Investigator roles and responsibilities

Question 1

What are the required qualifications of the clinical investigator?

Answer 1

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

Question 2

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

Answer 2

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

Question 3

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

Answer 3

True

Question 4

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

Answer 4

The investigator or person designated by the investigator.

Question 5

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

Answer 5

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.

Question 6

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?

Answer 6

-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)

Question 7

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

Answer 7

False. The investigator/institution is responsible.

Question 8

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

Answer 8

Sponsor.

Question 9

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

Answer 9

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.

Question 10

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

Answer 10

Investigator
Sponsor

Question 11

When should an investigator revise a written informed consent form?

Answer 11

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.

Question 12

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

Answer 12

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

Question 13

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.

Answer 13

True.

Question 14

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

Answer 14

2 years.

Question 15

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

Answer 15

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

Question 16

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

Answer 16

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

Question 17

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?

Answer 17

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

Question 18

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

Answer 18

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

Question 19

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

Answer 19

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

Question 20

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

Answer 20

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

Question 21

What is an Independent Data Monitoring Committee (IDMC)?

Answer 21

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

Question 22

What is a monitoring report?

Answer 22

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

Question 23

What does ALCOA-C stand for?

Answer 23

Attributable
Legible
Contemporaneous
Original
Accurate
Complete

Question 24

What is considered significant equity interest?

Answer 24

If the PI gets interest/stock options or any other financial and equity interest during the time of the study and 1 year following completion of the study.
For a publicly traded company, this means more than $50k to PI, spouse or children.

Question 25

What is considered a significant payment to an investigator in a covered clinical trial? What is considered a covered clinical trial?

Answer 25

Payments to the investigator that have a monetary value over $25k (excluding research related payments) during trial or up to 1 year after completion. A covered clinical trial is any submitted in a marketing application for the FDA proving the effectiveness of the drug/device or significantly contributes to product safety.