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Socra Study > ICH GCP > Flashcards

ICH GCP Flashcards

1
Q

Before a trial is initiated:

A

weigh risks and consequences vs benefits

anticipated benefits must justify the risk

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2
Q

Who approves a protocol?

A

IRB/IEC

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3
Q

Who makes medical decisions and gives medical care?

A

Qualified physician or dentist

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4
Q

Documents IRB/IEC should obtain

A

1) Trial protocol(s) /amendment(s)
2) written informed consent form(s) and consent form updates
3) subject recruitment procedures,
4) written information to be provided to subjects,
5) Investigator’s Brochure (IB),
6) available safety information,
7) information about
payments and compensation,
8) investigator’s current curriculum vitae and/or other documentation evidencing qualifications
9) any other documents that the IRB/IEC may need to fulfil its responsibilities.

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5
Q

How often should IRB conduct continuing reviews?

A

At least once a year (can be more depending on degree of risk to human subjects)

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6
Q

When prior consent is not possible, the IRB should:

A

should determine that the proposed protocol and/or other document(s) adequately addresses relevant ethical concerns and meets applicable regulatory requirements for such trials (i.e., in emergency situations)

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7
Q

IRB role in payments

A

To 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. Information about payments must be provided in written materials, including consent, to the subjects, including methods, amounts, and schedule. Proration must be specified.

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8
Q

Payment requirements

A

Must be prorated (not contingent on finishing the study)

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9
Q

IRB/IEC should include

A

(a) At least five members.
(b) At least one member whose primary area of interest is in a nonscientific area.
(c) At least one member who is independent of the institution/trial site.

A list of IRB/IEC members and their qualifications should be maintained.

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10
Q

Who can vote/provide opinion on a trial related matter?

A

Only those IRB/IEC members who are independent of the investigator and the sponsor of the trial should vote/provide opinion on a trial-related matter. Investigators/sponsors may provide relevant study information

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11
Q

When can the IRB make decisions?

A

At an announced meeting, with quorum. Only members who participate in the IRB/IEC review and discussion should
vote/provide their opinion and/or advice.

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12
Q

Can an IRB invite nonmembers?

A

An IRB/IEC may invite nonmembers with expertise in special areas for assistance.

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13
Q

What should the investigator promptly report to the IRB?

A

(a) Deviations from, or changes of, the protocol to eliminate immediate hazards tothe trial subjects
(b) Changes increasing the risk to subjects and/or affecting significantly the conduct of the trial
(c) All adverse drug reactions (ADRs) that are both serious and unexpected.
(d) New information that may affect adversely the safety of the subjects or the conduct of the trial.

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14
Q

What should the IRB promptly report to the investigator?

A

(a) Its trial-related decisions/opinions.
(b) The reasons for its decisions/opinions.
(c) Procedures for appeal of its decisions/opinions.

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15
Q

How long should the IRB retain relevant records?

A

3 years. Relevant records include member lists, qualifications, submitted documents, minutes, and correspondence.

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16
Q

Adequate resources the investigator should have

A

1) potential for recruitment from retrospective studies
2) sufficient time to conduct the trial
3) adequate staff and facilities
4) all staff members are properly informed about the trial

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17
Q

Who is responsible for supervising trial-related activities at the study site?

A

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

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18
Q

Can an investigator retain the use of services of an individual or party for a study?

A

Yes, but they are responsible for making sure they are qualified and need to implement procedures to ensure the integrity of the trial-related duties and functions performed and any data generated.

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19
Q

Should a investigator tell a participant’s doctor that they’re in the study?

A

Yes, if the participant consents

20
Q

Who is responsible for ensuring that adequate medical care is provided to a subject for any adverse events, including clinically significant laboratory values, related to the trial.

A

Investigator

21
Q

Should the
investigator/institution should inform a subject when medical care is needed for intercurrent illness(es) of which the investigator becomes aware?

A

Yup

22
Q

Does a participant need to give a reason why they withdraw?

A

No, but the investigator should ask

23
Q

What happens if the investigator’s brochure is updated?

A

If the Investigator’s Brochure is updated during the trial, the
investigator/institution should supply a copy of the updated Investigator’s Brochure
to the IRB/IEC.

24
Q

When can the investigator deviate from the protocol?

