occurrence in a patient or clinical investigation subject that does NOT necessarily have a causal relationship with the treatment. Can be an unfavorable/unintended symptom or lab finding, etc.

23
Q

According to ICH GCP, what is an Adverse Drug Reaction?

A

All noxious and unintended responses to a medicinal product related to any dose. Causal relationship between the medicinal product and adverse event should beat least a reasonable possibility.

24
Q

How long should essential documents be retained by the investigator after marketing approval or discontinuation of the trial?

A

2 years.

25
Q

For an IND, what FDA form is filled out by the investigator as an agreement between the sponsor and investigator to perform the trial according to the appropriate rules and regulations?

A

FDA Form 1572.

26
Q

Which FDA forms are filled out if the Investigator has financial interests and arrangements that they need to disclose?

A

FDA Form 3455.

27
Q

Which FDA forms are filled out if the Investigator has NO financial interests and arrangements that they need to disclose?

A

FDA Form 3454.

28
Q

According to ICH GCP, the investigator should submit summaries of the trial’s status to the IRB/IEC how frequently?

A

At least annually or more often if the IRB/IEC requires it.

29
Q

According to ICH GCP, serious expected adverse events should be reported when and to who by the investigator?

A

Investigator should immediately report SAEs to the Sponsor. Detailed written reports should be submitted following the immediate report.

30
Q

According to ICH GCP, the investigator terminates or suspends a previously active trial without prior agreement of the sponsor, who(m) should the investigator inform of this decision?

A

The sponsor and the IRB/IEC with a written explanation.

31
Q

According to ICH GCP, the sponsor terminates or suspends a previously active trial, who(m) should the sponsor inform of this decision?

A

The sponsor informs the investigator, who in turn informs the IRB/IEC of the decision.

32
Q

According to ICH GCP, an IRB/IEC terminates or suspends a previously active trial, who(m) should the sponsor inform of this decision?

A

IRB/IEC informs the investigator of this decision and the investigator, in turn informs the sponsor.

33
Q

According to ICH GCP, what are the investigator’s responsibilities following the completion of a trial?

A

Investigator should provide the IRB/IEC and any relevant regulatory authorities with a final report.

34
Q

What is an Independent Data Monitoring Committee (IDMC)?

A

Established by the sponsor to assess the progress at intervals the progress of a clinical trial,t he safety data, and the efficacy endpoints and to recommend to the sponsor to continue, modify or stop a trial.

35
Q

What is a monitoring report?

A

Report written from the monitor to the sponsor after a site visit or trial-related communication.

36
Q

What does ALCOA-C stand for?

A 
Attributable
Legible
Contemporaneous
Original
Accurate
Complete

SOCRA CCRP 2020 (23 decks)

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