Investigator roles/responsibilities

Question 1

Required qualifications of the clinical investigator

Answer 1

-qualified by education, training, and exp per regulations
-familiar with intervention
-allows sponsor to monitor and audit

Question 2

Trial-related medical/dental decisions should be made by:

Answer 2

qualified physician/dentist who is PI or SUB-I

Question 3

Who is responsible for documenting/explaining any deviation from the protocol?

Answer 3

The investigator or person designated by PI

Question 4

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

Answer 4

-Approval of change from sponsor and IRB/IEC
-If immediate hazard to trial subjects is possible or the change is logistical/administrative, approval is NOT required.

Question 5

Investigator implements a deviation from the protocol to eliminate hazard to subject w/o approval, what must happen next?

Answer 5

-ASAP: indicate reasons for change and if needed, proposed protocol changes should be submitted to
1) IRB/IEC for review
2) Sponsor for agreement
3) Regulatory bodies (only if req)

Question 6

Investigational products should be stored as specified by the ___:

Answer 6

Sponsor

Question 7

What records should be maintained for an investigational product?

Answer 7

1) Delivery of the product to site
2) Product inventory
3) Use of what product by each subject
4) Return/disposition of unused product at study termination
5) IDs, dates, quantities, S/N, and etc

Question 8

If the trial is blinded, the ___ should promptly document and explain to the ___ any premature unblinding of the investigational products.

Answer 8

Investigator, Sponsor

Question 9

When should be an ICF be revised?

Answer 9

When new information that is pertinent to subject’s consent and will require IRB/IEC approval prior to use.

Question 10

ICF should be signed AND personally dated by the ___ (or ____ if applicable) and the ___.

Answer 10

Subject (LAR), and the person who conducted consent discussion

Question 11

What if the subject or LAR is unable to read?

Answer 11

An impartial witness needs to be present during the entire discussion to attest to the consent as it was orally presented. Both subject/LAR witness must sign/date ICF.

Question 12

According to ICH GCP, which of the following is NOT included in consent discussion?
1) That the trial involves research
2) Probability for random assignment
3) Trial procedures to be followed
4) Sponsor of the trial
5) The investigator’s CV
6) Subject responsibilities

Answer 12

5

Question 13

According to ICH GCP, which of the follow is NOT included in consent discussion?
1) Foreseeable risks
2) Possible benefits
3) Name of the IRB/IEC for approval
4) Alternative procedures/course of treatment and its corresponding risk/benefits
5) Demographic of patient population previously tested
6) Possible compensation/treatment who sustain trial-related injury

Answer 13

3 & 5

Question 14

According to ICH GCP, which of the follow is NOT included in consent discussion?
1) Other interventions the sponsor is developing
2) Anticipated expenses
3) Monitor/auditor, IRB/IEC, and regulatory bodies will be granted access to their medical records, confidentially.
4) Records are confidential
5) Point of contact for study info
6) Subject will be informed ASAP regarding any new information that is pertinent to their participation

Answer 14

1

Question 15

According to ICH GCP, which of the follow is NOT included in consent discussion?
1) Foreseeable situations where subject’s participation is terminated
2) Duration of participation
3) Number of patients for study objective
4) Software for data analysis
5) Possible payments
6) Contacts for regulatory bodies

Answer 15

4

Question 16

What is considered a SERIOUS AE or SERIOUS ADR?

Answer 16

Any untoward medical occurrence that:
-Results in death
-Is life threatening
-Requires hospitalization and extension of hospitalization
-Disability
-Birth defect

Question 17

What is an UNEXPECTED ADR?

Answer 17

An adverse reaction in which the nature/severity is not consistent with the initially presented investigator brochure/consent.

Question 18

What is an AE?

Answer 18

Any untoward medical occurrence. Does not need to be causal with study treatment. (i.e. unintended symptom and/or lab findings).

Question 19

What is ADR?

Answer 19

All noxious and unintended responses to a study drug. Requires a reasonable causality between the reaction/study drug.

Question 20

How long should essential documents be retained following marketing approval/termination of the study?

Answer 20

2 years

Question 21

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

Answer 21

Form 1572 (Statement of the Investigator)

Question 22

Which FDA forms allows investigators to disclose financial interests? What form if there are NO financial interests they need to disclose?

Answer 22

Form 3455 & Form 3454

Question 23

How often should investigator submit summaries of trial status to the IRB/IEC?

Answer 23

At least annually, or per IRB/IEC requirements.

Question 24

For serious expected AEs, who should the investigator report to and when?

Answer 24

SAE need to be reported to sponsor ASAP, detailed written reports should be submitted following the initial report.

Question 25

If investigator terminates/suspends an active trial w/o prior agreement from sponsor, who should the investigator reach out to?

If sponsor terminates a trial, who should they reach out to?

If IRB/IEC terminates a trial, who should they reach out to?

Answer 25

Sponsor and IRB/IEC with written explanation.

Sponsor informs investigator, who in turns informs IRB/IEC

IRB/IEC informs investigator, who in turns informs the sponsor.

Question 26

What is a priority for investigators to complete following study completion?

Answer 26

investigator should provide IRB/IEC and relevant regulatory bodies with a final report.

Question 27

What is an Independent Data Monitoring Committee (IDMC)?

Answer 27

Established by SPONSOR to assess study progress (consents and etc) at regular intervals to assure subject safety and ascertain efficacy endpoints in order to inform sponsor if a study should continued, be modified, or be terminated.

Question 28

What is a monitoring report?

Answer 28

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

Question 29

ALCOA-C

Answer 29

Attributable
Legible
Contemporaneous
Original
Accurate
Complete
Stronger together

Question 30

Whom are generally considered vulnerable populations?

Answer 30

Individuals whose willingness to volunteer may be higher secondary to the expected benefits from the participation OR perceived RETALIATION of not participating

Question 31

Investigators must conduct their study per protocol and other regulations with utmost priority of what:

Answer 31

protection of rights, safety, and welfare of subjects (form 1572)

Question 32

Investigators must maintain “Disposition of Drug”

Answer 32

Maintain records of disposition of drug including dates, quantity, and use by subjects. Unused supplies return to sponsor

Question 33

Investigators must maintain “Case Histories”

Answer 33

Establish record of all consents, observations, and data pertinent to each subject per CRF and SOP guidelines.

Question 34

How long must investigators maintain record retention?

Answer 34

2 years of record retention following the data marketing application is approved, or pretty much as laid out in the contractual obligation by sponsor

Question 35

Who is responsible for ensuring that the study is conducted in compliance with protocol and regulatory requirements?

Answer 35

The Principal Investigator (PI) has ultimate responsibility for ensuring the study’s compliance with the protocol and regulations. Sponsor shares this role and is considered to be their “main purpose.”