A

-where necessary to eliminate an immediate hazard(s) to trial subjects
- when the
change(s) involves only logistical or administrative aspects of the trial

25
Q

What should the investigator do if they deviate from the protocol?

A

the implemented deviation or change, the reasons for it, and, if appropriate, the proposed protocol amendment(s)
should be submitted to the IRB/IEC, sponsor, and regulatory authorities

26
Q

What records should be maintained of the investigational product?

A

-dates
-quantities
-batch/serial numbers
-expiration dates (if
applicable)
-unique code numbers assigned to the investigational product(s)
and trial subjects.

Investigators should maintain records that document adequately
that the subjects were provided the doses specified by the protocol and reconcile all
investigational product(s) received from the sponsor

27
Q

What to do if blinding is broken?

A

Premature blinding should be documented and explained to the sponsor.

28
Q

What do you do if new info becomes available that may be important to the subjects?

A

-update the ICF with IRB/IEC approval
-inform subjects and LARs with the information and document it

29
Q

Who should be enrolled in non-therapeutic trials?

A

Only persons who are able to give consent personally and sign and date the consent form

30
Q

When can a non-therapeutic trial include people who cannot give consent?

A

-objectives of the trial cannot be met by people who can give consent
-risks are low
-negative impact is minimized and low
-trial is not prohibited by law
-IRB/IEC is informed and approves

31
Q

How should changes/corrections to a CRF be documented?

A

They should be dated, initialed, and explained, and not obscure the original entry

32
Q

How long should essential documents be retained?

A

Investigator keeps at least 2 years, longer if required by regulatory authorities or the sponsor.

33
Q

When should the investigator give direct access to all trial related records?

A

When requested by the monitor, auditor, IRB/IEC, or regulatory authorities.

34
Q

When should the investigator submit progress reports?

A

At least annually, or more if IRB/IEC requests it. Also when changes affect conduct of the trial or increase risk to the subjects.

35
Q

Who is usually the responsible party for submitting information about the clinical trial?

A

The sponsor, unless they designate a qualified PI

36
Q

What is the goal of the ICH?

A

Standardize guidelines and requirements for drug marketing registrations

37
Q

Are ICH guidelines law in the US?

A

No, the FDA adopted it as guidance

38
Q

What are the 2 goals of ICH E6?

A

1) The rights, well-being, and confidentiality of trial subjects are protected
2) Trial data are credible

39
Q

Where do ICH E6 guidelines typically go beyond FDA or HHS requirements?

A

45 CFR 46 (Common Rule)

40
Q

What are the purposes of trial monitoring?

A

-The rights and well-being of human subjects are protected.
-The reported trial data are accurate, complete and verifiable from source documents.
-The conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with applicable regulatory requirements.

41
Q

If the investigator terminates a study, who gets told by whom?

A

If the investigator terminates or suspends a trial without prior agreement of the sponsor, the investigator should inform the institution where applicable, and the investigator/institution should promptly inform the sponsor and the IRB/IEC, and should provide the sponsor and the IRB/IEC a detailed written explanation of the termination or suspension.

42
Q

If the sponsor terminates the study, who gets told by whom?

A

If the sponsor terminates or suspends a trial (see ICH E6 Section 5.21), the investigator should promptly inform the institution where applicable and the investigator/institution should promptly inform the IRB/IEC and provide the IRB/IEC a detailed written explanation of the termination or suspension.

43
Q

If the IRB terminates a study, who gets told by whom?

A

If the IRB/IEC terminates or suspends its approval/favourable opinion of a trial (see ICH E6 Sections 3.1.2 and 3.3.9), the investigator should inform the institution where applicable and the investigator/institution should promptly notify the sponsor and provide the sponsor with a detailed written explanation of the termination or suspension.

44
Q

Point of audits?

A

QA- verify data integrity and trial processes. Could result in SOP changes or monitoring recs.

45
Q

Point of monitoring visits?

A

Assess and assure compliance with protocol.

46
Q

Point of inspections?

A

Verify data, assure compliance w/ regulations, assure subject protection. Could affect marketing applications.

47
Q

Audit vs Monitoring

A

Audit- exam of trial activities and documents
Monitoring- overseeing the progress of the clinical trial

Socra Study (14 decks)

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